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Orphan Drug Designations and Approvals List as of 09 01 2016‐ ‐Governs October 1, 2016 Decemberber 31, 2016‐

of 400

Generic Name Trade Name Designation Date Designation

1

n/a 1/6/20162

ascorbic acid n/a 5/11/2009 Murigenetics SAS3

budesonide n/a 12/20/20064

n/a 1/13/2016 Treatment of cystic fibrosis5

n/a 9/11/2014 Treatment of empyema (pleural)6

n/a 10/12/2011 Treatment of Fragile X syndrome7

n/a 8/22/2016 SCYNEXIS, Inc.8

n/a 6/5/2013 Treatment of pancreatic cancer EMD Serono9

n/a 3/9/2012 Treatment of soft tissue sarcoma

Row Num

Contact Company/Sponsor

1-(2-Nitro-imidazolyl)-3-[18F]fluoro-2-propanol;1H-1-(3-[18F]fluoro-2-hydroxypropyl)-2-nitroimidazole

As a diagnostic for clinical management of soft tissue sarcoma, including rhabdomyosarcoma.

Advanced Imaging Projects, LLC

Treatment of Charcot-Marie-Tooth disease type 1A.

Treatment of patients with eosinophilic esophagitis

Shire ViroPharma Incorporated

S-nitrosoglutathione reductase inhibitor

Nivalis Therapeutics, Inc.

single chain urokinase plasminogen activator

Lung Therapeutics, Inc.

(-)-(3aR,4S,7aR)-4-Hydroxy-4-m-tolylethynyl-octahydro-indole-1-carboxylic acid methyl ester

Novartis Pharmaceuticals Corp.

(1,3)-ß-D-glucan synthesis inhibitor

Treatment of invasive Aspergillus infections

(1-methyl-2-nitro-1H-imidazole-5-yl)methyl N,N'-bis(2-broethyl) diamidophosphate

(1-methyl-2-nitro-1H-imidazole-5-yl)methyl N,N'-bis(2-bromoethyl) diamidophosphate

Threshold Pharmaceuticals, Inc.


of 400

Generic Name Trade Name Designation Date DesignationRow Num


10

n/a 6/23/2015 Pfizer, Inc.11

n/a 2/17/2009 Pfizer, Inc.12

n/a 8/13/200413

n/a 1/29/200414

n/a 8/10/2004

(1OR)-7-amino-12-fluoro-2,10,16-trimethyl-15 oxo-10,15,16,17-tetrahydro-2H-8,4-(metheno)pyrazolo[4,3-h][2,5,11]benzoxadiazacyclotetradecine-3-carbonitrile

Treatment of anaplastic lymphoma kinase (ALK)-positive or ROS1-positive non-small cell lung cancer

(1R,3R,4R,5S)-3-O-[2-O-benzoyl-3-O-(sodium(2S)-3-cyclohexyl-propanoate-

Treatment of vaso-occlusive crisis in patients with sickle cell disease.

(1S)-1-(9-deazahypoxanthin-9-yl)-1,4-dideoxy-1,4-imino-D-ribitol-hydrochloride

Treatment of acute lymphoblastic leukemia

Mundipharma Research Limited


Treatment of T-cell non-Hodgkin's lymphoma

Mundipharma Research Limited


Treatment of chronic lymphocytic leukemia and related leukemias to include prolymphocytic leukemia, adult T-cell leukemia, and hairy cell leukemia

Mundipharma Research Ltd.


of 400



15

n/a 9/15/2010 Treatment of infantile spasms.16

n/a 6/23/201417

n/a 5/18/2016 Treatment of Rett Syndrome.18

n/a 11/29/2016 Treatment of multiple myeloma19

n/a 10/14/2015 Treatment of systemic sclerosis.

(1S,3S)-3-amino-4-(difluoromethylene)cyclopentanecarboxylic acid hydrochloride, (1S,3S)-3-amino-4-difluoromethylenyl-1-cyclopentanoic acid hydrochloride

Catalyst Pharmaceuticals, Inc.

(2'R,3'S)-2'-hydroxy-N-carboxy-3'-amino-5'-methyl-hexanoic,N-tert-butyl ester, 13 ester 5B-20-epoxy-1B,2a,4a,7B,9a,10a,13a-heptahydroxy-4,10-diacetate-2-benzoate-(1"S)-7,9-acrolein acetal-11(15-1)-abeotaxane

Treatment of progressive supranuclear palsy

Cortice Biosciences, Inc.

(2,2-diphenyl-tetrahydro-furan-3-yl-methyl)-dimethylamine hydrochloride

Anavex Life Sciences Corporation

(2-((2-chlorophenyl)(phenyl)amino)-N-(7-(hydroxyamino)-7-oxoheptyl)pyrimidine-5-carboxamide)

Acetylon Pharmaceuticals, Inc.

(2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1h-pyrazolo [4,3-c] pyridine-3,6(2h,5h)-dione)

Genkyotex Innovation SAS


of 400



20

n/a 12/2/2010 QLT Inc.21

n/a 12/2/2010 QLT, Inc.22

n/a 10/31/2012 Albireo AB23

n/a 10/31/2012 Albireo AB

(2E, 4E, 6Z, 8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-l-yl) nona-2,4,6,8-tetraen-l-yl acetate

Treatment of retinitis pigmentosa

(2E,4E,6Z,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-enyl)nona-2,4,6,8-tetraenyl acetate 9-cis-retinyl acetate (API)

Treatment of Leber congential amaurosis (LCA) due to inherited mutations in RPE65 (encoding the protein retinal pigment epithelial protein 65) or LRAT (encoding the enzyme lecithin:retinol acyltransferase)genes.

(2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid

Treatment of primary biliary cirrhosis

(2S)-2-{[(2R)-2-[({[3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid

Treatment of progressive familial intrahepatic cholestatis


of 400



24

Fk778 1/10/200525

n/a 3/18/201126

n/a 3/18/2011 Treatment of pancreatic cancer27

n/a 3/18/2011 Treatment of Glioma28

n/a 4/30/2014 Treatment of multiple myeloma VivoLux AB29

n/a 12/9/201530

n/a 9/11/2014 Treatment of Gaucher disease Genzyme

(2Z)-2-cyano-3-3hydroxy-N-[4-(trifluoromethly)phenyl]-2-hepten-6-ynamide

Prevention of acute rejection following kidney, heart, and liver transplantation

Fujisawa Healthcare, Inc.

(3,5-Bis trifluoromethyl)-N-[4-methyl-3-(4-pyridin-3yl-pyrimidin-2-yl amino) phenyl] benzamide

Treatment of chronic myelogenous leukemia.

NATCO Pharma Limited

(3,5-Bis trifluoromethyl)-N-[4-methyl-3-(4-pyridin-3yl-pyrimidin-2-yl amino) phenyl] benzamide


(3,5-Bis trifluoromethyl)-N-[4-methyl-3-(4-pyridin-3yl-pyrimidin-2-yl amino) phenyl] benzamideNRC-AN-019


(3E,5E)-3,5-bis[(4-fluoro-3-nitrophenyl)methylidene]-1-(prop-2-enoyl)azepan-4-0ne

(3S)-(+)-(5-chloro-2-methoxyphenyl)-1,3-dihydro-3-fluoro-6-(trifluoromethyl)-2H-indol-2-one

Treatment of Fragile X Syndrome.

Centre National de la Recherche Scientifique (CNRS)

(3S)-1-azabicyclo[2.2.2]oct-3-yl {2-[2-(4-fluorophenyl)-1,3-thiazol-4-yl]propan-2-yl}carbamate


of 400



31

n/a 8/26/2014 Treatment of Fabry's disease Genzyme Corporation32

n/a 7/5/2007 Treatment of tuberculosis33

n/a 8/19/200334

n/a 4/25/201635

n/a 9/18/2015 AbbVie, Inc.

(3S)-1-azabicylo[2.2.2]oct-3yl {2-[2-(4-fluorophenyl)-1,3-thiazol-4-yl]propan-2-yl}carbamate

(3S)-3-(4-trifluoromethoxybenzyloxy)-6-nitro-2H-3,4-dihydroimidazo[2,1-b]oxazine

Global Alliance for TB Drug Development

(3S)-3-[(2S)-2-({N-[2-tert-butyl)phenyl]carbamoyl}carbonylamino) propanoylamino]-4-oxo-5-(2,3,5,6-tetrafluorophenoxy) pentanoci acid

Treatment of patients undergoing solid organ transplantation.

Pfizer Global Research and Development

(3S)-3-[({1-(2-Chlorobenzyl)-4-hydroxy-5-methyl-2-oxo-1,2-dihydropyridin-3yl}amino)carbonyl]amino-3-(4-methylphenyl)propanoic acid monosodium salt

For mobilization of hematopoietic stem cells

Aviara Pharmaceuticals, Inc/

(3S,4R)-3-Ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide (2R,3R)-2,3-dihydroxybutanedioate

Treatment of pediatric (aged 0 through 16 years) juvenile idiopathic arthritis (JIA) ILAR categories excluding systemic JIA


of 400



36

n/a 9/4/2013 Treatment of alagille syndrome37

n/a 9/4/201338

n/a 9/4/201339

n/a 7/24/2013

(4R,5R)-1-[[4-[[4-[3,3-Dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-l-azoniabicyclo[2.2.2]octane Chloride

Shire Human Genetic Therapies, Inc.





Treatment of primary sclerosing cholangitis


(5R)-5-(4-{[2-fluorophenyl)methyl]oxy}phenyl)-L-prolinamide, hydrochloride

Treatment of trigeminal neuralgia

Convergence Pharmaceuticals Ltd.


of 400



40

n/a 4/14/2016 Treatment of ovarian cancer41

n/a 6/29/2011 Treatment of soft tissue sarcoma CytRx Corporation42

n/a 2/21/201443

n/a 10/13/2015 Treatment of cystic fibrosis.44

n/a 6/10/2015 Treatment of systemic sclerosis45

Cofactor 8/13/2004

(5S,8S, 10aR)-N-benzhydryl-5-((S)-2-(methylamino)propanamido)-3-(3-methylbutanoyl)-6-oxodecahydropyrrolo[1,2-a][1,5] diazocine-8-carboxyamide

DebioPharm International SA

(6-maleimidocaproyl)hydrazone of doxorubicin

(6-[4-Deoxy-4-[(2E,4E)-tetradecadienoylglycyl] amino-L-glyceroB-L-manno-heptopyranosyl]amino-9H-purine)

Parenteral treatment of painful, chronic, chemotherapy-induced peripheral neuropathy that is refractory to conventional analgesics

DARA BioSciences, Inc.

(6aR, 10aR)-3-(1’,1’-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid

Corbus Pharmaceuticals, Inc.

(6aR, 10aR)-3-(1â¿¿,1â¿¿-dimethylheptyl)-Î¿8-tetrahydro-cannabinol-9-carboxylic acid

Corbus Pharmaceuticals, Inc.

(6R,S)5,10-methylene-tetrahydrofolic acid

For use in combination with 5-fluorouracil for the treatment of patients with pancreatic cancer

Adventrx Pharmaceuticals, Inc.


of 400



46

n/a 12/8/200447

n/a 4/21/2016 Neem Biotech Ltd.48

n/a 3/19/201549

n/a 3/9/2012 Atterocor, Inc.50


n/a 4/15/2011

(9-[N-(3-morpholinopropyl)-sulfonyl]-5,6-dihydro-5-oxo-11-H-indeno [1,2-c] isoquinoline methanesulfonic acid

Prevention of post-operative complications of aortic anuerysm surgical repair

Inotek Pharmaceuticals Corporation

(E, Z)-4,5,9-trithiadodeca-1, 6, 11-triene 9-oxide (Ajoene)

Treatment of Pseudomonas aeruginosa pulmonary infections in cystic fibrosis patients

(monomethoxypolyethylene glycol) recombinant adenosine deaminase

Treatment of adenosine deaminase deficiency in patients with severe combined immunodeficiency

Sigma-Tau Pharmaceuticals, Inc.

(N-[2,6-bis(1-methylethyl)-pheyl-N'-[[1-4-dimethyl-amino)phenyl]cyclopentyl]methyl]urea, hydrochloride salt

Treatment of adrenocortical carcinoma

(R)-1-(2,2-difluorobenzo [d][1,3] dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl) cyclopropanecarboxamide

Vertex Pharmaceuticals Inc.

(R)-1-phenylethyl-5-(4-biphenyl-4-cyclopropanecarboxylic acid)-3-methylisoxazole-4-yl carbamate sodium salt

Treatment of idiopathic pulmonary fibrosis

Bristol-Myers Squibb Company


of 400



52

n/a 5/12/2016 Trio Medicines Ltd.53

n/a 7/12/200754

n/a 12/19/2007 AbbVie, Inc55

n/a 11/19/2015 ArQule, Inc.

(R)-1-[1-(4-Acetoxy-3,3-dimethyl-2-oxo-butyl)-2-oxo-5-(pyridin-2-yl)-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-3-(3-methylamino-phenyl)-urea

Treatment of gastric neuroendocrine tumors (gastric NETs).

(R)-2-methyl-6-nitro-2-{4-[4-(4-trifluoromethoxyphenoxy)piperidin-1-yl]phenoxymethyl}-2,3-dihydroimidazo[2,1-b]oxazole

Treatment of pulmonary tuberculosis.

Otsuka Pharmaceutical Company, Ltd

(R)-4-(3-morpholin-4-yl-1-phenylsulfanylmethyl-propylamino)-N-(4-{4-[2-(4-chlorophenyl)-5,5-dimethylcyclohex-1-enylmethyl]-piperazin-1-yl}-benzoyl)-3-trifluoromethanesulfonylbenzenesulfonamide bis-hydrochloride

Treatment of small cell lung cancer.

(R)-6-(2-fluorophenyl)-N-(3-(2-((2-methoxyethyl)amino)ethyl)phenyl)-5,6-dihydrobenzo[h]quinazolin-2-amine dihydrochloride

Treatment of cholangiocarcinoma.


of 400



56

n/a 10/3/200157

n/a 7/3/200358

n/a 3/17/2014 Pharnext SA59

n/a 11/5/2014 BerGenBio AS60

Lipotecan 10/6/2010

(R)-N-[2-(6-chloro-5-methoxy-1H-indol-3-yl)propyl]acetamide

Treatment of circadian rhythm sleep disorders in blind people with no light perception

Phase 2 Discovery, Inc.

(R)-N-[2-(6-Chloro-methoxy-1H-indol-3yl)propyl]acetamide

Treatment of neuroleptic-induced tardive dyskinesia in schizophrenia patients

Phase 2 Discovery, Inc.

(RS)-baclofen, naltrexone and D-sorbitol

Treatment of Charcot-Marie-Tooth disease type 1A

(S)-1-(6,7-Dihydro-5H-benzo[6,7]cyclohepta[1,2-c]pyridazin-3-yl)-N3-(7-(pyrrolidin-1-yl)-6,7,8,9-tetrahydro-5H-benzo[7]annulen-2-yl)-1H-1,2,4-triazole-3,5-diamine

Treatment of acute myeloid leukemia

(S)-10-[(dimethylamino)methyl]-4-ethyl-9hydroxy-4-O-[a-(2",4",5",7"-tetranitro-9"-fluorenylideneaminooxy)propionyl]- 1H-pyrano[3',4',6',7',] indolizino [1,2-B]-quinoline-3, 14-(4H, 12H)-dione, hydrochloride

Treatment of hepatocellular carcinoma

TLC Biopharmaceuticals, Inc.


of 400



61

n/a 1/26/2015 Treatment of pemphigus vulgaris Almirall S.A.62

n/a 11/17/2014 Pulmokine, Inc.63

n/a 8/1/201364

n/a 2/4/200965

n/a 6/24/2013

(S)-2-(1-((6-amino-5-cyanopyrimidin-4-yl)amino)ethyl)-4-oxo-3-phenyl-3,4-dihydropyrrolo[2,1-f][1,2,4]triazine-5-carbonitrile

(S)-3-((3-(1-((6-((3,4-dimethoxyphenyl)pryazin-2-yl)amino)ethyl)phenyl)carbamoyl)-5-methylpridin-1-ium

Treatment of pulmonary arterial hypertension

(S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one

Treatment of follicular lymphoma

Infinity Pharmaceuticals, Inc.

(S)-4,5-dihydro-2[2-hydroxy-3-(3,6,9-trioxadecyloxy)phenyl]-4-methyl-4-thiaxolecarboxylic acid

Treatment of chronic iron overload in patients with transfusion-dependent anemias

Ferrokin BioSciences, Inc.

(S)-4-(5-chloro-2-(isopropylamino)pyridin-4-yl)-N-(1-(3-chlorophenyl)-2-hydroxyethyl)-1H-pyrrole-2-carboxamide hydrochloride

Treatment of Stage IIb through Stage IV BRAF mutant melanoma

BioMed Valley Discoveries, Inc.


of 400



66

n/a 10/22/2015 Acerta Pharma BV67


n/a 11/17/2014 Khondrion BV69

n/a 4/29/2015 Treatment of Hodgkin lymphoma Incyte Corporation70

n/a 6/23/2016 BeiGene USA, Inc.

(S)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-yl)-imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)-benzamide

Treatment of Waldenstrom macroglobulinemia.

(S)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-yl)-imidazo[1,5-a]pyrazine-1-yl)-N-(pyridine-2-yl)-benzamide

Treatment of mantle cell lymphoma.

(S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride

Treatment of inherited mitochondrial respiratory chain diseases

(S)-7-(1-(9H-purin-6-ylamino)ethyl)-6-(3-fluorophenyl)-3-methyl-5H-thiazolo[3,2-a]pyrimidin-5-one

(S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetrahydroprazolo[1,5-a]pyrimidine-3-carboxamide



of 400



71

n/a 6/29/2016 BeiGene USA, Inc.72

n/a 7/20/2016 BeiGene USA, Inc.73

n/a 10/6/201574

n/a 8/31/2015 Loxo Oncology, Inc.75

n/a 11/12/2014 Treatment of glioma76

n/a 3/28/2006 Auris Medical, Inc.

(S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetrahydropyrazolo[1,5-a]pyrimidine-3-carboxamide

Treatment of Waldenstrom's macroglobulinemia

(S)-7-(1acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetrahydropyrazolo[1,5-a]pyrimidine-3-carboxamide

Treatment of chronic lymphocytic leukemia.

(S)-8-{2-Amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester

Treatment of pulmonary arterial hypertension (PAH).

KAROS Pharmaceuticals, Inc.

(S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate

Treatment of soft tissue sarcoma.

(S)-perillyl alcohol temozolomide

NeOnc Technologies, Inc.

(UDU-stereoisomer of c-UJUun UNU-terminal UkUnhibitor)

Treatment of acute sensorineural hearing loss


of 400



77

n/a 5/14/201478


n/a 11/19/2012 Treatment of erythromelalgia Teva Pharmaceuticals80

n/a 1/31/2012 Treatment of malignant gliomas81

1,2:5,6-dianhydrogalactitol n/a 3/10/2016 Treatment of medulloblastoma.82

1,2:5,6-dianhydrogalactitol n/a 4/19/2016 Treatment of ovarian cancer.83

n/a 5/12/1998 Treatment of Fabry's disease. Oxford GlycoSciences84

n/a 4/6/201685

Sapacitabine 6/24/2010 Cyclacel Limited

(Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N-(pyrazin-2-yl)acrylohydrazide

Treatment of diffuse large B-cell lymphoma

Karyopharm Therapeutics, Inc.

1 8-(p[131I]-iodophenyl)octadecyl phosphocholine

Cellectar Biosciences, Inc.

1'-{[5-(trifluoromethyl)-2-furyl]methyl}spiro[furo[2,3-f][1,3]benzodioxole-7,3'-indol]-2'(1'H)-one

1,2:5,6-Dianhdrogalactitol, NSC-132313

DelMar Pharmaceuticals, Inc.

DelMar Pharmaceuticals, Inc.

DelMar Pharmaceuticals, Inc. (Clinical Operations)

1,5-(Butylimino)-1,5 dideoxy,D-glucitol

1-(2,8-Dimethyl-1-thia-3,8-diazaspiro[4.5]dec-3-yl)-3-(1H-indol-3-yl)propan-1-one

Treatment of frontotemporal dementia.

Anavex Life Sciences Corp.

1-(2-C-cyano-2-deoxy-B-D-arabino-pentafuranosyl)-N4-palmitoylcytosine

Treatment of acute myelogenous leukemia


of 400



86

Sapacitabine 6/24/2010 Cyclacel Limited87

n/a 7/7/2016 Treatment of status epilepticus88

n/a 4/6/201689

n/a 9/1/2011 Eisai, Inc.90


n/a 3/31/2015 Treatment of systemic sclerosis Inventiva Pharma92

n/a 11/12/2009

1-(2-C-cyano-2-deoxy-B-D-arabino-pentafuranosyl)-N4-palmitoylcytosine

Treatment of myelodysplastic syndrome

1-(2-chlorophenyl)-1-(S)-hydroxy-2-(S)-carbamoyloxy-propane

Bio-Pharm Solutions Co., Ltd.

1-(2-Nitro-imidazolyl)-3-[18F]fluoro-2-propanol; 1H-1-(3-[18F]fluoro-2-hydroxypropyl0-2-nitroimidazole (18F-Misonidazole)

Diagnostic for management of glioma.


1-(3-chloro-5-{[4-(4-chloro-2-thienyl)-5-(4-cyclohexylpiperazin-l-yl)-1,3-thiazol-2-yl]carbamoyl}- 2-pyridyl) piperidine-4-caboxylic acid Monomaleate

Treatment of idiopathic thrombocytopenic purpura

1-(4-(benzylamino)-7,8-dihydro-5H-pyrano[4,3-d]pyrimidin-2-yl)-2-methyl-1H-indole-4-carboxamide

Cleave Biosciences, Inc.

1-(6-benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid

1-Cyclopropyl-3-[3-(5-morpholin-4-ylmethyl-1H-benzoimidazol-2-yl)-1H-pyrazol-4-yl]-urea


Astex Therapeutics Ltd


of 400



93

n/a 1/9/2012 ViroDefense, Inc.94

n/a 1/23/201395

111Indium pentetreotide Somatother 6/10/199996

n/a 6/7/2011 Treatment of pancreatic cancer Oncos Therapeutics97

n/a 8/29/2016 Treatment of neuroblastoma98

n/a 3/28/201699

17 amino acid peptide n/a 1/29/2010100

n/a 6/1/2015 Lipocine, Inc.

1-[(2-Chloro-4-methoxyphenoxy)methyl]-4-[(2,6-dichlorophenoxy) methyl]benzene

Treatment of poliovirus infection.

10 synthetic peptides targeting 5 tumor asociated antigens

Treatment of non-small cell lung cancer in patients expressing HLA-A2

Orphan Synergy Europe Pharma (OSE Pharma)

Treatment of somatostatin receptor positive neuroendocrine tumors.

Louisiana State University Medical Center Foundation

12-A-p21 RAS(5-21). 12-C-p21 RAS(5-21). 12-D-p21 RAS(5-21). 12-Rp21 RAS(5-21). 12-S-p21 RAS(5-21). 12-V-p21 RAS(5-21). 13-D-p21 RAS(5-21)

131-I-8H9 monoclonal antibody

Memorial Sloan Kettering Cancer Center

131I-BC8 monoclonal antibody (Anti-CD45 murine monoclonal antibody radiolabeled with 131I

Treatment of Acute Myeloid Leukemia (AML)

Actinium Pharmaceuticals, Inc.

Prevention of ischemia reperfusion injury in the lung during lung tranplantation

Apeptico Forschung und Entwicklung GmbH

17-a-hydroxyprogesterone caporate (oral formulation)

Prevention of preterm birth in women with a singleton pregnancy


of 400



101

n/a 9/3/2004102

n/a 4/16/2015 SolaranRx, Inc.103

177Lu-tetraxetan-tetulomab Betalutin 5/14/2014 Nordic Nanovector AS104

n/a 4/30/2014105

n/a 1/26/2015106

n/a 2/17/2016107

2 dimethylbutyrate n/a 6/18/2008 Treatment of beta thalassemia108

2'-deoxycytidine n/a 9/9/1996 Grant, Steven M.D.

17-allylamino-17-demethoxygeldanamycin (17-AGG)

Treatment of chronic myelogenous leukemia


177-LU-DOTA-GlyGlyNle-CycMSHhex

Treatment of Stage IIB through IV malignant melanoma

Treatment of Follicular Lymphoma

18-(p-[124I]-iodophenyl)octadecyl phosphocholine

Diagnostic for the management of glioma

Cellectar Biosciences, Inc.

18Fluorine-N-3-Fluoropropyl-2beta-carbomethoxy-3beta-(4-iodophenyl) Nortropane

Diagnostic to be used in the management of multiple system atrophy (MSA)


1E,6E)-1,7-Bis(3,4-dimethoxyphenyl)-4-cyclobutylmethyl-1,6-heptadiene-3,5-dione or [(1E, 4Z,6E)-4-(cyclobutylmethyl)-1,7-bis(3,4-dimethoxyphenyl)-5-hydroxyhepta-1,4,6-trien-3-one]

Treatment of spinal and bulbar muscular atrophy

Allianz Pharmascience Ltd.

HemaQuest Pharmaceuticals, Inc.

As a host-protective agent in the treatment of acute myelogenous leukemia.


of 400



109

n/a 5/10/2016 Treatment of acromegaly110

n/a 10/31/2012 LifeSplice Pharma LLC111

n/a 3/9/2012112

n/a 1/15/2015113

n/a 9/10/2015 InFlectis BioScience114

n/a 9/21/2010 GenKyoTex S.A.

2'-O-(2-methoxyethyl)phosphorothioate antisense oligonucleotide

Antisense Therapeutics Limited

2'-O-methyl phosphorothioate 5'-GCUAGGUUUACGGGACCUCU-3'

Treatment of amyotrophic lateral sclerosis

2,2'-{2-[1R)-1-({[(2,5-dichlorobenzoyl)amino]acetyl}amino)-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid (ixazomib citrate)

Treatment of systemic light chain (AL) amyloidosis.

Millennium Pharmaceuticals, Inc.

2,5-dimethyl-3-[2-methyl-4-(methyloxy)phenyl]-N-[(1S)-1-(3-methyl-1,2,4-oxadiazol-5-

Treatment of congenital adrenal hyperplasia (CAH)

Neurocrine Biosciences, Inc.

2-(2-chlorobenzylidene)hydrazinecarboximidamide acetate

Treatment of Charcot-Marie Tooth disease.

2-(2-chlorophenyl)-4-[3-(dimethylamino)phenyl]-5-methyl-1H-pyrazolo[4,3-C]pyridine-3,6(2H,5H)-dione

Treatment of idiopathic pulmonary fibrosis.


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n/a 12/22/2008 Treatment of multiple myeloma. EntreMed, Inc.118

n/a 3/18/2009 Treatment of ovarian carcinoma EntreMed, Inc.119

n/a 1/26/2015 Treatment of pancreatic cancer Incyte Corporation120

Atiprimod 12/2/2003

2-(2-phenylvinyl)-4-[-methylpiperazin-l-yl)]-6-(5-methyl-2H-pyrazol-3-yl-amino)-pyrimidine L(+) tartrate salt

Treatment of acute myeloid leukemia.

2-(2-phenylvinyl)-4-[4-methylpiperazin-1-yl)]-6-(5-methyl-2H-pyrazol-3-yl-amino)-pyrimidine L(+) tartrate salt


CASI Pharmaceuticals, Inc.

2-(2-phenylvinyl)-4-[4-methylpiperazin-l-yl)]-6-(5-methyl-2H-pyrazol-3-yl-amino)-pyrimidine L(+) tartrate salt

2-(2-phenylvinyl)-4-[4-methylpiperazin-l-yl)]-6-(5-methyl-2H-pyrazol-3-ylamino)-pyrimidine L(+) tartrate salt

2-(3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-l-yl)-1-(1-(3-fluoro-2-(trifluoromethyl)isonicotinoyl)piperidin-4-yl)azetidin-3-yl)acetonitrile adipate

2-(3-diethylaminopropyl)-8,8-dipropyl-2-azaspiro [4,5] decan dimaleate

Treatment of mulitple myeloma and associated bone resorption

Callisto Pharmaceuticals, Inc.


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Atiprimod 9/18/2006 Treatment of carcinoid tumors122

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2-0-desulfated heparin Aeropin 9/17/1993 Treatment of cystic fibrosis.126

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2-(3-Diethylaminopropyl)-8,8-dipropyl-2-azaspiro[4,5] decane dimaleate


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Aptose Biosciences, Inc.

2-(7-ethoxy-4-(3-fluorophenyl)-1-oxophthalazin-2(1H)-yl)-N-methyl-N-(2-methylbenzo[d]oxazol-6-yl)acetamide

2-0-Butyryl-1-0-octyl-myo-inositol 3,4,5,6-tetrakisphosphate

Kennedy & Hoidal, M.D.'s

2-amino-2-[2-[2-chloro-4-[[3-(phenylmethoxy) phenyl] thio]phenyl]ethyl]1,3-propanediol hydrochloride

Prevention of graft versus host disease.

Novartis Pharmaceuticals Corporation

2-amino-3-[3-[[4-(2-pyridyloxymethyl)phenyl]methyl]isoxazol-5-yl]pyridin-1-ium-1-yl]methyl hydrogen phosphate

Treatment of invasive aspergillosis

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n/a 11/3/2016 Treatment of coccidioidomycosis131

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n/a 8/3/2001 Treatment for malignant gliomas


Treatment of invasive rare mold infections caused by scedosporium spp., fusarium spp., and mucorales fungi (including mucor spp., and rhizopus spp.)






2-amino-N-({methyl-[(6-trifluoromethoxy-benzothiazol-2-ylcarbamoyl)-methyl]-carbamoyl}-methyl)-acetamide monohydrochloride

Treatment of spinocerebellar ataxia.

Biohaven Pharmaceuticals, Inc.

2-Chloro-N6--(3-iodobenzyl)adenosine-5'-N-methyluronamide


Can-Fite BioPharma Ltd.

2-chloroethyl-3-sarcosinamide-1-nitrosourea

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Kleptose 2/18/2013 Vtesse, Inc.138

2-iminobiotin n/a 2/24/2009 Treatment of perinatal asphyxia. Neurophyxia B.V.139

2-methoxyestradiol Pulmolar 4/11/2005140

n/a 4/9/2015 Treatment of anal cancer Eli Lilly and Company

2-chloroethyl-3-sarcosinamide-1-nitrosourea

2-Ethylbutyl (2S)-2-{[(S)-{[(2R,3S,4R,5R)-5-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-5-cyano-3,4-dihydroxytetrahydrofuran-2-yl]methoxy}(phenoxy)phosphoryl]amino}propanoate

2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl) methoxy)benzaldehyde

Treatment of sickle cell disease (SCD).

Global Blood Therapeutics, Inc.

2-hydroxypropyl-B-cyclodextrin

Treatment of Niemann Pick disease, type C.


PR Pharmaceuticals, Inc.

2-Pyrazinecarbonitrile, 5-[[5-2-(3-aminopropoxy)-6-methoxyphenyl]-1H-pyrazol-3-yl]amino] monomesylate monohydrate


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2-[(3-methyl-4-(2,2,2-trifluoroethoxy) pyridin-2-yl)methylsulfinyl] -1H-benzoimidazole

Treatment of hepatocellular carcinoma.

2-[(4S)-6-(4-chlorophenyl)-1,7,8-trimethylthiophenol[3,2-f]1,2,4-triazolo[4,3-a]1,4-diazepin-4-yl]-N-[3-(4-methylpiperazinyl)propyl]acetamide

Treatment of nuclear protein in testis (NUT) midline carcinoma.

Genentech, Inc (a Roche Group Member)

2-[(6S)-4-(4-chlorophenyl)-2,3,9-trimethyl-6H-thienol[3,2,-f]-[1,2,4]triazolo[4,3-a][1,4]diazepin-6-yl]-N-(4-hydroxyphenyl)-acetamide dihydrate


2-[(R)-2-methylpyrrolidin-2-yl]-1H-benzimadazole-4-carboxamide

Treatment of malignant melanoma stages IIb through IV.

2-[4-(1-Methyl-4-pyridin-4-yl-lH-pyrazol-3-yl)-phenoxymethyl]-quinoline succinic acid

Treatment of Huntington's disease.

2-[4-Methoxy-3-(2-m-tolyl-ethoxy)-benzoylamino]-indian-2-carboxylic acid

Treatment of patients with systemic sclerosis


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2-[4-[[(2-R)-2-ethoxy-3-[4-(trifluoromethyl)phenoxy]propyl]thio]-2-methylphenoxy]acetic acid (1:1) lysine dihydrate

Treatment of patients with Frederickson Type I or V hyperlipoproteinemia

CymaBay Therapeutics, Inc.

2-[4-[[(2R)-2-ethoxy-3-[4-(trifluoromethyl)phenoxy]propyl]thio]-2-methylphenoxy]acetic acid (1:1) lysine dihydrate

Treatment of primary biliary cholangitis

CymaBay Therapeutics

2-[4-[[(2R)-2-ethoxy-3-[4-(trifluoromethyl)phenoxy]propyl]thio]-2-methylphenoxy]acetic acid (1:1) lysine dihydrate

Treatment of homozygous familial hypercholesterolemia (HoFH)

CymaBay Therapeutics, Inc.

2-[[3-({4-[(5-{2-[(3-Fluorophenyl)amino]-2-oxoethyl}-1H-pyrazol-3-yl)amino]-quinazolin-7-yl}propyl](ethyl)amino]ethyl dihydrogen phosphate trihydrate


AstraZeneca Pharmaceuticals LP

2-{3-[(3R)-3-({[2-chloro-3-(trifluoromethyl)phenyl]methyl}(2,2-diphenylethyl)amino)butoxy]phenyl}acetic acid


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n/a 12/1/2004 Rexahn Corporation157

n/a 12/8/2004 Treatment of pancreatic cancer Rexahn Corporation158

n/a 12/1/2004 Treatment of ovarian cancer Rexahn Corporation159

n/a 12/8/2004 Treatment of glioblastoma Rexahn Corporation160

225Ac-lintuzumab n/a 11/25/2014


Treatment of glioblastoma multiforme.


Treatment of malignant melanoma stages IIB to IV.

2-{[(1r,4r)-4-(((4-chlorophenyl)(phenyl)carbamoyloxy)methyl)cyclohexy]methoxy} acetic acid


Arena Pharmaceuticals, Inc.

20-mer complementary to Akt mRNA

20-mer oligonucleotide complementary to Akt mRNA

Treatment of renal cell carcinoma





Actinium Pharmaceuticals, Inc.


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163n/a 4/30/2010

164

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Treatment of uremic osteodystrophy.

Treatment of endogenous Cushing's syndrome

Cortendo AB (HQ address)

3,4 diaminopyridine and choline bitartrate

Treatment of Lambert-Eaton myasthenic syndrome

MS Therapeutics Limited

Treatment of Lambert-Eaton myasthenic syndrome.

Jacobus Pharmaceutical Company

Treatment of well-differentiated papillary, follicular or combined papillary/follicular carcinomas of the thyroid gland.

Elliot Danforth, Jr., M.D.

Treatment of Allan-Herndon-Dudley syndrome

Zarion Pharmaceuticals P/L

3-(3,5-dimethyl-1H-2ylmethylene)-1,3-dihydro-indol-2-one

3-(3,5-Dimethyl-1H-2ylmethylene)-1,3-dihydro-indol-2-one

Treatment of von Hippel-Lindau disease.

3-(4-(1,5-Napthrydine)-Imidazole[1,2-a]pyridine-7-(1-phenyl-4-(1-(4-methyl piperazine)

Treatment of fibrodysplasia ossificans progressiva.

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3-bromopyruvate n/a 3/5/2013175

3-bromopyruvate n/a 4/29/2014 Treatment of pancreatic cancer PreScience Labs, LLC176

n/a 10/25/2013 Treatment of Rett syndrome Neurolixis, Inc.177

n/a 7/28/2008 Seaside Therapeutics

3-(4-(8-fluoroquinoline)-Imidazole[1,2-a]pyridine-7-(1-phenyl-4-(1-(4-methyl piperazine)

Treatment of fibrodysplasia ossificans progressiva.


3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride


3-(5-Fluoro-benzofuran-3-yl)-4-(5-methyl-5H-[1,3]dioxolo[4,5-f]indol-7-yl)-pyrrole-2,5-dione

3-(6-(1-(2,2-difluorobenzo[d] [1,3]dioxyl-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid


Treatment of liver and intrahepatic bile duct cancer

Primocure Pharma, Inc.

3-chloro-4-fluorophenyl-[4-fluoro-4-[[(5-methylpyrimidin-2-ylmethyl)amino]methyl]piperidin-1yl]methanone

3-fluoro-5-[5-(2-menthyl-thiazol-4-ylethylnyl)-pyridin-2-yl]-benzonitrile dihydrochloride

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3-[2-(4-carbamimidoyl-phenylcarbamoyl)-5-methoxy-4-vinyl-phenyl]-6-(cyclopropylmethyl-carbamoyl)-pyridine-2-carboxylic acid

Prevention of acute attacks of angioedema in individuals with hereditary angioedema

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3-{3-[4-(1-aminocyclobutyl)phenyl]-5-phenyl-3H-imidazo[4,5-b]pyridin-2-yl}cpyridin-2-amine bis-mesylate

4, 5 dibromorhodamine methyl ester

Theralux Photodynamic Therapy


Kiadis Pharma Canada, Inc.

4, 5 dibromorhodamine methyl ester




4,5 dibromorhodamine methyl ester


For immune reconstitution and prevention of graft versus host disease following allogeneic hematopoietic stem cell transplantation.

Kiadis Pharma Netherlands B.V.

4,5,6,7-tetrachloro-2',4',5',7'-tetraiodofluorescein disodium salt


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4,5,6,7-tetrahydroisoxazolo(5,4-c)pyridin-3-ol

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Treatment of Chronic Functional Vomiting to include functional vomiting and cyclic vomiting syndrome.

Dynogen Pharmaceuticals, Inc.

4-(3-Methanesulfonyl-phenyl)-1-propylpiperidine HCl


Teva Branded Pharmaceutical Products R&D

4-(4-Methoxy-phenylamino)-6-methylcarbamyl-quinoline-3-carboxylic acid

Prevention of scarring post ab externo glaucoma surgery

4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide

Treatment of diffuse large B-cell lymphoma.

4-(6-(4-(piperazin-1-yl)phenyl_pyrazolo[1,5-a]pyrimidin-3-yl)quinoline hydrochloride

Treatment of fibrodysplasia ossificans progressiva


4-(pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one

Treatment of congenital long QT syndrome


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n/a 8/22/2007194

4-Aminopyridine n/a 12/14/2005195

4-aminosalicylic acid 12/13/1989 Beeken, Warren M.D.196

4-aminosalicylic acid Paser Granules 4/26/2006197

n/a 7/20/2006198

n/a 9/29/2015

4-amino-1-[(1S,4R,5S)-2-fluoro-4,5-dihydroxy-3-(hydroxymethyl) cyclopent-2-en-1-yl] pyrimidin-2-one

Rexahn Pharmaceuticals, Inc.

4-Amino-1-[5-O-[(2R, 4S)-2-oxido-4-(4-pyridinyl)-1, 3, 2-dioxaphosphorinan-2-yl]-b-D-arabinofuranosyl]-2(1H)-pyrimidinone


Ligand Pharmaceuticals, Inc.

Treatment chronic functional motor and sensory deficits from Guillain-Barre syndrome

Acorda Therapeutics, Inc.

Pamisyl (P-D), Rezipas (Squibb)

Treatment of mild to moderate ulcerative colitis in patients intolerant to sulfasalazine.

Treatment of acute flares in pediatric patients with ileo-cecal Crohn's disease

Jacobus Pharmaceutical Co., Inc.

4-cyano-N-[2-(1-cyclohexen-1-yl)-4-[1-[dimethylamino)acetyl]-4-piperidinyl]phenyl]-1H-imidazole-2-carboxamide monohydrochloride


Johnson & Johnson Pharmaceutical Research & Dev,

4-Hydroxy-2,2,6,6-tetramethylpiperidine-N-oxyl

Treatment of cerebral cavernous malformation.

REcursion Pharmaceuticals, LLC


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Apogee Biotechnology Corporation

4-[(2E)-1-Oxo-3-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2-propen-1-yl]-1-piperazinecarboxamide


4-[(7-Methoxy-2,3-dihydro-1,4-benzothiazepin-4(5H)-yl)methyl]benzoic acid, hemifumarate

Treatment of patients with Duchenne Muscular Dystrophy.

Therapeia GmbH & Co KG

4-[1]benzofuro[3,2-d]pyrimidin-4-yl-N-(1,3-benzodioxol-5-ylmethyl)piperazine-1-carbothioamide

Treatment, in combination with radiotherapy and temozolomide chemotherapy, of patients with glioblastoma multiforme.

4-[2-(3-Propyl-[1,2,4]0xadiazol-5-yl)-vinyl]-benzene-1,2-diol

Treatment of chronic myeloid leukemia

Piramal Enterprises Limited

4-[4-[[[[3-(1,1-dimethylethyl)-1-(6-quinolinyl)-1H-pyrazol-5-yl]amino]carbonyl]-amino]-3-fluorophenoxyl]-N-methyl-2-pyridinecarboxamide, p-toluenesulfonate salt

Treatment of Philadelphia chromosome positive chronic myeloid leukemia

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4-[[9-(3S)-tetrahydro-3-furanyl]-8-[(2,4,6-trifluorophenyl)amino]-9H-purin-2-yl]amino]-trans-cyclohexanol


4-{[(2R,3S,4R,5S)-4-(4-Chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid

Treatment of Acute Myeloid Leukemia

40K PEGylated recombinant factor IX

Routine prophylactic administration for prevention of bleeding in patients with hemophilia B (Christmas disease)

5'-CTATCTGUC*G1TTCTCTGU-3'.17 Na+


Idera Pharmaceuticals, Inc.

Prophylaxis for patients following documented or suspected exposure to ebolavirus

Sarepta Therapeutics, Inc.

5(S)-(2'-hydroxy ethoxy)-20(S)-Camptothecin

Treatment of osteosarcoma (bone cancer)

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5,5',5"-[Phosphinothioylidyne-tris(imino-2,1-ethanediyl)]tris[5-methylchelidoninium]trihydroide hexahydrochloride

Treatment of malignant mesothelioma.

5,7-dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride

Treatment of Huntington's disease

Prana Biotechnology Limited

5,7-dihydroxy-3-(4-hydroxyphenyl)-chromen-4-one

Prevention of acute radiation syndrome

Humanetics Corporation

5-(3-ethyl-1,2,4-oxadiazol-5-yl)-1,4,5,6-tetrahydropyrimidine hydrochloride

Treatment of progressive supranuclear palsy.

5-(4,6-dimorpholino-1,3,5-triazin-2-yl)-4-(trifluoromethyl)-pyridin-2-amine

Treatment of primary central nervous system lymphoma.

PIQUR Therapeutics AG

5-(4-Cyclopropyl-1H-imidazol-l-yl)-2-fluoro-N-(6-(4-isopropyl-4H-1,2,4-triazol-3-yl)pyridin-2-yl)-4-methylbenzamide

Treatment pulmonary arterial hypertension

5-(ethylsulfonyl)-2-(naphthalen-2-yl)benzp[d]oxazole

Treatment of Duchenne Muscular Dystrophy

Summit Corporation plc


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5-aminolevulinic acid Gliolan 1/15/2013221

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n/a 5/26/2006 Treatment of sickle cell disease Baxalta US, Inc.223

n/a 12/31/2015 Treatment of soft tissue sarcoma224

n/a 5/26/2006 Treatment of malginant glioma Hana Biosciences, Inc.225

Resveratrol 3/13/2008 Treatment of MELAS syndrome226

n/a 8/25/2009 CureSMA227

n/a 10/31/2012228

n/a 11/3/2016 Treatment of Rett syndrome

Visualization of malignant tissue during surgery for malignant glioma (WHO garde III and IV)

NX Development Corporation

5-hydroxymethyl-2-furfuraldehyde

5-imino-13-deoxydoxorubicin HCl

Gem Pharmaceuticals, LLC

5-iodo-2-pytimidinone-2'-deoxyribose

5-[(E)-2-(4-hydroxyphenyl)-ethenyl] benzene-1,3 diol

Sirtris Pharmaceuticals, Inc.

5-[1-(2,6-Dichlorobenzyl)-piperidin-4-yl]methoxyquinazoline-2,4-diamine

Treatment of spinal muscular atrophy

5Ã¿Â¿Ã¿Ã¿Ã¿Â¢Ã¿Â¿Ã¿Ã¿Â¬"-GAATATTAACAIACTGACAAGTC-3Ã¿Â¿Ã¿Ã¿Ã¿Â¢Ã¿Â¿Ã¿Ã¿Â¬"

Prophylaxis following documented or suspected exposure to marburg virus


6'-(R)-Methyl-5-O-(5-amino-5,6-dideoxy-a-L-talofuranosyl)- paromamine sulfate

Eloxx Pharmaceuticals, Ltd.


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n/a 9/4/2014 Treatment of sickle cell disease Pfizer, Inc.233

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6,8-bis-benzylsulfanyl-octanoic acid

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6-((3S,4S)-4-Methyl-1-pyrimidin-2-ylmethyl-pyrrolidin-3-yl-1-(tetrahydro-pyran-4-yl)-1,5-dihydro-pryazolo[3,4-d]pyrimidin-4-one

6-(1H-Indazol-6-yl)-N-(4-morpholinophenyl)imidazo-[1,2-alpha]pyrazin-8-amine bis-methanesulfonate

Treatment of chronic lymphocytic leukemia

6-(4-(4-(2,3-dichlorophenyl)-piperazin-1-yl)-butoxy)-2H-benzo[b][1,4]oxazin-3(4H)-one hydrochloride

Treatment of pulmonary arterial hypertension (WHO Group 1)

Reviva Pharmaceuticals, Inc.

6-(R)-Methyl-5-O-(5-amino-5,6-dideoxy-a-L-talofuranosyl)- paromamine sulfate

Treatment of mucopolysaccharidosis type 1 (MPS I)

Eloxx Pharmaceuticals, Ltd.


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6-mercaptopurine oral liquid n/a 12/7/2009 Orbona Pharma Ltd241

n/a 5/11/2016242


n/a 2/11/2016

6-alpha-ethylchenodeoxycholic acid


Intercept Pharmaceuticals, Inc.

6-amino-5-chloro-N-[1R)-1-[5-[[[5-hloro-4-(trifluoromethyl)-2pyridinyl]amino]carbonyl]-2-thiazoyl]ethyl]-4-pyrimdinecarboxamide

Treatment of stage IIb-IV melanoma


6-ethoxy-7-methoxy-2-(2-methylsulfanylphenyl)-3,1-bensoxazin-4-one

Treatment of Netherton syndrome

6-fluoro-(18F)-L-3,4-dihydroxyphenylalanine

A diagnostic for management of patients with Lesch-Nyhan syndrome


Treatment of acute lymphoblastic leukemia in the pediatric population

6-methoxy-3-(3',4',5'-trimethoxybenzoyl) indole

Treatment of cholangiocarcinoma

SynCore Biotechnology Co. Ltd.

6-[4-Deoxy-4-[(2E,4E)-tetradecadienoylglycyl]amino-L-glycero-B-L-manno-heptopyranosyl]amino-9H-purine

DARA BioSciences, Inc.

6-{4-[l-(propan-2-yl)piperidin-4-yl]-1,4-diazepan-1-yl}-N-(pyridin-4-yl)pyridine-2-carboxamide

Treatment of glioblastoma multiforme (GBM).

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6-{[(1S)-1-phenylethyl]amino}-3-(propan-2-yl)-1,2,3,4 tetrahydropyrimidine-2,4-dione

Treatment of symptomatic obstructive hypertrophic cardiomyopathy

68G-OPS202, small somatostatin analog labeled with 68Gallium

Management of gastroenteropancreatic neuroendocrine tumors.

Ipsen Biosciences, Inc.

7-B-Hydroxy Cholesteryl-3-B-Oleate-Ester

7-benzyl-4-(2-methylbenzyl)-1,2,6,7,8,9-hexahydroimidazo[1,2-a]pyrido[3,4-e]pyrimidin-5(4H)-one*2HCl

7-ethyl-10-hydroxycamptothecin (EHC)


Nippon Kayaku Co., Ltd.

8-(1-Hydroxy-ethyl)-2-methoxy-3-(4-methoxy-benzyloxy)-benzo[c]chromen-6-one

Treatment of glioblastoma multiforme

Diffusion Pharmaceuticals, Inc.

For use in conjunction with the UVAR photopheresis to treat diffuse systemic sclerosis.

8-[4-(1-aminocyclobutyl)phenyl]-9-phenyl-1,2,4-triazolo[3,4-f][1,6]naph-thyrin-3(2H)-one mono-hydrochloride

Merck Sharp & Dohme Corp.


of 400



252

n/a 8/29/2016253

n/a 5/23/2016 Treatment of Friedreich's Ataxia Retroitope, Inc.254

9-nitro-20-(S)-camptothecin Camvirex 5/15/2001255

9-nitro-20-(S)-camptothecin n/a 9/16/1996 Treatment of pancreatic cancer. SuperGen, Inc.256

90Y-DOTA-tyr3-Octreotide n/a 1/20/2016257

90Y-hPAMA4 Pan-Cide 1/29/2004 Treatment of pancreatic cancer Immunomedics, Inc.258

n/a 4/29/2014 Advaxis, Inc.259

A-dmDT390-bisFv(UCHT1) Resimmune 10/9/2014 Angimmune, LLC260

a-Galactosidase A 1/21/2003 Treatment of Fabry's disease iBio, Inc.261

A10 & AS2-1 Antineoplaston n/a 9/3/2004

9,10-dimethoxy-5,6-dihydro-[1,3] dioxolo[4,5-g]isoquinolino[3,2-alpha]isoquinolin-7-ium(R)-4-((3R,5S,7S,8R,9S,10S,13R,14S,17R)-3,7-dihydroxy-10,13-dimethyhexadecahydro-1H-cyclopenta[alpha]


HighTide Biopharma Pty. Ltd.

9-cis, 12-cis-11,11-d2-linoleic acid ethyl ester

Treatment of pediatric HIV infection/AIDS

NovoMed Pharmaceuticals, Inc.

Treatment of neuroendocrine tumors

M. Sue O'Dorisio, MD, PhD

a live attenuated bioengineered Listeria monocytogenes cancer immunotherapy

Treatment of Stage II to IV invasive cervical carcinoma

Treatment of cutaneous T-cell lymphoma

Plant-Produced Human A-Glactosidase A

Treatment for patients with brain stem glioma

Burzynski Research Institute, Inc.


of 400



262

n/a 9/12/2013263

AAV-G6Pase vector n/a 3/11/2013264

abatacept Orencia 5/30/2013 Orban Biotech LLC265

ABCA4 DNA nanoparticles n/a 10/28/2015266

n/a 4/18/2011 Cortice Biosciences267

n/a 10/7/2011 Treatment of gliomas Cortice Biosciences268

Abetimus n/a 7/28/2000 Treatment of lupus nephritis.269

n/a 4/20/2014270

acadesine n/a 5/4/2011 Treatment of multiple myeloma

aadeno-associated viral vector, serotype 2, containing the human choroideremia gene encoding human Rab escort protein 1

Treatment of choroideremia due to mutations in the human choroideremia gene (CHM)

Sparks Therapeutics, Inc.

Treatment of glycogen storage disease type Ia

GlyGenix Therapeutics, Inc.

Treatment of type 1 diabetes mellitus patients with residual beta cell function

Treatment of Stargardt Macular Degeneration

Copernicus Therapeutics, Inc.

abeotaxane inhibitor of microtubules

Treatment of pediatric neuroblastoma.

abeotaxane inhibitor of microtubules

La Jolla Pharmaceutical Co.

Ac-Ile-Cys-Val-Trp(1-Me)-Gln-Asp-Trp-Gly-Ala-His-Arg-Cys-Thr-AEEA-Lys-PEG 40KDa-Lys-AEEA-Thr-Cys-Arg-His-ALa-Gly-Trp-Asp-Gln-(1-Me)Trp-Val-Cys-Ile-Ac

Treatment of paroxysmal nocturnal hemoglobinuria

Apellis Pharmaceuticals, Inc.

Advancell-Advanced In Vitro Cell Technologies S.A.


of 400



271

acadesine n/a 3/3/2011272

acamprosate n/a 3/25/2013 Treatment of fragile X syndrome273

aceneuramic acid n/a 9/23/2011274

n/a 11/24/2015 Genus Oncology, LLC275

acetyl-l-carnitine n/a 7/24/2012 Treatment of Fragile X syndrome276

acetyl-l-carnitine (ALC) n/a 3/18/2011 Treatment of Rett syndrome277

Acetylcysteine 8/13/1987278

ActRIIB-IgG1) n/a 8/16/2010


Avanced In Vitro Cell Technologies, S.L.

Confluence Pharmaceuticals, LLC

Treatment of hereditary inclusion body myopathy

Ultragenyx Pharmaceutical, Inc.

acetyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-arginyl-D-cysteinyl-D-glutaminyl-D-cystenyl-D-arginyl-D-arginyl-D-lysyl-D-asparaginylmaide disulfide




Mucomyst/Mucomyst 10 Iv

Intravenous treatment of patients presenting with moderate to severe acetaminophen overdose.


Treatment of Duchenne muscular dystrophy

Acceleron Pharma, Inc.


of 400



279

acyclovir n/a 5/3/2016 Treatment of herpetic keratitis.280

acyclovir n/a 12/13/2010 Fera Pharmaceuticals281

n/a 3/17/2014 Treatment of ovarian cancer Oncos Therapeutics282

adalimumab Humira 5/11/2011 AbbVie, Inc.283

adalimumab n/a 7/10/2014 Treatment of Behcet's disease Mucora284

n/a 9/29/2015 REGENXBIO, Inc.285

n/a 3/17/2011 Fondazione Telethon286

n/a 5/6/2013 Lysogene

Cumulus Pharmaceuticals LLC

Treatment of acute herpetic keratitis caused by Herpes Simplex Virus type 1 and 2

Ad5/3-D24-granulocyte-macrophage colony stimulating factor (GMCSF)-encoding oncolytic adenovirus

Treatment of pediatric patients with ulcerative colitis

aden-associated virus vector serotype 9 expressing human a-L-iduronidase

Treatment of mucopolysaccharidosis Type I (MSP I).

adeno associated viral vector containing human ARSB gene

Treatment of mucopolysaccharidosis type VI (MPS VI; Maroteaux-Lamy syndrome)

adeno associated viral vector serotype rh.10 carrying the human SGSH and SUMF1 cDNAs

Treatment of mucopolysaccharidosis type IIIA (Sanfilippo type A syndrome)


of 400



287

n/a 3/14/2014 Treatment of hemophilia B Baxalta US, Inc.288

n/a 5/21/2007 uniQure B.V.289

n/a 11/18/2015 LYSOGENE290

n/a 3/16/2016291

n/a 9/21/2015 Treatment of hemophilia B.

adeno associated virus with modified transthyretin and sequence encoding factor IX variant gene

Adeno-associated vector expressing the human lipoprotein lipase protein

Treatment of lipoprotein lipase deficiency

adeno-associated viral (AAV) vector serotype rh. 10 encoding the human N-sulfoglycosamine sulphohydrolase cDNA (SGSH)

Treatment of mucopolysaccharidosis type IIIA or Sanfilippo type A syndrome

adeno-associated viral serotype 2 vector under the regulatory control of a CMV promoter encoding the human tripeptidyl peptidase-1 (hTPP1) cDNA

Treatment of CLN2 disease (neuronal ceroid lipofuscinosis (NCL)) caused by TPP1 deficiency.

Spark Therapeutics, Inc.

adeno-associated viral vector composed of a bioengineered AAV capsid and a codon-optimized expression cassette encoding a high-specific activity variant of human coagulation factor IX



of 400



292

n/a 12/13/2012 treatment of retinitis pigmentosa293

n/a 9/15/2010 uniQure B.V.294

Coagulin-B 6/13/2001 Avigen, Inc.295

Coagulin-B 6/13/2001 Avigen, Inc.296

n/a 11/20/2013 Gen Sight Biologics297

n/a 8/31/2016 Solid GT, LLC

adeno-associated viral vector containing DNA encoding an RNAi targeting rhodopsin in combination with an adeno-associated viral vector containing DNA encoding a rhodopsin gene

Genable Technologies Limited

adeno-associated viral vector containing modified U11 snRNA

Treatment of Duchenne muscular dystrophy.

Adeno-associated viral vector containing the gene for human coagulation factor IX

Intrahepatic treatment of patients with moderate to severe hemophilia

Adeno-associated viral vector containing the gene for human coagulation factor IX

Intramuscular treatment of patients with moderate to severe hemophilia

adeno-associated viral vector containing the human NADH Dehydrogenase 4 Gene

Treatment of Leber Hereditary Optic Neuropathy

Adeno-associated viral vector differentially expressing microdystrophin 5 gene via the muscle-specific promoter CK8.



of 400



298

n/a 3/20/2007 Treatment of Pompe disease299

n/a 5/21/2007300

n/a 1/31/2012301

n/a 12/31/2015302

n/a 11/5/2014 Treatment of choroideremia NightstaRx Ltd.303

n/a 12/27/2012304

Calmarythm 10/2/2014

Adeno-associated viral vector expressing human acid alpha glucosidase gene

Audentes Therapeutics, Inc.

adeno-associated viral vector expressing human retinoschisin-1 gene

Treatment of X-linked juvenile retinoschisis (XLRS).

Applied Genetic Technologies Corporation

Adeno-Associated Viral Vector Expressing Low-Density Lipoprotein Receptor

Treatment of homozygous familial hypercholesterolemia

ReGenX Biosciences LLC

adeno-associated viral vector expressing the human vascular endothelial growth factor gene

Treatment of critical limb ischemia in no-option patients where other procedures, grafts, or angioplasty are not indicated

Integene International Holding, LLC

adeno-associated viral vector serotype 2 containing the human Rab escort protein 1 gene

adeno-associated viral vector serotype 9 containing human N-acetylglucosaminidase alpha gene

Treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome)

Laboratorios del Dr. Esteve, S.A.

adeno-associated viral vector serotype 9 containing the human cardiac calsequestrin gene

Treatment of catecholaminergic polymorphic ventricular tachycardia



of 400



305

n/a 3/18/2015306

n/a 9/19/2016 Milo Biotechnology307

n/a 9/1/2016 Treatment of hemophilia B308

n/a 9/30/2014 AveXis, Inc.309

n/a 7/16/2015310

n/a 8/25/2015 Treatment of hemophilia B.311

n/a 11/19/2012 Milo Biotechnology

adeno-associated viral vector type 2 expressing human recombinant retinal pigment epithelial 65KDa protein gene

Treatment of inherited retinal dystrophy due to biallelic RPE65 gene mutations


Adeno-associated virus delivered transgene of follistatin

Treatment of inclusion body myositis

Adeno-associated virus serotype 2/6 (rAAV2/6) vectors encoding zinc finger nucleases (ZFNs) and human factor 9 gene (SB-FIX)

Sangamo BioSciences, Inc.

adeno-associated virus serotype 9 expressing the human Survival Motor Neuron gene


adeno-associated virus serotype 9 vector containing human Iduronate-2-sulfatase transgene

Treatment of mucopolysaccharidosis type II (Hunter syndrome).


Adeno-associated virus serotype rh10 vector encoding the human factor IX gene

Dimension Therapeutics

adeno-associated virus transgene of follistatin

Treatment of Duchennes and Becker's muscular dystrophy


of 400



312

n/a 11/16/2015313

n/a 2/29/2016 Treatment of Hemophilia A.314

n/a 6/1/2011315

n/a 9/4/2014316

n/a 3/3/2011 Eli Lilly and Company

adeno-associated virus type 8 delivering a vector genome with human retinoschisin promoter (RS/IRBP) and the human retinoschisin cDNA (hRS)

Treatment of X-linked retinoschisis

Paul A. Sievig, MD, PhD, National Eye Institute, NIH

adeno-associated virus vector encoding the SQ variant of human blood clotting factor VIII

BioMarin Pharmaceutical, Inc.

adeno-associated virus vector serotype 9 expressing human sulfamidase

Treatment of mucopolysaccharidosis type IIIA (Sanfilippo A Syndrome).


Adenoassociated virus vector (AAV) carrying a modified AAV serotype 2 backbone and coding sequence of human thymidine phosphorylase preceded by a human thyroxin-binding globulin promoter

For the treatment of Mitochondrial Neurogastrointestinal Encephalomyopathy (MNGIE)

Columbia University Medical Center

Adenosine triphosphate type 1 competitive inhibitor of JAK2 V617F tyrosine kinase

Treatment of myeloproliferative disorders (polycythemia vera, essential throbocythemia, and myelofibrosis)


of 400



317

n/a 6/17/2005 Advantagene, Inc.318

n/a 6/8/2015319

n/a 7/23/2015 Treatment of malignant glioma.320

n/a 3/10/2016 MeiraGTx Limited321



n/a 4/2/2012 Treatment of malignant glioma Vascular Biogenics Ltd324

n/a 10/1/2014 Treatment of glioma DNAtrix, Inc.

Adenoviral vector expressing Herpes simplex virus thymidine kinase gene

Treatment of malignant brain tumors

adenoviral vector expressing the E.coli purine nucleoside phosphorylase gene and fludarabine

Intratumoral treatment of anatomically accessible oral and pharyngeal cancers (lip, tongue, gum, floor of mouth, salivary gland, and other oral cavity)

PNP Therapeutics, Inc.

Adenoviral vector-RheoSwitch Therapeutic System-human interleukin 12 + veledimex

Ziopharm Oncology, Inc.

adenovirus associated viral vector serotype 5 containing the human RPE65 gene

Treatment of Leber congenital amaurosis

adenovirus associated viral vector serotype 5 containing the RPGR gene


adenovirus associated viral vector serotype 8 containing the human CNGB3 gene

Treatment of achromatopsia due to mutations in the CNGB3 gene.

adenovirus containing a human FAS-c gene

adenovirus delta 24-RGD, an oncolytic adenovirus genetically modified for treatment of glioma


of 400



325n/a 4/19/2016 Memgen LLC

326

n/a 9/4/2014 Etubics Corporation327

n/a 7/14/2015 Treatment of mesothelioma MTG Biotherapeutics328

n/a 7/5/2016 HORAMA, SAS329

Miniadfviii 12/15/1999 Treatment of hemophilia A.330

Multistem 7/6/2012 Athersys, Inc.331

n/a 5/27/2015 Treatment of aplastic anemia HemoGenyx LLC332

ADXS11-001 n/a 8/12/2013 Advaxis, Inc.333

aerosolized beractant n/a 3/11/2013334

n/a 4/30/2010 Treatment of ovarian cancer Aeterna Zentaris

Adenovirus encoding the recombinant CD40 ligand

Treatment of stage IIb through IV melanoma.

Adenovirus serotype-5 (Ad5) vector that contains a modified non-oncogenic fused early 6 (E6) and early 7 (E7) gene of the human papillomavirus (HPV); (Ad5 [E1-, E2b-]-E6/E7)

Treatment of human papillomavirus (HPV)-associated head and neck squamous cell carcinoma (HNSCC)

adenovirus vaccine encoding reduced expression in immortalized cell protein

adenovirus-associated viral vector serotype 5 containing the human pde6B gene

Treatment of retinitis pigmentosa due to pde6B gene mutations

Adenovirus-based vector Factor VIII complementary DNA to somatic cells

GenStar Therapeutics Corporation

adult adherent bone marrow-derived multipotent stem cells

Treatment of MPS-1, including Hurler syndrome

adult hemogenic endothelial cells

Treatment of HPV-positive associated anal cancer

Treatment of respiratory distress syndrome

Beena G. Sood, MD, MS

AEZS-108 (LHRH-agonist linked to doxorubicin)


of 400



335afamelanotide n/a 7/17/2008 Clinuvel Inc.

336 afamelanotide n/a 12/11/2009 Treatment of solar urticaria Clinuvel, Inc.337

afamelanotide n/a 5/14/2014 Clinuvel, Inc.338

afamelanotide n/a 2/4/2016 Clinuvel Inc.339

afatinib Gilotrif(R) 6/4/2014340

aganirsen n/a 11/7/2016341

Albuterol n/a 3/12/2002 MotoGen, Inc.342

Aldesleukin Proleukin 11/24/1998343

Aldesleukin Proleukin 3/22/1989344 aldoxorubicin n/a 9/24/2014 Treatment of ovarian cancer CytRx Corporation345

aldoxorubicin n/a 9/24/2014 CytRx Corporation346

aldoxorubicin n/a 9/24/2014 CytRx Corporation

Treatment of erythropoietic porphyrias

Treatment of familial benign chronic pemphigus (Hailey-Hailey disease)

Treatment of cutaneous variants of porphyria (which includes treatment and prevention of cutaneous manifestations of disease)

Treatment of malignant brain and central nervous system tumors

Boehringer Ingelheim Pharmaceuticals, Inc.

Prevention of corneal graft rejection.

Gene Signal International SA

Prevention of paralysis due to spinal cord injury

For the treatment non-Hodgkin's lymphoma.

Prometheus Laboratories, Inc.

Treatment of primary immunodeficiency disease associated with T-cell defects.

Prometheus Laboratories, Inc.


Treatment of small cell lung cancer


of 400



347

Alendronate disodium Fosamax 2/13/2001348

Alfentanil n/a 7/8/2005 Cinergen, LLC349

Alfentanil n/a 8/9/2005 Cinergen, LLC350

alfimeprase n/a 9/20/2012351

algenpantucel-L 10/21/2010 Treatment of pancreatic cancer.352

Alglucerase injection Ceredase 7/21/1995 Genzyme Corporation353

alicaforsen n/a 6/24/2008 Treatment of pouchitis.354

alisertib n/a 7/12/2013355

Alitretinoin Panretin 4/10/1992356

Retriacyl 5/21/2014 Natac Pharma, S.L.

Treatment of the bone manifestations of Gaucher disease

Richard J. Wenstrup, M.D.

Management of postherpetic neuralgia

Treatment of painful HIV-associated neuropathy

Treatment of ST-elevation myocardial infarcted patients who are undergoing primary percutaneous coronary intervention

Niche Therapeutics, LLC

Hyperacute(R)-Pancreatic Cance

NewLink Genetics Corporation

Replacement therapy in patients with Type II and III Gaucher's disease.

Atlantic Healthcare Limited



Treatment of acute promyelocytic leukemia

Ligand Pharmaceuticals, Inc.

all-cis-docosa-4,7,10,13,16,19-hexaenoic acid



of 400



357

allantoin Alwextin 11/21/2002 Scioderm, Inc.358

n/a 4/21/2015 Capricor, Inc.359

n/a 12/2/2010360

n/a 2/4/2016361

n/a 2/18/2013 Treatment of Aplastic Anemia362

n/a 12/29/2015363

n/a 8/22/2011

Treatment of skin blistering and erosions associated with inherited epidermolysis bullosa

allogeneic cardiosphere-derived cells


allogeneic cord blood cells, ex vivo modulated with 16,16 dimethyl prostaglandin E2 (dmPGE2)

Enhancement of stem cell engraftment through ex vivo treatment of human allogeneic hematopoietic stem cells (treatment of neuropenia, thrombocytopenia, lymphopenia, and anemia).

Fate Therapeutics, Inc.

allogeneic Epstein-Barr virus cytotoxic T lymphocytes

Treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disorders.

ATARA Biotherapeutics, Inc.

allogeneic ex-vivo expanded placental adherent stromal cells

Pluristem Therapeutics, Inc.


For the treatment of severe preeclampsia

Pluristem Therapeutics, Inc


Treatment of thromboangiitis obliterans (Buerger's disease)

Pluristem Therapeutics, Inc.


of 400



364

n/a 4/20/2016 IPD-Therapeutics BV365

Atir 2/2/2010366

Vascugel (R) 4/3/2009 Shire367

Motorgraft (Tm) 1/17/2014 Caladrius Biosciences368

Cytoimplant 6/13/1997 Treatment of pancreatic cancer

allogeneic ex-vivo generated CD56+CD3-natural killer cells from CD34+ umbilical cord blood progenitor cells


allogeneic hematopoietic stem cell

Prevention (reduction) of transplant related mortality (TRM, which is caused by graft versus host disease and/or infections) following mismatched (haploidentical) allogeneic hematopoietic stem cell transplantation.

Kiadis Pharma Netherlands B.V.

Allogeneic human aortic endothelial cells cultured in a porcine gelatin matrix

Prevention of arteriovenous fistula or arteriovenous graft failure in patients with end satge renal disease receiving hemodialysis or preparing for hemodialysis

Allogeneic motor neuron progenitor cells derived from human embryonic stem cells

Treatment of Amyotrophic Lateral Sclerosis

Allogeneic peripheral blood mononuclear cells sensitized against patient alloantigens by mixed lymphocyte culture

Applied Immunotherapeutics, LLC


of 400



369

n/a 9/1/2004 Neurotech USA, Inc.370

n/a 1/28/2005 MolMed S.p.A.371

n/a 7/24/2012 Neurotech USA, Inc.372

allopregnanolone n/a 7/12/2013373

allopregnanolone n/a 4/20/2014 Treatment of status epilepticus Sage Therapeutics374

n/a 3/24/2015375

alpha melanotropin n/a 9/2/2010

Allogeneic retinal epithelial cells transfected with plasmid vector expressing ciliary neurotrophic growth factor


Allogeneic T-cells cultured with anti-CD3 and IL-2; transduced with retroviral vector (SFCMM-3), expressing herpes simplex 1 virus-thymidine kinase (HSV-TK) and truncated low affinity nerve growth factor receptor; selected with anti-low affinity nerve gro

Immunotherapy for acceleration of T-cell reconstitution in patients undergoing allogeneic hematopoietic stem cell transplantation

allogenic retinal epithelial cells transfected with plasmid vector expressing ciliary neurotrophic growth factor

Treatment of macular telangiectasia type 2 (MacTel)

Treatment of Neimann-Pick disease, type C


allosteric activator of the red blood cell-specific form of pyruvate kinase

Treatment of pyruvate kinase deficiency

Agios Pharmaceuticals, Inc.

Treatment of chronic beryllium disease

mondoBIOTECH Laboratories AG


of 400



376Glassia 10/23/2014 Kamada Ltd.

377Glassia 7/28/2011 Kamada, Ltd.

378

Alpha-galactosidase A Cc-Galactosidase 6/17/1991 David Calhoun, Ph.D.379

Alpha-galactosidase A Fabrase 7/20/1990 Treatment of Fabry's disease.380

Alpha-galactosidase A Replagal 6/22/1998381

n/a 8/19/1997382

Alpha-tocopherol quinone n/a 3/28/2006383

alpha-tocotrienol quinone n/a 10/21/2010384

n/a 1/29/2010385 Alpha1-antitrypsin(human) n/a 4/3/2008 Treatment of bronchiectasis Kamada Ltd.386

n/a 2/20/2009 Treatment of cystic fibrosis CSL Behring LLC387

n/a 4/6/2012 Treatment of cystic fibrosis

alpha-1 proteinase inhibitor (human)

Treatment of graft versus host disease

alpha-1 proteinase inhibitor (human)

Treatment of patients with recent onset (

Treatment of alpha-galactosidase A deficiency (Fabry's disease).

Desnick, Robert J. M.D.

Long-term enzyme replacement therapy for the treatment of Fabry disease


Alpha-melanocyte stimulating hormone

Prevention and treatment of intrinsic acute renal failure due to ischemia.

National Institute of Diabetes, and Digestive and Kidney Diseases

Treatment of inherited mitochondrial respiratory chain diseases

Penwest Pharmaceuticals Company

Treatment of inherited mitochondrial respiratory chain diseases.

Edison pharmaceuticals, Inc.

alpha1 proteinase inhibitor (human)

Treatment of emphysema secondary to congenital alpha1-antitrypsin deficiency.

Grifols Therapeutics, Inc.

alpha1-proteinase inhibitor (human)




of 400



388

Prolastin(R)-C 3/3/2015389

n/a 12/22/2004 Kamada Ltd.390

Arc-Api 9/1/2004 Treatment of cystic fibrosis Kamada Ltd.391

alteplase Activase 1/27/2003 Daniel F. Hanley, MD392

altiratinib n/a 8/19/2014393

alvocidib n/a 4/21/2014394

Alvocidib n/a 4/13/2007395

Amantadine HCl n/a 7/20/2015396

Amantadine hydrochloride Nurelin 4/9/2015397 amatuximab n/a 9/28/2012 Treatment of mesothelioma Morphotek, Inc.398

n/a 8/22/2016 Gilead Sciences, Inc.


Treatment of Type 1 diabetes mellitus patients with residual beta-cell function.


Alpha1-Proteinase Inhibitor (Human)

Inhalation therapy for the treatment of congential deficiency of alpha1-proteinase inhibitor.

Alpha1-Proteinase Inhibitor (Human)

Treatment of intraventricular hemorrhage associated with intracerebral hemorrhage




Tolero Pharmaceuticals, Inc.

Teatment of B-cell chronic lymphocytic leukemia (B-CLL) or prolymphocytic leukemia arising from CLL.

Tolero Pharmaceuticals, Inc.

Treatment of levodopa-induced dyskinesia

Osmotica Pharmaceutical Corporation

Treatment of levodopa-induced dyskinesia

Adamas Pharmaceuticals, Inc.

ambrisentan/tadalafil fixed combination



of 400



399ambroxol n/a 6/29/2011 Treatment of Gaucher disease Belrose Pharma, Inc.

400amifampridine phosphate n/a 3/3/2015

401

amifampridine phosphate n/a 11/12/2009402

amifampridine phosphate n/a 8/31/2016 Treatment of myasthenia gravis403

Amifostine Ethyol 11/24/1998 Clinigen Group plc404




amikacin sulfate n/a 1/5/2015 PlumeStars s.r.l.408

Aminocaproic acid Caprogel 1/6/1995

Treatment of congenital myasthenic syndromes

Catalyst Pharmaceuticals

Treatment of Lambert-Eaton Myasthenic Syndrome



For the reduction of the incidence and severity of toxicities associated with cisplatin administration.

Treatment of myelodysplastic syndromes.

For use as a chemoprotective agent for cyclophosphamide in the treatment of advanced ovarian carcinoma.

For use as a chemoprotective agent for cisplatin in the treatment of metastatic melanoma.

Management of cystic fibrosis patients with Pseudomonas aeruginosa lung infections

For the topical treatment of traumatic hyphema of the eye.

Eastern Virginia Medical School


of 400



409

Levulan 3/20/2007410

Aminosidine Paromomycin 9/9/1994411

Aminosidine Gabbromicina 11/15/1993412

Aminosidine Gabbromicina 5/14/1993 Treatment of tuberculosis.413

aminosidine Paromomycin 3/29/2005414

Amiodarone Amio-Aqueous 8/17/1993415

amitriptyline and ketamine Amiket(Tm) 1/19/2010416

n/a 5/5/2008417

Coprexa 1/31/1994 Treatment of Wilson's disease.418

amphotericin B n/a 9/15/2010 iCo Therapeutics Inc.

aminolevulinic acid hydrochloride

Treatment of esophageal dysplasia

DUSA Pharmaceuticals, Inc.

Treatment of visceral leishmaniasis (kala-azar).

Kanyok, Thomas P. Pharm.D.

Treatment of Mycobacterium avium complex.



Treatment of visceral leishmaniasis

The Institute for One World Health

Treatment of incessant ventricular tachycardia.

Academic Pharmaceuticals, Inc.

Treatment of postherpetic neuralgia

Immune Pharmaceuicals, Inc.

ammonium tetrathiomolybdate


Pipex Pharmaceuticals, Inc.

Ammonium tetrathiomolybdate

Pipex Pharmaceuticals, Inc.

Treatment of visceral leishmaniasis.


of 400



419

n/a 12/15/2005420

Cyanide Antidote Kit 12/18/2006 Treatment of cyanide poisoning Akorn, Inc.421

amylopectin n/a 3/24/2015422

n/a 12/22/2011 Treatment of hemophilia B uniQure, B.V.423

n/a 7/7/2015 Treatment of Ewing sarcoma424

Anagrelide Agrylin 7/14/1986425

Anagrelide Agrylin 6/11/1985 Treatment of polycythemia vera.426

Ananain, comosain Vianain 1/21/1992 Genzyme Corporation

Amphotericin B inhalation powder

Prevention of pulmonary fungal infections in patients at risk for aspergillosis due to immunosuppressive therapy including those receiving organ or stem cell transplants, or treated with chemotherapy or radiation for hematologic malignancies


Amyl nitrite, sodium nitrite, sodium thiosulfate

Treatment of glycogen storage disease types Ia and Ib

Michael K. Davis, MD, MBA

an adeno-associated viral vector containing a codon-optimised human factor IX gene (AAV5-hFIXco)

ANA-conjugated dactunomycin nanoemulsion

NanoSmart Pharmaceuticals, Inc.

Treatment of thrombocytosis in chronic myelogenous leukemia.

Roberts Pharmaceutical Corp.


For the enzymatic debridement of severe burns.


of 400



427

Anatibant n/a 4/15/2005 Xytis, Inc.428

Ancrod Viprinex 10/20/1989429

andexanet alfa n/a 2/23/2015430

anfibatide n/a 3/10/2016431

Angiotensin (1-7) n/a 2/8/2016 Tarix Orphan, LLC432

Angiotensin (1-7) n/a 9/1/2016 Tarix Orphan, LLC

Treatment of patients having experienced a severe traumatic brain injury (Glasgow Coma Scale 3 to 8) in order to decrease early mortality and improve long-term functional and neurological outcome

To establish and maintain anticoagulation in heparin-intolerant patients undergoing cardiopulmonary bypass.

Knoll Pharmaceutical Company

For reversing the anticoagulant effect of direct or indirect factor Xa inhibitors in patients experiencing a serious uncontrolled bleeding event or who require urgent or emergent surgery

Portola Pharmaceuticals

Treatment of thrombotic thrombocytopenic purpura.

Lee's Pharmaceutical (Hong Kong) Limited

Treatment of LAMA2-related muscular dystrophy

Treatment of recessive dystrophic epidermolysis bullosa (RDEB).


of 400



433Angiotensin (1-7) n/a 11/26/2013 US Biotest, Inc.

434

angiotensin (1-7) n/a 8/30/2013 US Biotest, Inc.435

angiotensin (1-7)[A(1-7)] n/a 7/25/2013 US Biotest, Inc.436

Angiotensin 1-7 n/a 2/16/2000437

angiotensin 1-7 n/a 1/29/2010 Treatment of sarcoma. W. Jeffrey Petty, MD438

Angiotensin 1-7 Marstem 8/3/2001439

angiotensin 1-7 n/a 6/17/2010 US Biotest, Inc.

Treatment of limb-girdle muscular dystrophy

Treatment of patients requiring stem cell transplantation to accelerate the mobilization of hematopoietic stem cells (CD34+) from the bone marrow to the peripheral blood when combined with a granulocyte colony-stimulating factor


Treatment of neutropenia associated with autologous bone marrow transplantation.

Maret Pharmaceuticals


Maret Pharmaceutical Corporation

To accelerate engraftment of hematopoietic cells (treatment of neutropenia, thrombocytopenia, lymphoma, and aneima)in hematopoietic stem cell transplants.


of 400



440Angiotensin-(1-7) n/a 9/13/2011 US Biotest, Inc.

441anisina n/a 7/14/2015 Treatment of neuroblastoma. Novogen Ltd

442anlotinib hydrochloride n/a 12/31/2015 Treatment of ovarian cancer

443n/a 11/17/2014 ChemoCentryx, Inc.

444

n/a 6/2/2014 ChemoCentryx, Inc.445

n/a 12/23/2014446

n/a 10/20/2008447

n/a 8/7/2014 Treatment of glioblastoma OncoSynergy, Inc.448

n/a 1/13/2015 Treatment of ovarian cancer OncoSynergy, Inc.449

n/a 9/13/2013 Xenikos BV

Treatment of pulmonary arterial hypertension.

Advenchen Laboratories, LLC

antagonist of the complement 5a receptor

Treatment of atypical hemolytic uremic syndrome

antagonist of the complement 5a receptor

Treatment of anti-neutrophil cytoplasmic autoantibodies associated vasculitides (granulomatosis with polyangiitis or Wegener's granulomatosis), microscopic polyangiitis, and Churg-Strauss syndrome.

antagonist of the endosomal Toll-like receptors (TLRs) 7, 8, and 9


Idera Pharmaceuticals, Inc.

anti human Nogo-A human monoclonal antibody

Treatment of acute spinal cord injury


Anti-Beta1 integrin monoclonal antibody

anti-Beta1 integrin monoclonal antibody

anti-CD3 mAb (SPV-T3a)-ricin A chain fusion protein and anti-CD7 mAb (WT1)-ricin A chain fusion protein



of 400



450

n/a 12/2/2008 Treatment of Hodgkin lymphoma Xencor, Inc.451

n/a 5/13/2015452

anti-HER2 bispecific antibody n/a 5/18/2016 Treatment of ovarian cancer Zymeworks Inc.453

n/a 7/6/2016 Treatment of ovarian cancer Zymeworks Inc.454

n/a 11/18/2003455

n/a 3/9/2012 Treament of ovarian cancer456



n/a 4/3/2009

anti-CD30 Fc engineered humanized monoclonal antibody

Anti-eTau Humanized IgG4 Monoclonal Antibody

Treatment of Progressive Supranuclear Palsy

Britol-Myers Squibb Company

anti-HER2 bispecific antibody drug conjugate

anti-interferon-gamma Fab from goats

For the treatment of immunologic corneal allograft rejection

Advanced Biotherapy, Inc.

anti-Lewis Y humanized monoclonal antibody

Recepta Biopharma S.A.

anti-sense oligonucleotide consisting of 2Ã¿Æ¿Ã¿â¿¿Ã¿â¿¿Ã¿Â¢Ã¿Æ¿Ã¿Â¢Ã¿Â¢Ã¢â¿¿Â¬Ã¿Â¡Ã¿â¿¿Ã¿Â¬Ã¿Æ¿Ã¿Â¢Ã¿Â¢Ã¢â¿¿Â¬Ã¿Â¾Ã¿â¿¿Ã¿Â¢0-Me RNA with a phosphorothioate backbone

ProQR Therapeutics III B.V.

anti-STAT3 (Signal Transducer and Activator of Transcription 3) B VHH13 single domain antibody

Singh Biotechnology, LLC

Anti-T cell receptor murine monoclonal antibody

Prophylaxis of acute rejection of solid organ transplantation

Tolera Therapeutics, Inc.


of 400



459

n/a 9/12/2008460

Atg-Fresenius(R) 3/26/2010461

n/a 1/12/2011462

n/a 6/7/2010463

Neuradiab 10/4/2005464

Thymoglobulin 5/25/2010 Genzyme Corporation465

Anti-thymocyte serum 6/2/1993466

n/a 11/17/2014467

Neovastat (Ae-941) 10/16/2002 AEterna Zentaris, Inc.

anti-T-lymphocyte immune globulin, rabbit

Prophylaxis of acute allograft rejection in adult recipients in solid organ transplantation

Neovii Biotech NA, Inc.

anti-T-lymphocyte immune globulin, rabbit

Prevention of graft versus host disease (GVHD)

Neovii Biotech NA, Inc.

anti-TCR murine monoclonal antibody (MAB, type IgM)

Treatment of pediatric multiple sclerosis in patients less than or equal to 16 years of age


anti-TCR murine monoclonal antibody (MAb, type IgM)

Treatment of patients 16 years of age and younger with immune-mediated T1DM and preserved pancreatic beta cell function


Anti-tenascin 81C6 monoclonal antibody labeled w/ I 131

Treatment of primary malignant brain tumors

Bradmer Pharmaceuticals, Inc.

anti-thymocyte globulin [rabbit]

Prophylaxis of acute organ rejection in patients receiving renal transplants

Nashville Rabbit Anti-Thymocyte Serum

Treatment of allograft rejection, including solid organ (kidney, liver, heart, lung, and pancreas) and bone marrow transplantation.

Applied Medical Research

anti-tumor necrosis factor (TNF) polyclonal antibody (bovine)

Treatment of pediatric ulcerative colitis (0 through 16 years of age)

Avaxia Biologics, Incorporated

antiangiogenic components extracted from marine cartilage



of 400



468

Antiepilepsirine n/a 3/23/1989 Children's Hospital469

n/a 7/5/2012 Treatment of mesothelioma470

n/a 11/21/2008 Treatment of gliomas471

n/a 2/3/2015 Treatment of Ewing's sarcoma.472

n/a 4/15/2005473

Gti-2040 3/12/2003

Treatment of drug resistant generalized tonic-clonic epilepsy in children and adults.

antimesothelin-ADC (antibody drug conjugate)

Bayer HealthCare Pharmaceuticals, Inc.

antineoplaston A10, antineoplaston AS2-1

Burzynski Research Institute, Inc.

antinuclear antibody conjugated liposomal doxorubicin

NanoSmart Pharmaceuticals, Inc.

Antisense 20-mer oligonucleotide complementary to R2 component of ribonucleotide reductase mRNA


Lorus Therapeutics, Inc.

antisense 20-mer phosphorothioate oligonucleotide [complementary to the coding region of R2 component of the human ribonucleotide reductase mRNA]

Treatment for renal cell carcinoma

Lorus Therapeutics, Inc


of 400



474

n/a 5/25/2016475

Nexagon 4/27/2009476

n/a 9/19/2016 Biogen477

n/a 7/24/2012478

n/a 12/29/2015479

n/a 6/16/2016 Wave LIfe Sciences

antisense oligonucleotide complementary to the exonic splicer enhancer sequence at intron 26 of the centrosomal protein 290 pre-mRNA

Treatment of Leber's congenital amaurosis.

ProQR Therapeutics IV B.V.

Antisense oligonucleotide directed against connexin43

Treatment of persistent corneal epithelial defects

CoDa Therapeutics, Inc.

antisense oligonucleotide inhibitor of the expression of superoxide dismutase 1 gene


antisense oligonucleotide targeted to human transthyretin (TTR) mRNA

Treatment of familial amyloid polyneuropathy

Isis Pharmaceuticals, Inc.

Antisense oligonucleotide targeted to the huntingtin protein


Isis Pharmaceuticals, Inc.

antisense oligonucleotide targeting the U isoform of SNP rs362307

Treatment of Huntington's disease (prodromal stage Huntington's disease and diagnosed Huntington's disease)


of 400



480

Antithrombin III human Antithrombin Iii Human 1/2/1986481

n/a 2/12/1991482

antroquinonol Hocena(R) 4/30/2015483

antroquinonol n/a 7/23/2015484

antroquinonol n/a 1/21/2015 Treatment of pancreatic cancer485

aphidicolin n/a 4/20/2016 Biospherics.net LLC486

n/a 12/3/2012

Preventing or arresting episodes of thrombosis in patients with congenital AT-III deficiency and/or to prevent the occurrence of thrombosis in patients with AT-III deficiency who have undergone trauma or who are about to undergo surgery or parturition.

American National Red Cross

Antivenom (crotalidae) purified (avian)

Treatment of envenomation by poisonous snakes belonging to the Crotalidae family.

Ophidian Pharmaceuticals, Inc.


Golden Biotechnology Corporation


Golden Biotechnology Corporation

Golden Biotechnology Corp.

Treatment of Ebola virus infection

apolipoprotein E mimetic peptide


LipimetiX Development, LLC


of 400



487

Apomorphine n/a 7/17/1995488

Apomorphine hydrochloride n/a 5/23/2006489

apremilast n/a 1/17/2013 Treatment of Behcet's disease Celgene Corporation490

n/a 9/12/2008 Treatment of malaria491

Arenegyr n/a 8/22/2008 MolMed S.p.A.492

Arginine butyrate n/a 4/7/1992493

arimoclomol n/a 3/29/2005 CytRx Corporation494

arimoclomol citrate n/a 1/13/2015 Orphazyme ApS495

arsenic Trisenox 11/2/2001496

arsenic trioxide Trisenox 10/18/2001

Treatment of the on-off fluctuations associated with late-stage Parkinson's disease.

Pentech Pharmaceuticals, Inc.

For the treatment of patients in a vegetative state or minimally conscious state for up to 12 months following a severe traumatic brain injury (traumatic or spontaneous)

NeuroHealing Pharmaceuticals, Inc.

AQ-13 (4-aminoquinoline analog)

Immtech Pharmaceuticals, Inc.

Treatment of malignant pleural mesothelioma

Treatment of beta-hemoglobinopathies and beta-thalassemia.

Perrine, Susan P., M.D.


Treatment of Neimann-Pick disease, type C

Treatment of acute myelocytic leukemia subtypes M0, M1, M2, M4, M5, M6 and M7

Teva Branded Pharmaceutical Products R&D, Inc.


Teva Branded Pharmaceutical Products R*D, Inc.


of 400



497

arsenic trioxide Trisenox 6/13/2003 Treatment of liver cancer498

Arsenic trioxide Trisenox 3/4/2005 Treatment of malignant glioma499

arsenic trioxide Trisenox 7/17/2000500

Arsenic trioxide Trisenox 4/28/2000 Treatment of multiple myeloma.501

Arsenic trioxide Trisenox 5/13/2003502

arsenic trioxide capsule (oral) n/a 11/2/2015 Orsenix Holdings BV503

Artesunate n/a 7/19/1999 Treatment of malaria.504

Artesunate n/a 3/28/2006 Immediate treatment of malaria505

arylsulfatase A (rhASA) n/a 2/27/2008506

Ascorbic acid Ascor L 500 8/31/2007 Treatment of scurvy



Treatment of myelodysplastic syndrome.


TEVA Branded Pharmaceutical Products R & D, Inc.



Treatment of acute promyelocytic leukemia.

World Health Organization

US Army Medical Materiel Development Activity

Treatment of metachromatic leukodystrophy


McGuff Pharmaceuticals Inc.


of 400



507

astuprotimut-R n/a 5/29/2009508

ataluren n/a 1/10/2005 PTC Therapeutics, Inc.509


ataluren Translarna 12/10/2014 PTC Therapeutics, Inc.511


ataluren n/a 9/1/2015 Treatment of aniridia PTC Therapeutics, Inc.513

Atezolizumab n/a 10/13/2016 Genentech, Inc.514

Atrasentan n/a 9/29/2016 AbbVie Inc.515

n/a 4/27/2007 TVAX Biomedical, LLC

Treatment of MAGE-A3 positive non-small cell lung cancer

GlaxoSmithKline Biologicals, S.A.

Treatment of Muscular Dystrophy resulting from premature stop mutations in the dystrohin gene


Treatment of mucopolysaccharidosis type I

For use in the treatment of cystic fibrosis resulting fron a nonsense (premature stopcodon) mutation in the cystic bibrosis transmembrane conductance regulatory gene

Treatment of small cell lung cancer (SCLC)

Treatment of pediatric nephrotic syndrome

Attenuated autologous cancer cells and granulocyte macrophage colony stimulating factor in combination with activated autologous blood derived T-cells

Treatment of primary central nervous system malignancies


of 400



516

auranofin Ridaura 4/30/2010 Treatment of amebiasis517

n/a 10/22/2014 Mayo Clinic518

n/a 5/4/2016519

n/a 10/21/2014520

n/a 11/13/2014521

n/a 1/15/2015

Ctr for Discovery & Innovation in Parasitic Diseas

autologous adipose derived mesenchymal stromal cells


autologous adipose tissue derived mesenchymal stem cells

Treatment of Buerger's disease (thromboangiitis obliterans).

Biostar Stem Cell Research Institute

autologous bone marrow CD34+ cells transduced ex vivo with a self activating HIV-1 -based lentiviral vector, EFS-ADA

Treatment of adenosine deaminase deficient severe combined immunodeficiency

Donald B. Kohn, MD - Professor, UC-UCLA

Autologous CD3+ T cells transduced with retroviral vector containing a chimeric antigen receptor directed against CD19 (Autologous CD3+ T cells containing CD19 chimeric antigen receptor)

Treatment of acute lymphoblastic leukemia (ALL)

Juno Therapeutics, Inc.

autologous CD34+ bone marrow derived stem cells transduced with a self-inactivating gammaretroviral vector encoding the human IL2RG (yc)

Treatment of severe combined immune deficiency-X1

Boston Children's Hospital


of 400



522

n/a 4/30/2010523

n/a 4/19/2012 bluebird bio, Inc.524

n/a 2/26/2014 bluebird bio Inc.525

n/a 3/18/2013 bluebird bio, Inc.526

n/a 10/4/2016

Autologous CD34+ cells transfected with lentiviral vector containing the human WAS cDNA (Telethon 003)

Treatment of Wiskott Aldrich syndrome

GlaxoSmithKline Intellectual Property Development

autologous CD34+ hematopoietic stem cells tranduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA

Treatment of andrenoleukodystrophy

autologous CD34+ hematopoietic stem cells transduced with LentiGlobin BB305 lentiviral vector encoding the human BA-T87Q-globin gene

For the treatment of Sickle Cell Disease

autologous CD34+ hematopoietic stem cells transduced with LentiGlobin BB305 lentiviral vector encoding the human BA-T87Q-globin gene

Treatment of B-thalassemia major and intermedia

autologous CD4+/CD8+ T cells expressing a CD19 chimeric antigen receptor (CAR) and a truncated epidermal growth factor receptor.




of 400



527

n/a 9/7/2016528

n/a 4/27/2016529

n/a 11/6/2014530

n/a 3/28/2016 Adaptimmune, LLC531

n/a 11/19/2013 iREG Medical AB532

n/a 6/1/2007533

n/a 9/27/2016

autologous CD4+/CD8+ T cells expressing a CD19 chimeric antigen receptor and a truncated epidermal growth factor receptor



autologous CD4+/CD8+ T cells expressing a CD19 chimeric antigen receptor and truncated epidermal growth factor receptor



autologous CD4+/CD8+ T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19

Treatment of acute lymphoblastic leukemia (inclusive of B-cell acute lymphoblastic leukemia)


Autologous CD4+/CD8+ T cells transduced with lentiviral vector directed against the NY-ESO-1 protein


autologous CD4+CD25hiFoxP3+regulatory T cells

Prevention of graft rejection following solid organ transplantation

Autologous cultured endothelial cells on a donor human corneal disk

Treatment of Fuch's dystrophy, pseudophakic bullous keratopathy, and bullous keratopathy

Cellular Bioengineering, Inc.

Autologous dendritic cell/tumor antigens

Treatment of glioblastoma multiforme (GBM)

China Medical University Hospital


of 400



534

n/a 5/6/2014 Amphera BV535

Dcvax-Brain 11/29/2002536

Cvac(Tm) 9/13/2010 Treatment of ovarian cancer. Prima Biomed Ltd.537

M-Vax 2/23/1999538

Permaderm 6/1/2012539

n/a 3/9/2015 Cell Medica, Inc.

autologous dendritic cells pulsed with allogeneic tumor cell lysate

Treatment of malignant mesothelioma

Autologous dendritic cells pulsed with autologous antigens from primay malignant brain tumor cells

Treatment of primary brain malignant cancer

Northwest Biotherapeutics, Inc.

Autologous dendritic cells pulsed with recombinant human fusion protein (mucin1- glutathione S transferase) coupled to oxidized polymannose

Autologous DNP-conjugated tumor vaccine

For adjuvant therapy in melanoma patients with surgically resectable lymph node metastasis (Stage III and limited Stage IV disease).

Avax Technologies, Inc.

Autologous Engineered Skin Substitute

Treatment of hospitalized patients with deep partial and full thickness burns requiring grafting.

Amarantus BioScience Holdings, Inc.

autologous Epstein-Barr virus specific T-cells

Treatment of Epstein-Barr virus positive non-Hodgkin lymphomas.


of 400



540

Alecsat 9/13/2013 CytoVac A/S541

n/a 5/10/2016 Caladrius Biosciences542

n/a 6/10/2014543

n/a 9/3/2004544

4/3/2008545

Biovaxid 10/18/2011546

n/a 6/7/2011 Tengion, Inc.

autologous ex vivo expanded CD4+-enriched leukocytes treated with the de-methylating agent 5-aza-2Ã¢â¿¬â¿¢-deoxycytidine


autologous ex vivo expanded polyclonal CD4+CD25+CD1271o/-FOXP3+ Regulatory T cells

Treatment of type 1 diabetes mellitus with residual beta cell function

autologous genetically modified human dermal fibroblasts

Treatment of dystrophic epidermolysis bullosa.

Fibrocell Technologies, Inc.

Autologous incubated macrophage

Therapy to improve the motor and sensory neurological outcome in acute cases of spinal cord injury

Proneuron Biotechnologies, Inc.

autologous lymphocytes depleted ex vivo of immunoreactive T cells using 4,5


Treatment of chronic graft versus host disease


Autologous lymphoma-derived immunoglobulin idiotype antigen vaccine conjugated to keyhole limpet hemocyanin


Biovest International, Inc.

autologous neo-uninary conduit

Treatment of bladder dysfunction requiring incontinent urinary diversion.


of 400



547

Rhinocytes 2/1/2008 RhinoCyte, Inc.548

Rhinocytes 12/31/2008 RhinoCyte, Inc.549

n/a 7/14/2005 TissueTech, Inc.550

n/a 6/30/2016 Novadip Biosciences551

n/a 3/27/2014 Kite Pharma, Inc.552

Eccs-50 11/9/2016553

n/a 3/14/2014

Autologous olfactory neural progenitors

Treatment of spinal cord injury patients with ASIA Impairment grades A, B, or C

autologous olfactory neural progenitors


Autologous or allogeneic limbal epithelial stem cells expanded ex vivo on human amniotic membrane

Treatment of ocular surface diseases that are characterized by total limbal stem cell deficiency

autologous osteogenic cells cultured from adipose tissue derived stem cells embedded in extracellular matrix with demineralized bone matrix.

Treatment of congenital pseudarthrosis of the tibia

autologous peripheral blood T lymphocytes transduced with retroviral vector containing anti CD19 CD28/CD3 zeta chimeric antigen receptor


Autologous stromal vascular cell fraction from adipose tissue (central facitily processed)

Treatment of impaired hand function due to systemic sclerosis

Cytori Therapuetics, Inc.

autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19




of 400



554

n/a 1/31/2014555





n/a 4/20/2016 Kite Pharma, Inc.

Autologous T Cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19

For the treatment of Acute Lymphoblastic Leukemia


autologous T-cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor

Treatment of primary mediastinal B-cell lymphoma.

Autologous T-cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor

Treatment of acute lymphoblastic leukemia. (ALL).




Treatment of follicular lymphoma.




of 400



560

n/a 5/11/2016 Treatment of multiple myeloma bluebird bio, Inc.561

n/a 5/6/2015 Treatment of glioblastoma562

Oncophage 5/10/2002 Agenus, Inc.563

Oncophage 7/11/2002 Agenus, Inc.564

n/a 7/24/2012 Duke University565

n/a 8/26/2009 Glaxo Group Limited566

Autolymphocyte therapy n/a 7/12/1994 Cytogen Corporation567

avicin d n/a 3/24/2015 Treatment of multiple myeloma

autologous T-lymphocytes transduced with anti-BCMA02 CAR lentiviral vector encoding a chimeric antigen receptor (CAR) specific for the human B cell maturation antigen

autologous tumor cells fused with polyethylene glycol to human allogeneic FO-1, DNA plasmid transfected tumor cell line

Sebastiano Gattoni-Celli, MD

autologous tumor-derived gp96 heat shock protein-peptide complex


autologous tumor-derived gp96 heat shock protein-peptide complex

Treatment of metastatic melanoma

autologous umbilical cord blood

Treatment of pediatric (0-16 yrs old inclusive) cerebral palsy due to acquired brain injury

autologus CD34+ cells transfected with retroviral vector containing adenosine deaminase gene

Treatment of severe combined immunodeficiency due to adenosine deaminase deficiency.

Treatment of renal cell carcinoma.

Avicin Therapeutics Ltd.


of 400



568aviptadil n/a 2/22/2005

569Azacitidine Vidaza 6/18/2008 Celgene Corporation

570

Azathioprine Imuran 9/14/1999 Oral Solutions, Inc.571

Azurin-p28 n/a 12/2/2015 Treatment of glioma572

n/a 8/9/2006 OncoVac Corporation573

n/a 2/29/2016574

Bacitracin Altracin 3/13/1984 A. L. Laboratories, Inc.575

Baclofen Lioresal Intrathecal 9/26/1994 Medtronic, Inc.576

baclofen n/a 12/2/2003 Treatment of dystonia577

baclofen n/a 12/16/1991578

baclofen Gablofen 10/28/2015 Mallinckrodt, Inc.


Mondobiotech Laboratories AG


Treatment of oral manifestations of graft-versus-host disease.

CDG Therapeutics, Inc.

Bacillus Calmette-Guerin vaccine

Treatment of stage IIb through IV metastatic melanoma

Bacillus subtilis oxalate decarboxylase

Treatment of pediatric hyperoxaluria

Allena Pharmaceuticals

Treatment of antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile.

Treatment of spasticity associated with cerebral palsy.

Medtronic Neurological

Treatment of intractable spasticity due to multiple sclerosis or spinal cord injury.

Metacel Pharmaceuticals, LLC

Treatment of complex regional pain syndrome.


of 400



579

n/a 9/26/2013580

bardoxolone n/a 3/30/2015581

Bardoxolone n/a 8/6/2008 Treatment of pancreatic cancer582

basimglurant n/a 3/9/2012 Treatment of Fragile X Syndrome583

beclomethasone n/a 3/4/2009584

n/a 11/19/2012 Soligenix, Inc585

Bec 8/28/2001 Soligenix, Inc.586

Orbec(R) 7/24/2009 Soligenix, Inc.587

n/a 12/18/2007 Soligenix, Inc.

bacterium Bacteroides thetaiotaomicron

Treatment of active Crohn's disease in the pediatric population

4D Pharma Research Ltd


Reata Pharmaceuticals, Inc.

Reata Pharmaceuticals, Inc.

Hoffmann-La Roche, Inc.

Treatment of pediatriac patients with ulcerative colitis

Aptalis Pharma US, Inc.

beclomethasone 17,21-dipropionate

Prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster


Prevention of gastrointestinal graft-versus-host disease


Treatment of gastrointestinal symptoms with chronic graft versed host disease in patients undergoing allogenic hematopoietic cell transplantation

beclomethasone 17,21-diproprionate

Treatment of pediatric patients with Crohn disease.


of 400



588

Beclomethasone dipropionate n/a 3/27/1998 Soligenix, Inc.589

beloranib n/a 1/15/2013 Zafgen, Inc.590

n/a 9/10/2013 Supratek Pharma, Inc.591

n/a 11/5/2015592

benznidazole n/a 4/14/2014 Treatment of Chagas disease Chemo Research, S.L.593

benzoate Naben 7/6/2012594

Total Block Vl Spf 75 8/13/2001595

Benzydamine hydrochloride Tantum 5/18/1998

For oral administration in the treatment of intestinal graft-versus-host disease.

Treatment of Prader-Willi syndrome

bendamustine hydrochloride with betadex sulfobutyl ether sodium


Bendamustine oral doseage formulation


Exinda Theapeutics LLC

Treatment of pediatric schizophrenia

SyneuRx International (Taiwan) Corp.

Benzophenone-3, octylmethoxycinnamate, avobenzone, titanium dioxide, zinc oxide

For the prevention of visible light induced skin photosensitivity as a result of porfimer sodium photodynamic therapy

Fallien Cosmeceuticals Ltd.

Prophylactic treatment of oral mucositis resulting from radiation therapy for head and neck cancer.

Angelini Pharmaceuticals, Inc.


of 400



596

Pre-Pen/Mdm 9/28/1987 AllerQuest LLC597

Beractant 12/20/1993 Ross Laboratories598

Beraprost n/a 4/29/1999 LungRx, Inc.599

beraprost sodium 314d n/a 12/22/2011 Lung Rx, Inc.600

Beta alethine Betathine 3/24/1997 Treatment of multiple myeloma.601

Beta alethine Betathine 3/24/1997602

Betahistine dihydrochloride n/a 11/8/2007

Benzylpenicillin, benzylpenicilloic, benzylpenilloic acid

Assessing the risk of administrating penicillin when it is the preferred drug of choice in adult patients who have previously received penicillin and have a history of clinical sensitivity.

Survanta Intratracheal Suspension

Treatment of full-term newborn infants with respiratory failure caused by meconium aspiration syndrome, persistent pulmonary hypertension of the newborn, or pneumonia and sepsis.

Treatment of pulmonary arterial hypertension associated with any New York Heart Association classification (Class I, II, III, or IV).


Dovetail Technologies, Inc.

Treatment of metastatic melanoma.

Dovetail Technologies, Inc.

Treatment of obesity associated with Prader Willi syndrome

Floyd R. Sallee, M.D., Ph.D.


of 400



603betamethasone n/a 10/7/2015

604Betulinic acid n/a 8/9/2007

605bevacizumab n/a 10/21/2010

606bevacizumab Avastin 10/20/2004 Treatment of pancreatic cancer Genentech, Inc.

607

bevacizumab Avastin 11/20/2009 Genentech, Inc.608

bevacizumab Avastin 10/13/2009 Genentech, Inc.609 bevacizumab n/a 3/10/2016 Treatment of Coat's disease MicroSert, Ltd.610 bevacizumab Avastin 1/27/2016 Treatment of mesothelioma Genentech, Inc.611

bezafibrate Bezalip 7/24/2013612 BF2.649 (Pitolisant) n/a 5/17/2010 Treatment of narcolepsy Bioprojet Pharma613

Fang 10/22/2014 Treatment of Ewing's sarcoma Gradalis, Inc.614

Fang 2/17/2012 Gradalis, Inc.

Treatment of Ataxia Telangiectasia.

Grace Therapeutics, LLC

Topical treatment of metastatic melanoma

Advanced Life Sciences, Inc. (ALS)

Treatment of hereditary hemorrhagic telangiectasia

Terence M. Davidson, MD

In combination with a platinum and 5-FU or capecitabine for the treatment of stomach cancer.

Treatment of melanoma stages IIb through IV as part of a combination chemotherapy regimen

For therapeutic treatment of Barth syndrome

Barth Sydrome Foundation, Inc.

bi-shRNA furin and GMCSF Autologous Tumor Cell Vaccine

bi-shRNAfurin and granulocyte macrophage colony stimulating factor augmented autologus tumor cell vaccine

Treatment of stage IIB to IV melanoma


of 400



615

Fang 4/18/2011 Treatment of ovarian cancer Gradalis, Inc.616

bifidobacterium infantis 35624 n/a 3/24/2008617

n/a 1/16/2003618

Primeskin 9/6/2016619

Bindarit n/a 2/3/1998 Treatment of lupus nephritis.620

binimetinib n/a 11/19/2013 Array BioPharma, Inc.621

binimetinib n/a 7/31/2014 Treatment of ovarian cancer Array Biopharma, Inc.622

n/a 4/27/2006 TissueTech, Inc.

bi-shRNAfurin and granulocyte macrophage colony stimulating factor augmented autologus tumor cell vaccine

Treatment of pediatric ulcerative colitis

Alimentary Health Limited

bifidobacterium longum infantis 35624

Treatment of pediatric Crohn's disease

Alimentary Health Limited

bilayer, engineered collagen hydrogel-based skin graft composed of autologous keratinocytes and fibroblasts

Treatment of partial deep dermal and full thickness burn wounds

University Children's Hospital Zurich

Angelini Pharmaceuticals, Inc.

Treatment Stage IIB-IV melanoma.

Bio-engineered oral mucosal tissue

For use as a graft for restoring a cornea-like epithelial phenotype to substitute for the normal corneal epithelium that is lost in patients due to total limbal stem cell deficiency


of 400



623

n/a 2/11/2002 Excorp Medical, Inc.624

n/a 3/2/2000 Treatment of sickle cell disease. ICAgen Inc.625

bisantrene HCl n/a 2/14/2014 Update Pharma, Inc.626

n/a 8/8/2013627

n/a 8/8/2013628

n/a 9/14/2011629

n/a 2/10/2015630

bivalirudin Angiomax 11/2/2005

Bioartificial liver system utilizing xenogenic hepatocytes in a hollow fiber bioreactor cartridge (BAL)

Treatment of patients with acute liver failure presenting with encephalopathy deteriorating beyond Parson's grade 2

Bis(4-fluorophenyl)phenylacetamide


bispecific antibody (monoclonal antibody)

Treatment of HER2-expressing advanced adenocarcinoma of the stomach and gastroesophageal junction

Merrimack Pharmaceuticals, inc.

bispecific antibody (monoclonmal antibody)

Treatment of HER2-expressing adenocarcinoma of the esophagus

Merrimack Pharmaceuticals, Inc.

bispecific antibody targeting interleukin 4 (IL-4) and interleukin 13 (IL-13)


Sanofi-Aventis US, Inc.

bivalent anti-human myostatin adnectin-IgG1

Treatment of duchenne muscular dystrophy

Bristol-Myers Squibb Co.

For use as an anticoagulant in patients with or at risk of heparin-induced thrombocytopenia/heparin-induced thrombocytopenia thrombosis syndrome

The Medicines Company


of 400



631Bleomycin n/a 12/20/2010 Treatment of pancreatic cancer. CIRJ Company Ltd.

632Bleomycin Blenoxane 2/9/1999 Treatment of pancreatic cancer. Genetronics, Inc.

633blinatumomab n/a 5/16/2008 Amgen, Inc.

634blinatumomab n/a 5/16/2008 Amgen, Inc.

635

blinatumomab n/a 2/6/2006 Amgen, Inc.636

Blinatumomab n/a 5/16/2008 Amgen, Inc.637

n/a 5/17/2010 t2cure GmbH638

bortezomib n/a 7/5/2016 BioXcel Corporation639

bortezomib Velcade 2/3/2015640


Botulinum toxin type A Botox 12/6/1991 Allergan, Inc.

Treatment for hairy cell leukemia.

Treatment of prolymphocytic leukemia

Treatment of indolent B-cell lymphoma, excluding CLL and NHL with CNS involvement


Bone marrow-derived mononuclear cells

Treatment of thromboangiitis obliterans (Buerger's disease)

Treatment of neurofibromatosis type 2 (NF2)



Treatment of follicular non-Hodgkin lymphoma


Treatment of dynamic muscle contracture in pediatric cerebral palsy patients.


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642Botulinum toxin type A Dysport 3/23/1989

643Botulinum toxin type A Dysport 8/12/1998

644

Botulinum toxin type A n/a 9/15/1992645

Botulinum toxin type F n/a 10/24/1991 Ipsen Limited646

Bovine colostrum n/a 11/19/1990647

Sporidin-G 3/1/1994 GalaGen, Inc.648

bovine lactoferrin n/a 2/23/2015649

bovine lactoferrin n/a 2/19/2015

Treatment of essential blepharospasm.

Porton International, Inc.

Treatment of spasmodic torticollis (cervical dystonia).

Ipsen Biopharm Limited

Treatment of synkinetic closure of the eyelid associated with VII cranial nerve aberrant regeneration.

Botulinum Toxin Research Associates, Inc.

Treatment of spasmodic torticollis (cervical dystonia).

Treatment of AIDS-related diarrhea.

Hastings, Donald DVM

Bovine immunoglobulin concentrate, Cryptosporidium parvum

Treatment and symptomatic relief of Cryptosporidium parvum infection of the gastrointestinal tract in immunocompromised patients.

Prevention of necrotizing enterocolitis in very low birth weight infants (birth weight less than or equal to 1500 grams)

Metrodora Therapeutics, LLC

Prevention of late-onset sepsis in very low birth weight infants

Metrodora Therapeutics, LLC


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650

Immuno-C 9/30/1993651

Branched chain amino acids n/a 12/23/1988652

Brentuximab vedotin Adcetris 9/7/2016 Seattle Genetics, Inc.653

brentuximab vedotin Adcetris 9/13/2013 Seattle Genetics, Inc.654

brentuximab vedotin Adcetris(R) 1/31/2014 Seattle Genetics, Inc.655



brentuximab vedotin Adcetris 11/19/2012 Treatment of mycosis fungoides Seattle Genetics, Inc.658

brentuximab vedotin n/a 5/23/2016 Seattle Genetics, Inc.

Bovine whey protein concentrate

Treatment of cryptosporidiosis caused by the presence of Cryptosporidium parvum in the gastrointestinal tract of patients who are immunodeficient/immunocompromised or immunocompetent.

Biomune Systems, Inc.

Treatment of amyotrophic lateral sclerosis.

Mount Sinai Medical Center

Treatment of primary cutaneous CD30-positive T-cell lymphoproliferative disorders

Treatment of patients with angioimmunoblastic T-cell lymphoma

Treatment of patients with diffuse large B-cell lymphoma.

Treatment of patients with peripheral T-cell lymphoma, not otherwise specified

Treatment of enteropathy-associated T-cell lymphoma.

Treatment of adult T-cell leukemia/lymphoma


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659

brigatinib n/a 4/28/2016660

brilliant blue G Brilliant Peel 12/16/2009661

Brilliant Blue G Dorc Ilm-Blue 7/31/2012662

Brimonidine Alphagan 2/7/2000 Allergan, Inc.663

Brivaracetam n/a 10/5/2005 UCB Pharma, Inc.664

Broxuridine Broxine/Neomark 9/18/1995 NeoPharm, Inc.665


bryostatin 1 n/a 3/31/2015

Treatment of anaplastic lymphoma kinase-positive (ALK+), c-ros 1 oncogene positive (ROS1+), or epidermal growth factor receptor positive (EGFR+) non-small cell lung cancer (NSCLC).

ARIAD Pharmaceuticals, Inc.

For use in ophthalmic surgery to aid in the removal of the inner limiting membrane of the eye.

Fluron GmbH - Subsidiary of Geuder AG

To selectively stain the thickened internal limiting membrane, which has formed onto the inner side of the retina in vitreo-retinal disorders

Dutch Opthalmic Research Center

Treatment of anterior ischemic optic neuropathy.

Treatment of symtomatic myoclonus

Radiation sensitizer in the treatment of primary brain tumors.

Bruton's Tyrosine Kinase (Btk) Inhibitor

Treatment of chronic lymphocytic leukemia (CLL).

Treatment of Fragile X Syndrome.

Neurotrope BioScience, Inc.


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667

bryostatin-1 n/a 12/3/2001 GPC Biotech, Inc.668

Bucillamine n/a 10/22/2015 Treatment of cystinuria669

budesonide Nefecon 5/17/2010 Pharmalink AB670

budesonide Uceris 5/6/2013 Santarus, Inc.671

Buffered Ursodeoxycholic Acid Ursocarb 9/3/2004 Digestive Care, Inc.672

bupivacaine Transdur 6/18/2008673

bupivacaine hydrochloride n/a 5/31/2016674

Busulfan Spartaject 4/21/1994675

Busulfan Spartaject 7/7/1997 SuperGen, Inc.676

busulfan Partaject 11/25/2002 SuperGen, Inc.

For use in combination with paclitaxel in the treatment of esophageal cancer

Revive Therapeutics, Ltd.

To slow the progression of immunoglobulin A nephropathy & delay kidney failure in patients affected by the disease.

Treat of ulcerative colitis in pediatric patients aged 0 through 16 years.

Treatment of pruritus in patients with Alagille Syndrome

Relief of persistent pain associated with postherpetic neuralgia

Impax Laboratories, Inc.

treatment of pain associated with postherpetic neuralgia.

Grace Therapeutics, LLC

For use as preparative therapy for malignancies treated with bone marrow transplantation.

Sparta Pharmaceuticals, Inc.

Treatment of primary brain malignancies.

Preparative therapy for pediatric patients undergoing bone marrow transplantation


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677

Buthionine sulfoxamine n/a 10/5/2005678

Buthionine sulfoxamine n/a 10/5/2005679

butylidenephthalide n/a 8/5/2015 Treatment of Malignant Glioma680

Butyrylcholinesterase n/a 9/30/1992681

Butyrylcholinesterase n/a 3/25/1992682

C1 esterase inhibitor (human) n/a 8/21/1996683

C1 esterase inhibitor (Human) Cinryze 11/30/2016684

C20-D3-retinyl acetate n/a 9/16/2010 Treatment of Stargardt's disease685

C21H27O10P Minnelide 3/30/2015 Treatment of gastric cancer.

Use as a modulator of chemotherapy for the treatment of pediatric patients with primary malignant brain tumors

USC-CHLA Institute for Pediatric Clinical Research

For use in children as a modulator of chemotherapy for the treatment of pediatric patients with neuroblastoma


Everfront Biotech, Inc.

Treatment of post-surgical apnea.

Shire Laboratories Inc.

For the reduction and clearance of toxic blood levels of cocaine encountered during a drug overdose.

Shire Laboratories Inc.

Treatment and prevention of angioedema caused by C1-esterase inhibitor deficiency.

Alpha Therapeutic Corporation

Treatment of acute antibody mediated rejection following kidney transplantation

Shire ViroPharma, Inc.

Alkeus pharmaceuticals, Inc.

Minneamrita Therapeutics, LLC


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686C24H28N8O7S2 n/a 4/2/2015 Curis, Inc.

687C66H100N6O27 n/a 3/11/2013 GenSpera, Inc.

688

caffeine and sodium benzoate n/a 8/22/2012689

Calcium acetate n/a 6/27/1989 Pharmedic Company690

n/a 12/20/2010691

Calcium carbonate 6/6/1990692

Calcium gluconate Calgonate 11/20/1997 Calgonate Corp.693

Calcium gluconate gel H-F Gel 5/21/1991694

Calcium gluconate gel 2.5% n/a 9/10/1990695

calfactant Infasurf 9/5/2000 ONY, Inc.

Treatment of diffuse large B-cell lymphoma (DLBCL).

Treatment of of hepatocellular carcinoma

Treatment of seizure prolongation in patients undergoing electroconvulsive therapy

Luitpold Pharmaceuticals, Inc.

Treatment of hyperphosphatemia in end stage renal disease.

calcium benzoate and risperidone

Treatment of pediatric patients with schizophrenia

University of California, Los Angeles

R & D Calcium Carbonate/600

Treatment of hyperphosphatemia in patients with end stage renal disease.

R & D Laboratories, Inc.

For use as a wash for hydrofluoric acid spills on human skin.

For use in the emergency topical treatment of hydrogen fluoride (hydrofluoric acid) burns.

Calgonate Corporation

Emergency topical treatment of hydrogen fluoride (hydrofluoric acid) burns.

Paddock Laboratories, Inc.

Treatment of acute respiratory distress syndrome (ARDS)


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696camostat n/a 5/18/2011 Treatment of chronic pancreatitis NIXS Corporation

697cannabidiol n/a 11/14/2013 Treatment of Dravet syndrome. GW Pharma Ltd.

698cannabidiol n/a 11/29/2016 Talent biotechs Ltd.

699

cannabidiol n/a 4/22/2015 GW Pharma Ltd.700

cannabidiol n/a 4/19/2016 GW Pharma Ltd.701

cannabidiol n/a 7/1/2014 Treatment of Dravet syndrome702

cannabidiol n/a 8/20/2014703

cannabidiol n/a 6/13/2016 Treatment of infantile spasms GW Research Ltd.704

cannabidiol n/a 7/23/2015 Treatment of infantile spasms705

cannabidiol n/a 11/17/2014706

cannabidiol n/a 2/23/2016 Treatment of Fragile X syndrome707

cannabidiol n/a 9/24/2014 Treatment of glioma708

cannabidiol n/a 7/14/2015 Talent biotechs Ltd.

Treatment of Graft versus Host Disease

Treatment of neonatal hypoxic ischemic encephalopathy

Treatment of tuberous sclerosis complex.

Insys Development Company, Inc.




Treatment of pediatric schizophrenia (pediatrics is defined as 0 through 16 years of age)


Zynerba Pharmaceuticals, Inc.


Prevention of Graft versus Host Disease (GVHD).


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709cannabidiol n/a 6/23/2014

710cannabidiol; n/a 2/27/2014 GW Pharma Ltd.

711 cannabidivarin n/a 11/30/2016 Treatment of Rett syndrome GW Research Ltd.712

cantharidin n/a 7/24/2012 Orenova Group, LLC713 cantrixil n/a 4/20/2015 Treatment of ovarian cancer CanTx, Inc.714

Caplacizumab n/a 4/14/2009 Ablynx NV715

n/a 10/28/2009716

n/a 2/14/2014 Treatment of systemic sclerosis717

capsaicin n/a 10/23/2002 Treatment of erythromelalgia718

Capsaicin n/a 9/29/2006719

Capsaicin n/a 8/3/2005720

capsaicin Qutenza 5/2/2003

Treatment of Lennox-Gastaut syndrome


Treatment of Lennox-Gastaut syndrome

Treatment of perforating diseases, including Kyrle's disease, reactive perforating collangenosis, perforating folliculitis and elastosis perforans serpiginosa

Treatment of thrombotic thrombocytopenic purpura

caprine hyperimmune serum against HIV lysate


Daval International Limited

caprine hyperimmune serum against HIV lysate

Daval International Limited


Treatment of intermetatarsal neuroma (Morton's Neuroma) that does not respond to conservative treatment and requires either neurectomy or neurolysis

Centrexion Corporation

Treatment of postherpetic neuralgia.

TheraQuest Biosciences, LLC




of 400



721

carbenoxolone n/a 7/2/2014722

carbetocin (nasal spray) n/a 4/11/2014723

carbon dioxide n/a 12/17/2015 Capnia, Inc.724

carbon monoxide n/a 8/16/2016 Proterris, Inc.725

carbon monoxide n/a 9/28/2012 Treatment of sickle cell disease726

n/a 2/10/2015 Treatment of AL amyloidosis727

cardiotrophin-1 n/a 6/24/2008 Digna Biotech, S.L.728

cardiotrophin-1 n/a 10/16/2014 Digna Biotech, S.L.729

cardiotrophin-1 n/a 9/13/2011 Treatment of acute liver failure Digna Biotech S.L.730

carglumic acid Carbaglu 6/17/2014 Treatment of organic acidemias Orphan Europe SARL731

carisbamate n/a 3/16/2012 SK Life Science, Inc.

Treatment of Huntington's Disease

Oxalys Pharmaceuticals, Inc.

Treatment of Prader Willi syndrome

Ferring Pharmaceuticals, Inc.


Treatment of idiopathic pulmonary fibrosis (IPF).

Hillhurst Biopharmaceuticals, Inc.

carboxy pyrrolidine hexanoyl pyrrolidine carboxylate

Glaxo Group Limited, England d/b/a GlaxoSmithKline

To protect the liver from ischemia-reperfusion injury inherent to the procedure of transplantation.

Prevention of ischemia-reperfusion injury in kidney transplant recipients

Management of patients with infantile spasms


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732carlumab n/a 10/24/2006 Treatment of pancreatic cancer Centocor, Inc.

733Carmustine n/a 7/3/2000

734

Cascara sagrada fluid extract n/a 3/21/1989 Intramed Corporation735

n/a 2/18/2016736

catumaxomab n/a 7/1/2009 Treatment of gastric cancer737

Catumaxomab Removab 6/9/2006 Treatment of ovarian cancer738

n/a 12/20/2013 DiaVacs, Inc.739

cediranib n/a 12/13/2010 Treatment of glioblastoma740

Ceftriaxone sodium Rocephin 3/28/2006741

celiprolol n/a 1/5/2015742

Apocell 3/18/2013

Treatment of intracranial malignancies.

Direct Therapeutics, Inc.

Treatment of oral drug overdosage to speed lower bowel evacuation.

CaspaCIDe System (combination product) consisting of allogeneic T Cell genetically modified to contain an inducible caspase 9 gene and Rimiducid

Replacement T-cell therapy for the treatment of immunodeficiency and graft versus host disease after allogeneic hematopoietic stem cell transplant

Bellicum Pharmaceuticals, Inc.

Neoviibiotech North America, Inc.

Neoviibiotech North America, Inc.

CD40/CD80/CD86 modified autologous dendritic cell therapy

Treatment Type 1 diabetes mellitus patients with residual beta cell function

National Institutes of Health


Mass General Hospital

Treatment of Ehlers-Danlos syndrome

Acer Therapeutics, Inc.

cell based therapeutic composed of allogeneic donor apoptotic cells

Prevention of graft versus host disease

Enlivex Therapeutics Ltd.


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n/a 7/10/2002744

cellspan esophageal implant n/a 11/29/2016 Biostage, Inc.745

cenersen Aezea 6/18/2008 Eleos, Inc.746

cenersen Aezea 2/27/2008 Eleos, Inc.747

cenersen n/a 5/8/2006 Eleos, Inc.748

ceramide n/a 8/8/2016 Treatment of liver cancer Keystone Nano, Inc.749

cerebrolysin n/a 4/5/2016750

cerliponase alfa n/a 4/1/2013

Cells produced using the AastromReplicelle System and SC-I Therapy Kit

For use in patients receiving high dose chemotherapy who are unable to generate an acceptable dose of peripheral blood stem cells and who have a sufficient bone marrow aspirate without morphological evidence of tumor

Aastrom Biosciences Incorporated

Restore the structure and function of the esophagus subsequent to esophageal damage due to cancer, injury, or congenital abnormality

Treatment of stage IIB through IV melanoma



Treatment of frontotemporal dementia, including all subvariants

EVER Neuro Pharma GmbH

Treatment of neuronal ceroid lipofuscinosis type 2



of 400



751

cethromycin Restanza(Tm) 9/9/2009752

cethromycin n/a 2/28/2007753

cethromycin Restanza(Tm) 9/9/2009754

n/a 2/10/1999 Treatment of multiple myeloma. NeoRx Corporation755

chelmab-y or chelamusab-Y Oncorad Ov103 4/24/1990 Treatment of ovarian cancer. Cytogen Corporation756

chenodeoxycholic acid n/a 2/12/2007 Baxalta US, Inc.757

Chenodeoxycholic acid Chenofalk 1/29/2004758

chenodiol Chenadal 3/22/2010 Retrophin, Inc.759

n/a 7/28/2016760

n/a 11/25/2014

Prophylactic treatment of tularemia due to Francisella tularensis.

Advanced Life Sciences, Inc.

Prophylactic treatment of patients exposed to inhalation anthrax.

Advanced LIfe Sciences, Inc.

Prophylactic treatment of plague due to Yersinia pestis

Advanced Life Sciences, Inc.

Chelating agent delivering Holmium-166

Treatment of cerebrotendinous xanthomatosis


Dr. Falk Pharma GmbH


chimeric antigen receptor directed against the target protein CD4 lentivirally transfected T cells

Treatment of peripheral T-cell lymphoma

iCell Gene Therapeutics

chimeric fusion protein of recombinant human alpha-N-acetylglucosaminidase and human insulin-like growth factor 2

Treatment of mucopolysaccharidosis III Type B (MPS IIIB, Sanfilippo Syndrome Type B)



of 400



761

n/a 10/4/2005762



n/a 11/20/2012 Treatment of gastric cancer765

n/a 10/31/2006 Treatment of pancreatic cancer Morphotek, Inc.766

n/a 8/3/2000 Biosynexus, Inc.767

Peridex 8/18/1986768

Patul-End 2/18/1997 Ear Foundation769

chloropyramine n/a 10/22/2010 Treatment of pancreatic cancer770

chloroquine n/a 5/20/2015 DualTpharma B.,V.

Chimeric monoclonal antibodies, c-alphaStx2

For treatment of shiga-toxin producing bacterial infection

Thallion Pharmaceuticals, Inc.

chimeric monoclonal antibody against Claudin 6

Ganymed Pharmaceuticals AG

chimeric monoclonal antibody against claudin-18 splice variant 2

Ganymed Pharmaceuticals AG

chimeric monoclonal antibody to claudin 18 splice variant 2

GANYMED Pharmaceuticals AG

Chimeric monoclonal antibody to mesothelin

Chimeric, humanized monoclonal antibody to staphylococcus

Prophylaxis of Staphylococcus epidermidis sepsis in low birth weight (1500 grams or less) infants.

Chlorhexidine gluconate mouthrinse

For use in the amelioration of oral mucositis associated with cytoreductive therapy used in conditioning patients for bone marrow transplantation therapy.

Procter & Gamble Company

chlorobutanol/propylene glycol/hydrochloric acid

Treatment of patulous eustachian tube

CurFAKtor Pharmaceuticals, LLC



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771Chlorotoxin n/a 12/18/2007 Treatment of malignant glioma Morphotek, Inc.

772chlorotoxin n/a 12/2/2008 Morphotek, Inc.

773

n/a 6/23/2015 Blaze Bioscience, Inc.774

cholest-4-en-3-one, oxime n/a 2/17/2009 Genentech, Inc.775

Choline chloride Intrachol 7/20/2006776

Choline chloride Intrachol 2/10/1994777

choline tetrathiomolybdate n/a 8/25/2011 Treatment of Wilson's disease.778

n/a 12/1/1997 Curis, Inc.779

n/a 12/22/2014 JDS Therapeutics, LLC780

Ciliary neurotrophic factor n/a 1/30/1992

Treatment of stage IIb, IIc, III & IV melanoma

chlorotoxin conjugated to indocyanine green dye

Diagnostic for the management of malignant brain tumors

Treatment of spinal muscular atrophy.

Prevention and/or treatment of choline deficiency in patients on long-term parenteral nutrition

Alan L. Buchman, MD, MSPH

Treatment of choline deficiency, specifically the choline deficiency, hepatic steatosis, and cholestasis, associated with long-term parenteral nutrition.

Alan L. Buchman, MD, MSPH

Wilson Therapeutics AB

Chondrocyte-alginate gel suspension

For use in correcting vesicoureteral reflux in the pediatric population.

chromium picolinate and chromium histidinate

Treatment of pediatic polycystic ovary syndrome (0 through 16 years of age)


Regeneron Pharmaceuticals Inc


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781

cinacalcet Sensipar 9/7/2016 Amgen, Inc.782

Cintredekin Besudotox n/a 4/30/2010783

ciprofloxacin n/a 6/1/2011 Aradigm Corporation784

ciprofloxacin DPI 2/2/2010785

n/a 4/17/2014786

n/a 1/19/2010787 Cisplatin n/a 9/6/2016 Treatment of anal cancer Privo Technologies788

Cisplatin ChemoThin Wafer n/a 11/3/2015 Privo Technologies789

Slit Cisplatin For Inhalation 3/20/2007 Treatment of osteosarcoma

Treatment of secondary hyperparathyroidism (HPT) in pediatric patients with chronic kidney disease receiving dialysis



The management of bronchiectasis

Ciprofloxacin Pulmosphere(R)

Management of pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis patients


ciprofloxacin dry powder inhaler

Treatment of non-cystic fibrosis bronchiectasis


cis-adamantane-2-spiro-3'-8'-[4'-[2'-(4'-morpholinyl)ethoxy]phenyl]-1',2,'4'-trioxaspiro[4.5] decane mesylate

Treatment of malaria caused by Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, or Plasmodium malariae

Medicines for Malaria Venture (MMV)

Treatment of anatomically accessible oral cancers (lip, tongue, gum, floor of mouth, salivary gland, and other oral cavity)

Cisplatin in liposomal formulation

Eleison Pharmaceuticals LLC


of 400



790

Cisplatin/epinephrine Intradose 4/3/2000791

Cisplatin/epinephrine Intradose 9/7/2000792

civamide Zucapsaicin 12/9/2002793

civamide n/a 2/17/2009794

cladribine n/a 3/19/2015795

Cladribine Mylinax 4/19/1994796

n/a 4/26/2011797

Clazosentan Erajet 2/16/2006798

clenbuterol Spiropent, Ventipulmin 10/27/2014799

Clindamycin Cleocin 10/28/1988 Pfizer Inc.

Treatment of squamous cell carcinoma of the head and neck.

Matrix Pharmaceutical, Inc.

Treatment of metastatic malignant melanoma.

Matrix Pharmaceutical, Inc.

Treatment of postherpetic neuralgia of the trigeminal nerve

Winston Laboratories, Inc.

Treatment of postherpetic neuralgia.

Winston Laboratories, Inc.

Treatment of neuromyelitis optica and neuromyelitis optica spectrum disorder

Chord Therapeutics S.a.r.l.

Treatment of the chronic progressive form of multiple sclerosis.

Johnson & Johnson Pharmaceutical R & D, LLC

clarithromycin, rifabutin, clofazimine

Treatment of pediatric Crohn's disease.

RedHill Biopharma Ltd.

Treatment of cerebral vasospasm following subarachnoid hemorrhage

Actelion Pharmaceuticals Ltd.

Adjunctive therapy with enzyme replacement therapy in the treatment of Pompe disease

Duke University Medical Center

Prevention of Pneumocystis carinii pneumonia in AIDS patients.


of 400



800

Clindamycin Cleocin 10/28/1988 Pharmacia & Upjohn801

Clindamycin hydrochloride n/a 8/9/2006 Treatment of sarcoidosis802

clofarabine Clofarex 3/14/2002803

clofazimine Lamprene 6/25/2014 Treatment of active tuberculosis804

Clonazepam Klonopin 8/4/1994805

Clonazepam Intranasal Spray n/a 12/19/2007806

Clotrimazole n/a 4/24/1995 Treatment of sickle cell disease. Brugnara, Carlo M.D.807

Clotrimazole n/a 6/14/2005 AesRx, LLC808

Clotrimazole n/a 3/13/2006809

clotrimazole otic solution n/a 5/10/2016810

n/a 6/18/2012811

Novoseven 6/18/2004 Novo Nordisk, Inc.

Treatment of Pneumocystis carinii pneumonia associated with AIDS patients.

Autoimmunity Research Foundation


Genzyme Corp (Ilex Products, Inc.)


Treatment of hyperekplexia (startle disease).


Treatment of recurrent acute repetitive seizures

Jazz Pharmaceuticals, Inc.

Topical treatment of children and adults with pouchitis


EnVivo Pharmaceuticals, Inc.

Treatment of fungal otitis externa (otomycosis).

Laboratorios SALVAT S.A.

CNDO-109-activated allogeneic natural killer cells


Coronado Biosciences, Inc.

Coagulation factor VIIa (recombinant)

Prevention of bleeding episodes in Glanzmann's thrombasthenia


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812Coenzyme Q10 n/a 3/5/2001

813

n/a 3/14/2011 Treatment of Friedreich's Ataxia.814

Colchicine n/a 9/25/2007 Treatment of Behcet's Syndrome AR Scientific, Inc.815

n/a 10/13/2016816

n/a 5/18/2016817

n/a 5/2/2016 Treatment of soft tissue sarcoma Immune Design Corp.818

n/a 11/19/2012819

Combretastatin A4 phosphate n/a 5/8/2006 Treatment of ovarian cancer820

Combretastatin A4 Phosphate n/a 7/23/2003


Integrative Therapeutics, Inc.

coenzyme Q10 and d-alpha-tocopherol

NBI Pharmaceuticals, Inc.

Combination of an inactivated purified rabies virus (IPRV) and the PIKA adjuvant (Poly I:C, kanamycin and calcium)


Yisheng US Biopharma, Inc.

combination of disulfiram and copper gluconate


Cantex Pharmaceuticals, Inc.

combinatorial regimen of LV305 (lentiviral vector encoding NY-ESO-1 gene) and G305 (NY-ESO-1 recombinant protein plus GLA-SE)

combretastatin A 1 diphosphate


Mateon Therapeutics, Inc.


Treatment of anaplastic thyroid cancer, medullary thyroid cancer, and stage IV papillary or follicular thyroid cancer



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821

n/a 3/10/2016822

n/a 8/6/2013823

Transmid 12/3/2001824

conjugated bile acids Cobartin 7/18/2003 Jarrow Formulas, Inc.825

Contulakin-G n/a 7/7/2005 Cognetix, Inc.826

copanlisib n/a 2/5/2015827

Copper 64-DOTA-TATE Netmedix (Tm) 5/18/2016 RadioMedix, Inc.828

copper histidine n/a 5/14/2012 Treatment of Menkes disease829

Cordycepin n/a 7/5/2007 OncoVista, Inc.830

corifungin n/a 8/22/2011

competetive small molecule inhibitor of the enzyme O-GlcNAcase


Merck & Company, Inc.

Conjugate of a dengue virus specific small chemical ligand and an amphiphilic PEG based polymer

Treatment of dengue fever (includes dengue hemorrhagic fever and dengue shock syndrome)

NanoViricides Incorporated

conjugate of human transferrin and a mutant diphtheria toxin (CRM 107)

Treatment of malignant tumors of the central nervous system

Xenova Biomedix Limited

Treatment of steatorrhea in patients with short bowel syndrome

Intrathecal treatment of neuropathic pain associated with spinal cord injury



Diagnostic for the management of neuroendocrine tumors.

Stephen G. Kaler, M.D.

Treatment of TdT-positive acute lymphocytic leukemia

Treatment of amebic meningoencephalitis.

Ctr for Discovery & Innovation in Parasitic Diseas


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831corifungin n/a 7/6/2011

832Xerecept 4/6/1998

833Coumarin Onkolox 12/22/1994 Drossapharm LTD

834coversin; rEV675 n/a 9/8/2016 Akari Therapeutics Plc

835

Coxsackievirus A21 Cavatak 12/15/2005 Viralytics Limited836

Creatine Creapure 10/11/2005837

creatine Creapure 2/12/2002 Avicena Group, Inc.838

crenolanib n/a 3/18/2011 Treatment of soft tissue sarcoma839

crenolanib n/a 10/31/2012840

crenolanib besylate n/a 12/20/2010 Treatment of malignant glioma841

cridanimod n/a 1/12/2011842 crizotinib Xalkori 10/31/2012 Treatment of neuroblastoma Pfizer, Inc.


Sandler Center for Drug Discovery

Corticotropin-releasing factor, human

Treatment of peritumoral brain edema.

Neurobiological Technologies, Inc.



Treatment of stage II (T4), stage III, and stage IV melanoma


Marathon Pharmaceuticals, LLC


AROG Pharmaceuticals, LLC




Treatment of progesterone receptor negative endometrial cancer in conjunction with progesterone therapy.

Xenetic Biosciences, Inc.


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843crizotinib Xalkori 9/28/2012 Pfizer, Inc.

844n/a 12/9/2015 Treatment of mastocytosis. Patara Pharma, LLC

845

n/a 12/30/1991 ImmuCell Corporation846

cultured skin substitute (CSS) Novaderm 8/22/2016 Regenicin Inc.847

n/a 8/15/2003848

n/a 11/5/2009849

n/a 12/20/2006 Lux Biosciences, Inc.

Treatment of anaplastic large cell lymphoma

cromolyn sodium for inhalation

Cryptosporidium hyperimmune bovine colostrum IgG concentrate

Treatment of diarrhea in AIDS patients caused by infection with Cryptosporidium parvum.

Treatment of burns requiring skin grafting.

cultured, partially T-Cell depleted, allogenic thymic tissue for transplantation

As a therapy for primary immune deficiency resulting from athymia associated with complete DiGeorge Syndrome

Duke University Medical Center

cyclic pyranopterin monophosphate (cPMP)

Treatment of molybdenum cofactor deficiency type A (MoCD)

Alexion Pharmaceuticals, Inc.

Cyclo {{(E,Z)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)nona-6,8-dienoyl}-L-2-aminobytyrl-N-methyl-glycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl}

Treatment and chronic control of non-infectious posterior, intermediate and pan-uveitis


of 400



850


cyclocreatine n/a 6/18/2012 Lumos Pharma852

cyclophosphamide Cyrevia(Tm) 6/17/2011853

cyclophosphamide Cyrevia(Tm) 6/7/2011 Treatment of systemic sclerosis.854

Cyclosporin A Mitogard 10/29/2004 Maas Biolab,LLC855

cyclosporine n/a 2/17/2009856

cyclosporine n/a 2/17/2009857

Cyclosporine n/a 11/25/2003858

Cyclosporine Pluminiq 11/25/2003

cyclo(-y-aminobutyryl-L-phenylalanyl-L-tryptophanyl-D-tryptophanyl-L-lysyl-L-threonly-L-phenylalanyl-N-3-carboxypropyl)-glycine amide, acetate salt

Aspireo Pharmaceuticals Limited

Treatment of creatine transporter deficiency

Prevention of graft versus host disease following allogeneic hematopoietic stem cell transplant

Accentia Biopharmaceuticals, Inc.

Accentia Biopharmaceuticals, Inc.

Treatment of amyotrophic lateral sclerosis and its variants

Prophylaxis of graft-versus-host disease

Sigmoid Pharma Limited

Treatment of graft-versus-host disease

Sigmoid Pharma Limited

Prophylaxis of organ rejection in patients receiving allogeneic lung transplant

APT Pharmaceuticals, Inc.

Treatment of acute rejection in patients requiring allogenic lung transplants

APT Pharmaceuticals, Inc.


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859

n/a 8/1/1991 Allergan, Inc.860

n/a 8/1/1991 Allergan, Inc.861

cyclosporine A n/a 9/30/2008 Santen SAS862

Cyclosporine A n/a 5/4/2007 Santen SAS863

cyclosporine A Nova22007 4/9/2008 Santen SAS864

n/a 12/6/2000865

Cyclosporine ophthalmic Optimmune 11/9/1988 University Of Georgia866

cyclosporine; ciclosporin 11/23/2010867

n/a 12/29/2015 Vical Incorporated

cyclosporine 2% ophthalmic ointment

For use in corneal melting syndromes of known or presumed immunologic etiopathogenesis, including Mooren's ulcer

Cyclosporine 2% ophthalmic ointment

Treatment of patients at high risk of graft rejection following penetrating keratoplasty

Prevention of corneal graft rejection

Treatment of vernal keratoconjunctivitis

Treatment of herpes simplex virus stromal keratitis

Cyclosporine in combination with omega-3 polyunsaturated fatty acids

Prevention of solid organ graft rejection.

RTP Pharma Corporation

Treatment of severe keratoconjunctivitis sicca associated with Sjogren's syndrome.

Neurostat(R)/Ciclomulsion(R)

Treatment of moderate to severe traumatic brain injury.

NeuroVive Pharmaceutical AB

Cyclo{-Asn-Leu-d-Phe-Al[(N5-acetyl-N5-hydroxy-Orn)-(N5-acetyl-N5-hydroxy-Orn)-(N5-hydroxy-Orn)]-} . Al(III)

Treatment of invasive aspergillosis.


of 400



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Cys-His-Ala-Val-Cys n/a 2/14/2008869 Cysteamine Lynovex 9/11/2014 Treatment of cystic fibrosis NovaBiotics Ltd.870

Cysteamine n/a 5/1/1986 Thoene, Jess G., M.D.871

cysteamine n/a 5/9/2008 Horizon Orphan LLC872

cysteamine n/a 9/11/2013 Treatment of pancreatic cancer Horizon Orphan LLC873

cysteamine n/a 8/6/2008874

Adgvcftr.10 3/9/1995 Treatment of cystic fibrosis. GenVec, Inc.875

n/a 1/8/1993 Treatment of cystic fibrosis. Genetic Therapy, Inc.876 cytarabine liposome Depocyt 1/30/2007 Treatment of gliomas Bruce Frankel, MD877

n/a 8/22/2008878

n/a 6/17/2011

For use in conjunction with melphalen for the treatment of malignant melanoma, AJCC stages IIB, IIC, III and IV

Adherex Technologies, Inc.

Treatment of nephropathic cystinosis.


Treatment of neuronal ceroid lipofuscinoses (Batten disease)

Raptor Pharmaceuticals, Inc.

Cystic fibrosis Tr gene therapy (recombinant adenovirus)

Cystic fibrosis transmembrane conductance regulator gene

Cytarabine:daunorubicin liposome injection


Celator Pharmaceuticals, Inc.

cytochrome C, flavin mononucleotide and thiamin diphosphate

Treatment of mitochondrial disorders



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879

n/a 12/17/2014880

n/a 9/23/2006 Vical Inc.881

n/a 6/3/2005882

n/a 1/28/1991 Bayer Corporation883

D-mannitol and L-proline Prodarsan 4/20/2009 DNage B.V.884

d-methadone n/a 6/2/2016

cytochrome P450 isoform 2B1 gene transfected human embryonic kidney 293 cells encapsulated in polymeric cellulose sulphate

Treatment of pancreatic cancer in combination with ifosfamide

PharmaCyte Biotech, Inc.

Cytomegalovirus DNA Vaccine w/Copolymer/Benzalkonium Chloride

For use in prevention of clinically significant CMV viremia, CMV disease and associated complications in at-risk hematopoietic cell transplant and solid organ transplant populations

Cytomegalovirus DNA vaccine with plasmids expressing pp65 and gB genes

Prevention of clinically significant cytomegalovirus (CMV) viremia, CMV disease and associated complications in at-risk hematopoietic cell transplant and solid transplant populations

Astellas Pharma Global Development, Inc.

Cytomegalovirus immune globulin intravenous (human)

For use in conjunction with ganciclovir sodium for the treatment of cytomegalovirus pneumonia in bone marrow transplant patients.

Treatment of Cockayne syndrome


Relmada Therapeutics, Inc.


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885D-peptide Nerofe 2/4/2011

886Pulmadex 10/23/2002 Treatment of cystic fibrosis Demegen, Inc.

887

n/a 11/5/2014888

dabrafenib Tafinlar 2/8/2016889

dabrafenib Tafinler 10/20/2014890

dabrafenib and trametinib 9/1/2016891

dabrafenib and trametinib n/a 10/29/2015892

dacetuzumab n/a 8/13/2004 Treatment of multiple myeloma. Seattle Genetics, Inc.893

dacetuzumab n/a 10/6/2005 Seattle Genetics, Inc.894

dacomitinib n/a 3/3/2015 Pfizer, Inc.


Immune System Key, Ltd

D-peptide of the sequence AKRHHGYKRKFH - NH2

d6-tetrabenazine, deutetrabenazine



Treatment of malignant glioma with BRAF V600 mutation


Treatment of patients with BRAF mutation positive non-small cell lung cancer

Novartis Pharmaceuticals Corp

Tafinlar(R) Capsules A Nd Mekinist(R) Tablets

Treatment of patients with anaplastic thyroid cancer and locally advanced or metastatic papillary thyroid cancer whose tumors harbor a BRAF V600 mutation.


Treatment of patients with BRAF mutation positive non-small cell lung cancer.



Treatment of non-small cell lung cancer with EGFR, HER2, HER4, or DDR2 mutations.


of 400



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dalbavancin Dalvance 3/30/2015896

dantrolene sodium n/a 2/17/2016 Treatment of Wolfram Syndrome897

dantrolene sodium n/a 9/25/2012 Treatment of heat stroke898

Dapsone n/a 11/7/1994899

Dapsone USP Dapsone 1/8/1992900

Dapsone USP Dapsone 12/24/1991901

daratumumab Humax (R) - Cd38 11/9/2015902

daratumumab n/a 8/20/2015903

daratumumab n/a 8/6/2015

Treatment of acute osteomyelitis in children (0 through 16 years of age)

Durata Therapeutics International B.V.

Washington University in St. Louis

Eagle Pharmaceuticals, Inc.

Prophylaxis of toxoplasmosis in severely immunocompromised patients with CD4 counts below 100.

Jacobus Pharmaceutical Company, Inc.

For the combination treatment of Pneumocystis carinii pneumonia in conjunction with trimethoprim.


Prophylaxis for Pneumocystis carinii pneumonia.



Janssen Research and Development, LLC


Janssen Research & Development, LLC




of 400



904Darinaparsin n/a 9/13/2010 Solasia Pharma K.K.

905dasiprotimut-T Biovax Id 6/17/2010

906dasiprotimut-T Biovaxid 10/28/2009

907Daunorubicin liposomal n/a 9/5/2008 Diatos USA, LLC

908davunetide n/a 12/7/2009

909 DCVAC OvCa n/a 5/14/2013 Treatment of ovarian cancer SOTIOS a.s.910

DEAE-rebeccamycin n/a 3/1/2004 Treatment of bile duct tumors Helsinn Healthcare SA911

debrase Debridase 8/20/2003 MediWound, Ltd.912

n/a 9/19/2016 Treatment of sickle cell disease EpiDestiny Inc.913 defactinib n/a 2/12/2015 Treatment of ovarian cancer Verastem, Inc.914

deferiprone n/a 7/31/2008 Treatment of Friedreich's ataxia ApoPharma, Inc.915

deferiprone n/a 9/1/2011 Treatment of superficial siderosis ApoPharma, Inc.916

n/a 1/28/2005917

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Treatment of peripheral T-cell lymphoma.

Treatment of mantle cell lymphoma






Allon Therapeutics, Inc.

Debridement of acute, deep dermal burns in hospitalized patients

decitabine and tetrahydrouridine

deferoxamine starch conjugate

Treatment of acute iron poisoning

Biomedical Frontiers, Inc.

deferoxamine starch conjugate

Treatment of chronic iron overload resulting from conventional transfusional treatment of beta-thalassemia major and sickle cell anemia.



of 400



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defibrotide n/a 1/8/2007919

Defibrotide n/a 7/5/1985 Crinos International920

deflazacort Calcort 9/16/2010921

deflazacort n/a 8/16/2013922

deflazacort n/a 10/22/2015923

dehydrated alcohol n/a 3/16/2012924

dehydrated alcohol Ablysinol 9/11/2013925

Fidelin 8/19/2003 Paladin Labs, Inc.926

n/a 1/29/1997 Pharmadigm, Inc.

For the prevention of hepatic veno-occlusive disease.


Treatment of thrombotic thrombocytopenic purpura.


University of Rochester Medical Center



Treatment of pediatric (0 through 16 years of age) juvenile idiopathis arthritis (JIA) International League of Associations for Rheumatology (ILAR) categories excluding systemic JIA.




Treatment of hypertrophic obstructive cardiomyopathy

Belcher Pharmaceuticals, LLC

Dehydroepiandrosterone (DHEA)

Replacement therapy in individuals with adrenal insufficiency

Dehydroepiandrosterone sulfate sodium

Treatment of serious burns requiring hospitalization.


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n/a 1/28/1997 Pharmadigm, Inc.928

n/a 12/2/2011929

n/a 12/3/2015 Treatment of glioma. GW Research Ltd.930

demcizumab n/a 4/30/2014 Treatment of pancreatic cancer931

n/a 6/7/2010932

dendritic hybrid cell vaccine Neuroblaxin 9/23/2011 Treatment of neuroblastoma933

n/a 1/6/2016 Immune Design Corp.934

denileukin diftitox Ontak 4/30/2010 Eisai, Inc.935

denileukin diftitox n/a 7/12/2013 Eisai Inc.

Dehydroepiandrosterone sulfate sodium

To accelerate the re-epithelialization of donor sites in those hospitalized burn patients who must undergo autologous skin grafting.

delta-1,4,9(11)-pregnatriene-17-alpha,21-dihydroxy-16-alpha-methyl-3,20-dione


ReveraGen Biopharma

delta-9-tetrahydrocannibinol and cannabidiol

OncoMed Pharmaceuticals, Inc.

dendritic cells pulsed with synthetic peptides derived from antigens MAGE1, HER-2, AIM-2,TRP-2, gp100 and interleukin-13 receptor alpha

Treatment of glioblastoma or brain stem glioma

ImmunoCellular Therapeutics Ltd.

Orbis Health Solutions, LLC

dendritic-cell targeting, lentiviral vector encoding the NY-ESO-1 gene





of 400



936denileukin diftitox n/a 6/29/2011 Eisai, Inc.

937

n/a 7/7/2016938

Dermagraft n/a 12/13/2010939

Deslorelin Somagard 11/5/1987940

n/a 10/26/2004 Treatment of pemphigus vulgaris Peptimmune, Inc.941

deutetrabenazine n/a 1/13/2015942

dexamethasone phosphate n/a 12/2/2008943

n/a 7/24/2012 EryDel S.p.A.944

dexanabinol n/a 8/11/2004 Pharmos Corporation945

dexpramipexole n/a 10/11/2007

Treatment of peripheral T-cell lymphoma (PTCL)

deoxythymidine monophosphate and deoxycytidine monophosphate

Treatment of thymidine kinase 2 deficiency.

Columbia University Medical Center

Treatment of epidermolysis bullosa

Shire Regenerative Medicine, Inc.

Treatment of central precocious puberty.


Desmoglein 3 synthetic peptide (PI-0824)

Treatment of Tourette syndrome in the pediatric population (defined as 0 through 16 years of age)

TEVA Pharmaceuticals

Treatment of corneal graft rejection.

EyeGate Pharmaceuticals, Inc.

dexamethasone sodium phosphate encapsulated in autologous erythrocytes

Treatment of ataxia-telangiectasia

For the attenuation or amelioration of the long-term neurological sequelae associated with moderate and severe traumatic brain injury


Knopp Biosciences LLC


of 400



946

dexrazoxane hydrochloride n/a 8/19/2014 Satiscor, LLC947

dextran 1 n/a 3/21/2003 Treatment of cystic fibrosis BCY LifeSciences Inc.948

Dextran 70 Dehydrex 3/5/1990949

Dextran and deferoxamine Bio-Rescue 3/8/1991950

Uendex 10/5/1990951

Dextran sulfate sodium n/a 11/19/1987952

diacerein n/a 10/15/2014953

6/11/1992954

diannexin n/a 10/28/2009

Prevention of cardiomyopathy for chilren and adolescents 0 through 16 years of age treated with anthracyclines

Treatment of recurrent corneal erosion unresponsive to conventional therapy.

Holles Laboratories, Inc.

Treatment of acute iron poisoning.


Dextran sulfate (inhaled, aerosolized)

For use as an adjunct to the treatment of cystic fibrosis.


Treatment of aquired immunodeficiency syndrome.

Ueno Fine Chemicals Industry, Ltd.


Castle Creek Pharmaceuticals

Dianeal peritoneal dialysis solution with 1.1% amino acids

Nutrineal (Peritoneal Dialysis Solution With 1.1% Amino Acid

For use as a nutritional supplement for the treatment of malnourishment in patients undergoing continuous ambulatory peritoneal dialysis.

Baxter Healthcare Corporation

Prevention of ischemia-reperfusion injury in solid organ transplants



of 400



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diazepam (intranasal) n/a 11/16/2015956

diazepam (intranasal) n/a 7/31/2012957

diazepam auto-injector n/a 5/30/2013958

Diazepam buccal soluble film n/a 11/10/2016 MonoSol Rx, LLC959

Diazepen(Tm) 5/26/2016960

diazoxide n/a 12/3/2012 Sedogen, LLC961

diazoxide choline n/a 5/13/2014 Essentialis, Inc.962

Diethyldithiocarbamate Imuthiol 4/3/1986 Treatment of AIDS.

Management of acute repetitive seizures.

Neurelis Pharmaceuticals, Inc.

Management of patients with acute repetitive seizures


Management of selected, refractory patients with epilepsy on stable regimens of antiepileptic drugs, who require intermittent use of diazepam to control bouts of increased seizure activity

Meridian Medical Technologies-a Pfizer subsidiary

Treatment of selected, refractory patients with epilepsy who are on stable regimens of antiepileptic drugs (AED) and who require intermittent use of diazepam to control bouts of increased seizure activity (acute repetitive seizures)

diazepam subcutaneous injection

Treatment of acute repetitive seizures.

Xeris Pharmaceuticals, Inc.

Treatment of Prader Willi Syndrome

Treatment of Prader-Willi Syndrome

Connaught Laboratories


of 400



963

n/a 4/14/2004 CIS-US964

diferuloylmethane n/a 6/13/2003 Treatment of cystic fibrosis965 digitoxin n/a 11/2/2001 Treatment of ovarian cancer SimRx Advisors LLC966

digitoxin n/a 10/18/2001 SimRx Advisors LLC967

digitoxin n/a 5/27/2005 Treatment of cystic fibrosis968

digoxin immune fab (ovine) n/a 2/3/2012 Velo Bio, LLC969

Digoxin immune fab(ovine) Digidote 3/11/1985970

Eurartesim 1/8/2007971

Dihydrotestosterone Androgel -Dht 2/5/1996

diethylenetriaminepentaacetate (DPTA)

For treatment of patients with known or suspected internal contamination with plutonium, americium or curium to increase the rates of elimination.

Allertein Therapeutics, LLC

Treatment of soft tissue sarcomas

Silver Pharmaceuticals

Treatment of severe preeclampsia and eclampsia

Treatment of life-threatening acute cardiac glycoside intoxication manifested by conduction disorders, ectopic ventricular activity and (in some cases) hyperkalemia.

Boehringer Mannheim Corp.

dihydroartemisinin and piperaquine

Treatment of uncomplicated malaria caused by "Plasmodium falciparum," Plasmodium vivax," Plasmodium malariae," or "Plasmodium ovale."


Treatment of weight loss in AIDS patients with HIV-associated wasting.

Besins Internaitonal, US Inc.


of 400



972dimebon n/a 5/12/2009 Medivation, Inc.

973

n/a 11/24/1999974

dimethyl fumarate n/a 9/11/2013 Treatment of Friedreich's Ataxia Gino Cortopassi975

Dimethyl sulfoxide n/a 11/22/1994976

dimethyl sulfoxide n/a 5/9/2008977

Dimethylsulfoxide n/a 4/6/1998978

Dimethylsulfoxide n/a 4/15/1997979

dinaciclib n/a 8/25/2011

Treatment of Huntington's Disease.

Dimerizing drug that binds to mutated Fas protein/drug-binding domain fusion protein (FKBP)

Treatment of acute graft-versus-host disease in patients undergoing bone marrow transplantation.

Bellicum Pharmaceuticals, Inc.

Treatment of increased intracranial pressure in patients with severe, closed-head injury, also known as traumatic brain coma, for whom no other effective treatment is available.

Abela Pharmaceuticals, Inc.

For use in combination with antimicrobial drugs for the treatment of drug resistant tuberculosis

Abela Pharmaceuticals, Inc.

Treatment of palmar-plantar erythrodysethesia syndrome.

Cancer Technologies, Inc.

Topical treatment for the prevention of soft tissue injury following extravastion of cytotoxic drugs.

Cancer Technologies, Inc.


Merck Sharp & Dohme Ltd.


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980

Alec 7/28/1988 Forum Products, Inc.981

diphenylcyclopenone n/a 6/13/2003 Lloyd E. King, Jr.982

Diphenylcyclopropenone gel Samcyprone (Tm) 4/15/2015983

dipraglurant n/a 12/29/2015 Addex Pharma SA984

Immther 3/1/1990985

Disodium clodronate n/a 6/16/1993986

Bonefos 3/5/1990987

Disufenton sodium n/a 8/22/2016 Oblato, Inc.

Dipalmitoylphosphatidylcholine /phosphatidylglycerol

Prevention and treatment of neonatal respiratory distress syndrome.

Treatment of chronic severe forms of alopecia areata (Alopecia Totalis [AT]/Alopecia Universalis [AU])

Treatment of malignant melanoma stage IIB to IV

RXi Pharmaceuticals Corp.

Treatment of levodopa-induced dyskinesias

Disaccharide tripeptide glycerol dipalmitoyl

Treatment of pulmonary and hepatic metastases in patients with colorectal adenocarcinoma.

ImmunoTherapeutics, Inc.

Treatment of hypercalcemia of malignancy.

Discovery Experimental & Development, Inc.

Disodium clodronate tetrahydrate

Treatment of increased bone resorption due to malignancy.

Anthra Pharmaceuticals, Inc.



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988

n/a 9/19/2016 Treatment of glioma.989


n/a 2/6/2014 ViroMed Co., Ltd.991

n/a 12/13/2010 Treatment of multiple myeloma.992

n/a 7/24/2012993

n/a 7/24/2012

disulfide-stabilized single-chain variable region fragment of the anti-EGFR wild type/EGFRvIII dual specificity monoclonal antibody with variable fragments fused to a truncated version of the Pseudomonas exotoxin A, PE38, and KDEL

Darell D. Bigner, MD, PhD

DNA plasmid expressing diphtheria toxin triggered by the presence of oncofetal gen H19

BioCancell Therapeutics Ltd.

DNA plasmid vector (pCK-HGFX7) expressing human hepatocyte growth factor


DNA plasmid vector expressing eIF5Ak50

Senesco Technologies, Inc.

DNA plasmid vector expressing eIF5Ak50R protein, siRNA directed against the nastive eIF5A mRNA, and PEI (polyethyleneimine)

Treatment of diffuse large B cell lymphoma


DNA plasmid vector expressing eIF5Ak50R protein, siRNA directed against the native eIF5A mRNA, and PEI (polyethyleneimine)




of 400



994

n/a 4/4/2005 Treatment of ovarian cancer. Celsion Corporation995

Leuvectin 4/28/2000 Vical Incorporated996

O-Vax 9/21/2000997

docosahexaenoic acid n/a 4/27/2015 Treatment of sickle cell disease998

docosahexaenoic acid n/a 6/1/2015999

docosahexaenoic acid, DHA n/a 12/17/20141000

n/a 2/11/2016 Treatment of sickle cell disease NuvOx Pharma1001

n/a 12/2/2015 NuvOx Pharma1002

domperidone n/a 9/2/2011

DNA plasmid vector expressing human IL-12 gene

DNA-lipid complex (DMRIE/DOPE)/plasmid vector (VCL-1102, Vical) expressing human interleukin-2


DNP-Modified autologous tumor vaccine

Adjuvant therapy for the treatment of ovarian cancer

AVAX Technologies, Inc.

Sancilio & Company, Inc.

Treatment of short bowel syndrome

Sancilio and Company, Inc.


Sancilio and Company, Inc.

dodecafluoropentane emulsion

dodecafluoropentane emulsion (DDFPe)

Radiosensitizer to be used during radiation treatment of glioblastoma multiforme (GBM).

Treatment of hypoprolactinemia in breastfeeding mothers, and in some hypoprolactinemic conditions following the use of cabergoline or bromocriptine in mothers who wish to initiate or return to breastfeeding

Thomas W. Hale, RPh, PhD


of 400



1003

Doripenem n/a 7/16/2004 Shionogi, Inc.1004

n/a 6/9/20151005

n/a 1/26/2015 Treatment of pancreatic cancer Silenseed Ltd1006


dovitinib n/a 9/26/20131008

DOXO-EMCH n/a 4/18/2011 CytRx Corporation1009

doxofylline n/a 2/14/2014 Treatment of bronchiectasis1010

doxorubicin n/a 8/25/2009 Delcath Systems, Inc.1011

doxorubicin n/a 4/6/2015 Louis D. Falo, Jr.

Treatment of bronchopulmonary infection in patients with cystic fibrosis who are colonized with Pseudomonas aeruginosa or Burkholderia cepacia.

double stranded oligomer AD00370 RNA interference-based liver targeted therapeutic

Treatment of Alpha-1 Antitrypsin deficiency

Arrowhead Research Corporation

double stranded RNA which targets the mutated KRAS oncogene

Double-stranded DNA plasmid carrying the gene for the diphtheria toxin A (DT-A) chain

BioCancell Therapeutics Israel Ltd.

Treatment of adenoid cystic carcinoma


Treatment of adenocarcinoma of the pancreas.

Alitair Pharmaceuticals, Inc.




of 400



1012

n/a 10/7/2005 Supratek Pharma Inc.1013

Doxorubicin Transdrug 3/14/2005 BioAlliance Pharma1014

n/a 2/20/2008 Treatment of gastric cancer Supratek Pharma, Inc.1015

DPX-Survivac n/a 7/14/2015 Treatment of ovarian cancer.1016

n/a 8/7/2014 Birken AG1017 Duramycin n/a 12/11/1997 Treatment of cystic fibrosis. Lantibio, Inc.1018

dusquetide n/a 8/10/2016 Soligenix, Inc.1019

duvelisib n/a 4/15/20131020

duvoglustat hydrochloride n/a 6/18/2007 Treatment of Pompe disease1021

Dynamine n/a 10/16/1991 Mayo Foundation1022

Dynamine n/a 2/5/1990 Mayo Foundation1023

E-selectin antagonist n/a 5/13/2015 GlycoMimetics, Inc.

Doxorubicin HCl with pluronic L-61 and pluronic F-127

Treatment of esophageal carcinoma

doxorubicin PIHCA nanoparticles


doxorubicin with pluronics F-127 and L-61

Immunovaccine Technologies, Inc.

dry extract from Betulae Cortex (birch bark)


Treatment of macrophage activation syndrome

Treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma

Infinity Pharmaceuticals

Amicus Therapeutics, Inc

Treatment of hereditary motor and sensory neuropathy type I (Charcot-Marie-Tooth disease).

Treatment of Lambert Eaton myasthenic syndrome.

Treatment of acute myeloid leukemia (AML)


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1024

n/a 2/8/20161025

echinomycin n/a 5/21/2015 OncoImmune, Inc.1026

echothiophate iodide n/a 6/2/2014 Treatment of Stargardt's disease Makindus, Inc.1027

ecopipam hydrochloride n/a 7/21/20091028

ecopipam hydrochloride n/a 9/29/20101029

eculizumab Soliris 6/24/20131030

eculizumab n/a 6/12/2014 Treatment of Myasthenia Gravis.1031

eculizumab n/a 3/5/2001

Echinocandin B,1-[(4R,5R)-4-hydroxy-N2-[[4’’-(pentyloxy)[1,1’:4’,1’’-terphenyl]-4-yl]carbonyl]-5-[2-(trimethylammonio)ethoxy]-L-ornithine]-4-[(4S)-4-hydroxy-4-(4-hydroxyphenyl)-L-allothreonine]

Treatment of candidemia and invasive candidiasis infections caused by susceptible Candida spp.

Cidara Therapeutics, Inc.


Symptomatic treatment of self injurious behaviors in patients with Lesch-Nyhan disease.

Psyadon Pharmaceuticals, Inc.

Treatment of Tourette's syndrome in children 0-16 years old.

Psyadon Pharmaceuticals, Inc.

Treatment of neuromyelitis optica



Treatment of idiopathic membranous glomerular nephropathy



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1032


Eculizumab n/a 9/21/2000 Treatment of dermatomyositis1034


edaravone n/a 5/12/20151036

edaravone n/a 3/12/2015 Treeway B.V.1037

Edotreotide Onalta(Tm) 7/28/20051038

efaproxiral n/a 7/28/20041039

Efdispo (tm) Efdispo (Tm) 1/15/2013 Treatment of Ewings Sarcoma.1040

eflornithine n/a 2/4/20111041

Eflornithine n/a 9/29/2006 Treatment of anaplastic glioma

Treatment of Shiga-Toxin producing escherichia coli hemolytic uremic syndrome



Prevention of delayed graft function after renal transplantation



Mitsubishi Tanabe Pharma Corporation


Treatment of somatostatin receptor-positive neuroendocrine gastroenteropancreatic tumors

Molecular Insight Pharmaceuticals, Inc. (Progenics Subsidiary)

Adjunct to whole brain radiation therapy for the treatment of brain metastases in patients with breast cancer

Allos Therapeutics, Inc.

TDP Biotherapeutics, Inc.

Treatment of Familial Adenomatous Polyposis

Cancer Prevention Pharmaceuticals

Orbus Therapeutics, Inc.


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eflornithine n/a 11/23/2010 Treatment of neuroblastoma1043

eflornithine HCL n/a 4/7/2015 Treatment of gastric cancer1044

eflornithine plus sulindac n/a 1/22/20131045

eicosapentaenoic acid n/a 3/8/20111046

elacytarabine n/a 6/18/2008 Clavis Pharma ASA1047

Elcatonin n/a 9/25/1995 Innapharma, Inc.1048

Elesclomol n/a 12/18/20071049

eltoprazine HCl n/a 2/8/20161050

emodepside n/a 9/13/20161051

emricasan n/a 11/20/2013

Cancer Prevention Pharmaceutical, Inc.

Cancer Prevention Pharmaceuticals, Inc.

Treatment of familial adenomatous polyposis

Cancer Prevention Pharmaceuticals, Inc.


S.L.A. Pharma Ltd. (UK)


Intrathecal treatment of intractable pain.

Treatment of metastatic melanoma in combination with paclitaxel

Synta Pharmaceuticals Corporation

Treatment of levodopa-induced dyskinesia associated with Parkinson's disease.


Treatment of onchocerhiasis ("river blindness") caused by the filarial nematode onchocerca volvulus


Treatment of liver transplant recipients with reestablished fibrosis to delay the progression to cirrhosis and end stage liver disease

Conatus Pharmaceuticals Inc.


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1052Enadoline hydrochloride n/a 1/28/1997 Treatment of severe head injury.

1053

Betarx 7/5/1995 VivoRx1054

n/a 8/19/2015 Seres Health, Inc.1055

enchochleate amphotericin B n/a 1/10/20141056

encochleated amikacin n/a 3/3/20161057

encorafenib n/a 11/19/20131058

encorafenib + binimetinib n/a 11/19/2013 Array BioPharma, Inc.1059

n/a 1/21/2016 ENB Therapeutics, LLC1060

n/a 5/10/2016 SCYNEXIS, Inc.1061

n/a 2/6/20141062

eniluracil n/a 12/15/2005

Warner-Lambert Company

Encapsulated porcine islet preparation

Treatment of type I diabetic patients who are already on immunosuppression.

encapsulated spores from fecal microbiota

Treatment of recurrent Clostridium difficile infection (CDI)


Aquarius Biotechnologies, Inc.

Treatment of non-tuberculous mycobacteria (NTM) infections

Aquarius Biotechnologies, Inc.

Treatment of Stage IIB-IV melanoma positive for BRAF mutation

Array BioPharmas, Inc.

Treatment in Stage IIB-IV melanoma positive for the BRAF mutation.

Endothelin receptor B antagonist

Treatment of malignant melanoma Stages IIB to IV.

enfumafungin derivative B-(1,3)-D-glucan synthestis inhibitor

Treatment of invasive Candida infections, including candidemia

Engineered variant of recombinant human fibroblast growth factor 19


NGM Biopharmaceuticals, Inc.


Adherex Technologies, Inc.


of 400



1063ensituximab n/a 10/21/2010 Treatment of pancreatic cancer.

1064

n/a 12/22/2014 Treatment of neuroblastoma Ignyta, Inc.1065

enzastaurin n/a 3/4/20091066

Enzastaurin n/a 9/19/20051067

epacadostat n/a 2/11/2016 Incyte Corporation1068

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Epoetin alfa n/a 12/20/19931070

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Epoetin beta Marogen 10/22/1987 Chugai-USA, Inc.

Neogenix Oncology, Inc.

entrectinib;N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methylpiperazin-1yl)-2-(tetrahydro-2H-pyran-4-ylamino)benzamide


Denovo Biopharma LLC


Denovo Biopharma LLC

Treatment of stage IIB-IV melanoma.

Epidermal growth factor (human)

For acceleration of corneal epithelial regeneration and the healing of stromal tissue in the condition of non-healing corneal defects.


Johnson & Johnson Pharmaceutical Research & Dev.,

Treatment of anemia associated with end stage renal disease.

R. W. Johnson Pharmaceutical Research Institute

Treatment of HIV associated anemia related to HIV infection or HIV treatment.




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1073epratuzumab n/a 9/30/2008 Immunomedics, Inc.

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1075Eprodisate Kiacta(Tm) 4/6/1999

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n/a 6/12/2014 FFCanVac Pte Ltd1077

eptifibatide and iloprost n/a 4/20/2012 Treatment of purpura fulminans Thrombologic1078

erdosteine n/a 12/20/2013 Treatment of bronchiectasis.1079

Erlotinib Hydrochloride Tarceva 7/18/2003 Treatment of malignant gliomas Genentech, Inc1080

n/a 8/19/19871081

estradiol Gel n/a 10/31/20061082

etarfolatide n/a 2/16/2000 Endocyte, Inc.


Treatment of non-Hodgkin's lymphoma

Treatment of secondary amyloidosis

C. T. Development America, Inc.

Epstein-Barr virus-specific autologous cytotoxic T lymphocytes

Treatment of Epstein-Barr virus positive head and neck cancers (which includes nasopharyngeal carcinoma)

Alitair Pharmaceuticals, Inc.

Erythropoietin (recombinant human)


McDonnell Douglas Corp

Estrogen replacement therapy in females with Turner syndrome

Ascend Therapeutics US, LLC

For the identification of ovarian carcinomas


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ethanolamine Ethamolin 1/17/2014 QOL Medical, LLC1084

Ethyl eicosapentaenoate n/a 4/6/2000 Laxdale Ltd.1085

Etiocholanedione n/a 11/3/1995 Treatment of aplastic anemia. SuperGen, Inc.1086

Etiocholanedione n/a 5/7/1996 SuperGen, Inc.1087

etirinotecan pegol n/a 4/18/2011 Treatment of ovarian cancer. Nektar Therapeutics1088

etrolizumab n/a 8/22/2016 Genentech, Inc.1089

everolimus Afinitor 7/23/20121090

everolimus n/a 6/2/20141091

everolimus ointment n/a 9/10/20151092

evinacumab n/a 2/8/2016

Prophylactic use in pediatric patients (age 0 through 16 years) with esophageal varices that are at risk of bleeding to obliterate varices and to prevent bleeding


Treatment of Prader-Willi syndrome.






Topical treatment of Tuberous Sclerosis Complex-related skin lesions

Aucta Pharmaceuticals, LLC

Treat of homozygous familial hypercholesterolemia.

Regeneron Pharmaceuticals, Inc.


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Prochymal(R) 12/14/2005 Mesoblast, Inc.1094

n/a 5/8/2014 iCell Science AB1095

Prochymal(R) 4/30/2010 Mesoblast, Inc.1096

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exendin-(9-39) n/a 6/1/20111098

Exisulind n/a 2/14/19941099

n/a 11/5/2009

Ex vivo cultured adult human mesenchymal stem cells

Treatment of acute graft versus host disease

ex vivo cultured human mesenchymal stromal cells

Prevention of graft rejection following solid organ transplantation

ex-vivo cultered adult human mesenchymal stem cells

Treatment of Type 1 diabetes patients with residual beta cell function

ex-vivo expanded autologous bone marrow-derived mesenchymal stem cells


TCA Cellular Therapy, LLC

Treatment of congential hyperinsulinenic hypoglycemia and other causes of hyperinsulinemic hypoglycemia in adults and children

The Children's Hospital of Philadelphia

For the suppression and control of colonic adenomatous polyps in the inherited disease adenomatous polyposis coli.

OSI Pharmaceuticals, Inc.

Exon 44 specific phosphorothioate oligonucleotide

Treatment of Duchenne Muscular Dystrophy in patients who have a mutation correctable by skipping of exon 44of the dystrophin gene.



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n/a 8/25/20091102

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Treatment of Duchenne Muscular Dystrophy patients bearing mutations that can be corrected by skipping exon 45



Treatment of Duchenne Muscular Dystrophy.


Exon 52 specific phosphorothiate oligonucleotide



exon 53 specific phosphorothioate oligonucleotide

treatment of Duchenne Muscular Dystrophy patients bearing mutations that can be corrected by skipping exon 53





expanded allogeneic human dermal fibroblasts in hypothermosol(r)-FRS

Treatment of Dystrophic Epidermolysis Bullosa.

expanded human allogeneic neural retinal progenitor cells extracted from neural retina



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n/a 11/19/2012 Treatment of sickle cell disease Invenux, LLC1109

ezatiostat hydrochloride Telintra 1/9/2013 Telik, Inc.1110

n/a 3/8/19951111

n/a 1/10/2014 Treatment of hemophilia A Genentech1112

n/a 5/21/20031113

Fampridine Neurelan 6/2/19971114

n/a 5/2/20161115 farletuzumab n/a 6/16/2006 Treatment of ovarian cancer Morphotek, Inc.1116

fecal microbiota n/a 3/10/2014 Rebiotx, Inc.1117

fenfluramine HCI Brabafen 12/20/2013 Zogenix, Inc.

Extract of sea cucumber, sea sponge, shark fin, sea urchin, and sargassum grass

Unicorn Pacific Corporation

extract of sorghum bicolor extract


Facilitated DNA Plasmid Vaccine

Treatment of cutaneous T cell lymphoma.

Wyeth-Lederle Vaccines and Pediatrics

factor VIII mimetic bispecific antibody

Factor XIII [A2] homodimer, recombinant DNA origin

Treatment of congenital FXIII deficiency

Novo Nordisk Pharmaceuticals, INc.

Treatment of chronic, incomplete spinal cord injury.


Fancalen (lentiviral vector containing the Fanconi anemia-A (FANCA) gene

Treatment of Fanconi anemia type A patients.

Centro de Investigacion Biomedica en Red (CIBER)

Treatment of recurrent Clostridium difficile infection (Clostridium difficile gastrointestinal disease)

For the Treatment of Dravet Syndrome


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1118Fenobam hydrochloride n/a 11/20/2006 Treatment of fragile X syndrome Neuropharm, Ltd.

1119fenretinide n/a 9/4/2013 CerRx, Inc.

1120fenretinide n/a 2/1/2007 Cancer Research UK

1121fenretinide n/a 9/4/2013 CerRx, Inc.

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Fenretinide n/a 4/7/2010 McGill University1123

Fenretinide n/a 10/5/2005 Treatment of neuroblastoma1124

n/a 6/26/2003 Degussa AG1125

ferumoxytol n/a 4/6/2012 ArsNova Partners, LLC1126

ferumoxytol Feraheme 4/29/2011


Treatment of Ewing's sarcoma family of tumors.


Treatment of Pseudomonas aeruginosa lung infections in cystic fibrosis patients


ferric hexacyanoferrate (II) "Prussian Blue"

Treatment of patients with known or suspected internal contamination with radioactive or non-radioactive cesium or thallium

For use in magnetic resonance imaging to assess, and monitor treatment of solid tumor malignancies previously diagnosed in pediatric patients (age 16 years and younger)

For use in MR imaging for the mangement of brain tumors

Edward A. Neuwelt, MD


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ferumoxytol n/a 10/7/20111128

fexinidazole n/a 4/4/20161129

fialuridine n/a 7/24/19921130

n/a 2/1/2007 Kuros Biosurgery AG1131

Fibrinogen (human) n/a 8/23/19951132

n/a 9/5/1988 Melville Biologics, Inc.1133

Fibronectin Peptide n/a 6/29/2011

For use in magnetic resonance imaging in brain metastases

Oregon Health & Science University

Treatment of human African trypanosomiasis (HAT) or sleeping sickness

Sanofi US Services, Inc.

Adjunctive treatment of chronic active hepatitis B.

Oclassen Pharmaceuticals, Inc.

Fibrin-based agent containing a N-terminally modified parathyroid hormone fragment TGplPTH1-34

Treatment of solitary (unicameral) bone cysts

For the control of bleeding and prophylactic treatment of patients deficient in fibrinogen.


Fibronectin (human plasma derived)

Treatment of non-healing corneal ulcers or epithelial defects which have been unresponsive to conventional therapy and the underlying cause has been eliminated.

Prevention of burn injury progression of acute, deep dermal burns in hospitalized patients.

NeoMatrix Therapeutics, Inc.


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fidaxomicin Dificid 12/13/20101135

filanesib n/a 5/6/2014 Treatment of multiple myeloma. Array BioPharma, Inc.1136

filgrastim n/a 1/27/20151137

filociclovir n/a 11/29/2010 Microbiotix, Inc.1138

fingolimod n/a 4/30/20101139

firtecan pegol n/a 4/18/2011 Treatment of neuroblastoma.1140

n/a 10/19/20161141

n/a 9/19/2016 Treatment of narcolepsy Theranexus S.A1142

n/a 11/23/20101143

florilglutamic acid n/a 5/11/2016 Piramal Imaging S.A.1144

Floxuridine, FUDR n/a 12/22/2004 Franco Muggia, M.D.

Treatment of pediatric Clostridium difficile infection

Optimer Pharmaceuticals, Inc.

Treatment of amyotrophic lateral sclerosis (ALS)

Neurovision Pharma GmbH

Treatment of active cytomegalovirus infections

Treatment of chronic inflammatory demyelinating polyneuropathy

Novartis Pharmaceutical Corporation

Enzon Pharmaceuticals, Inc.

fixed dose combination formulation of macitentan and tadalafil


Actelion Clinical Research, Inc.

fixed dose combination of modafinil and flecainide

FliC Flagellin Deletion Variant TLR5 Agonist

Prevention of death following a potentially lethal dose of total body irradiation during or after a radiation disaster

Cleveland BioLabs, Inc.

Diagnostic for the management of glioma

Intraperitoneal treatment of gastric cancer.


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flubendazole n/a 1/23/20141146

flubendazole n/a 10/25/20131147

n/a 4/7/2015 For the diagnosis of glioma1148

Fludarabine phosphate Fludara 4/18/19891149

flunarizine Sibelium 1/6/19861150

flunarizine n/a 6/24/20131151

flunarizine n/a 7/20/20161152

Fluorouracil n/a 4/18/1990

Treatment of lymphatic filariasis caused by nematodes of the family Filariodidea, in children and adults.

Janssen Research and Development, LLC

Treatment of onchocerciasis caused by Onchocerca volvulus


fluciclovine (18F)(anti-1-amino-3-fluorocyclobutane-1-carboxylic acid, labelled with Fluorine-18)

Blue Earth Diagnostics Ltd.

Treatment and management of patients with non-Hodgkins lymphoma.

Berlex Laboratories, Inc.

Treatment of alternating hemiplegia.

Janssen Research Foundation

Treatment of alternating hemiplegia


Treatment of hemiplegic migraine

Xenon Pharmaceuticals, Inc.

For use in combination with interferon alpha-2a, recombinant, for the treatment of advanced colorectal carcinoma.



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Fluorouracil n/a 10/27/19891154

Fluorouracil n/a 6/29/2000 Ethypharm SA1155

Fluoxetine Prozac 4/14/2004 Hollander, Eric MD1156 Fluoxetine Prozac 4/30/1999 Treatment of autism. Neuropharm, Ltd.1157

fluticasone propionate n/a 1/19/20111158

fluticasone propionate n/a 12/29/20151159

n/a 6/8/20161160

n/a 6/8/20161161

fosbretabulin tromethamine n/a 12/29/20151162

fosbretabulin tromethamine n/a 6/8/2016 Treatment of glioma1163

fosfomycin/tobramycin n/a 11/28/2008

For use in combination with interferon alpha-2a, recombinant, for the treatment of esophageal carcinoma.



Treatment of body dysmorphic disorder in children and adolescents

Treatment of pediatric and adult eosinophilic esophagitis

Adare Pharmaceuticals, Inc.

Treatment of eosinophilic esophagitis

Banner Life Sciences, LLC

folate binding protein peptide: Glu-Ile-Trp-Thr-His-Ser-Tyr-Lys-Val

Treatment (including prevention of recurrence) of ovarian cancer

Galena Biopharma, Inc.

Folate Binding Protein Peptide: Glu-Ile-Trp-Thr-Phe-Ser-Thr-Lys-Val

Treatment (including prevention of recurrence) of ovarian cancer

Galena Biopharma, Inc.




Treatment of pulmonary infections associated with cystic fibrosis

CURx Pharmaceuticals, Inc.


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fostamatinib disodium n/a 8/25/20151165

FTV1+GDP-fucose n/a 3/18/20111166

n/a 9/22/2008 Treatment of Ewing's sarcoma1167

Ni-0501 3/26/2010 NovImmune S.A.1168

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G17DT Immunogen Gastrimmune(Tm) 7/10/2002 Cancer Advances, Inc.

Treatment of immune thrombocytopenic purpura

Rigel Pharmaceuticals, INc.

To improve homing to bone (treatment of myeloablation) in patients receiving hematopoietic stem cell transplantation.

America Stem Cell, Inc.

Full Phosphorothioate Antisense Oligonucleotide against EWS-Fli-1 nanoparticles

The Cure Our Children Foundation

Fully human anti-interferon gamma monoclonal antibody

Treatment of hemophagocytic lymphohistiocytosis

fully human IgG2 monoclonal antibody that binds insulin receptors

Treatment of congenital hyperinsulinism

fusion protein analog with recombinant human growth hormone (rhGH) at once-a-month dosing

Treatment of growth hormone deficiency

Fusion protein consisting of human immunoglobim G1 constant region Fc region fused to the human receptor binding domain of ectodysplasin-A1

Treatment of X-linked hypohidrotic ectodermal dysplasia

Edimer Pharmaceuticals, Inc.

Treatment of adenocarcinoma of the pancreas


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1172G17DT Immunogen Gastrimmune(Tm) 7/18/2002 Treatment of gastric cancer Cancer Advances, Inc.

1173gabapentin Neurontin 7/5/1995

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Gallium (68Ga) edotreotide Somakit Toc 7/1/20151175

n/a 10/25/20131176

Gamma hydroxybutyrate n/a 12/3/19871177

Gammalinolenic acid n/a 7/27/1994 Zurier, Robert B. M.D.1178

ganaxolone n/a 3/24/20151179

ganaxolone n/a 4/14/2016 Treatment of status epilepticus.1180

Ganaxolone n/a 5/25/1994 Treatment of infantile spasms.1181

ganitumab n/a 11/23/2010 Treatment of pancreatic cancer. Nantcell1182

n/a 7/7/2009 Treatment of pancreatic cancer Astrimmune Ltd.



Diagnostic for the clinical management of neuroendocrine tumors.

Advanced Accelerator Applications, USA

Gallium-68 (DOTA0-Phel-Tyr3)octreotide

The management of neuroendocrine tumors

University of Iowa Hospital & Clinics

Treatment of narcolepsy and the auxiliary symptoms of cataplexy, sleep paralysis, hypnagogic hallucinations and automatic behavior.

Biocraft Laboratories, Inc.

Treatment of juvenile rheumatoid arthritis.

Treatment of Protocadherin 19 (PCDH19) female epilepsy.

Marinus Pharmaceuticals, Inc.



Gastrin 17C Diphtheria Toxoid Immunogen


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gemcabene n/a 2/6/20141184

gemcitabine n/a 12/30/2015 TARIS Biomedical LLC1185

gemcitabine n/a 1/11/2016 InnoPharmax, Inc.1186

gemcitabine ready-to-use n/a 6/24/2015 Treatment of pancreatic cancer1187

gemcitabine ready-to-use n/a 6/24/2015 Treatment of ovarian cancer1188

n/a 2/4/2009 Memgen, LLC1189

n/a 4/29/2002 Treatment of malignant glioma Aettis, Inc.1190

n/a 12/11/1997 Treatment of Crohn's disease.1191

Geneticin n/a 6/6/2005 Treatment of amoebiasis.1192

gentamicin C2 congener n/a 3/29/2016 Treatment of cystic fibrosis


Gemphire Therapeutics, Inc.

Treatment of upper tract urothelial carcinoma


Sun Pharmaceutical Industries Ltd.

Sun Pharmaceutical Industries Ltd.

gene encoding chimeric CD40 ligand


genetically engineered herpes simplex virus (G207)

Genetically engineered human recombinant IgG4 monoclonal antibody directed against human TNF alpha

Celltech Chiroscience Limited

ProcesScience, Inc (PSI)

La Jolla Pharmaceuticals Company


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Septopal 1/31/19911194

Gentamicin liposome injection Maitec 7/10/19901195

gevokizumab n/a 7/27/2010 Treatment of Behcet's disease XOMA (US) LLC1196

gevokizumab n/a 2/21/2014 XOMA (US) LLC1197

gevokizumab n/a 8/20/2012 XOMA (US) LLC1198

Girentuximab Rencarex 3/22/20011199

givinostat n/a 4/12/2013 Italfarmaco SpA1200

glatiramer acetate Copaxone 11/14/20071201

Copaxone 6/5/20011202

n/a 6/8/2016 AMMTeK

Gentamicin impregnated PMMA beads on surgical wire

Treatment of chronic osteomyelitis of post-traumatic, postoperative, or hematogenous origin.

Lipha Pharmaceuticals, Inc.

Treatment of disseminated Mycobacterium avium-intracellulare infection.

Liposome Company, Inc.

Treatment of pyoderma gangrenosum

Treatment of non-infectious intermediate, posterior or pan uveitis, or chronic non-infectious anterior uveitis


Wilex Biotechnology GmbH

Treatment of Duchenne Muscular Dystrophy and Becker Muscular Dystrophy

Treatment of amyotrophic lateral sclerosis (ALS).

Teva Neurosciences, Inc.

Glatiramer acetate for injection

Treatment of primary-progressive multiple sclerosis

Teva Pharmaceuticals USA

glibentek (glibenclamide oral suspension)

Treatment of neonatal diabetes (monogenic forms of diabetes that present in infancy)


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1203n/a 1/12/2011 Treatment of glioma.

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glucagon n/a 12/5/2012 Biodel, Inc.1205

glucagon infusion G-Pump (Tm) 9/25/20141206

glufosfamide n/a 9/18/20061207


glyburide n/a 9/29/20151209

glyburide n/a 2/8/20161210

glycafilin n/a 8/22/20081211

Glyceryl tri (4-phenylbutyrate) n/a 5/24/2005 Ucyclyd Pharma, Inc1212

n/a 2/14/1995 Moser, Hugo W. M.D.1213

glycopyrrolate 2% n/a 6/17/2010 Treatment of Frey's syndrome

glioma derived cell lysates and irradiated cells

Epitopoietic Research Corp.

Prevention of hypoglycemia in the congenital hyperinsulinism population

Prevention of chronic, severe hypoglycemia related to congential hyperinsulinism

Xeris Pharmaceuticals, Inc.

For treatment of pancreatic cancer.


Glutathione pegylated liposomal doxorubicin hydrochloride

to-BBB technologies BV


Remedy Pharmaceuticals, Inc.

Treatment of acute subarachnoid hemorrhage

Remedy Pharmaceuticals, Inc.

Prevention of delayed graft function after solid organ transplantation

ProtAffin Biotechnologie AG


Glyceryl trioleate and glyceryl trierucate

Treatment of adrenoleukodystrophy.

Wellesley Therapeutics, Inc.


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n/a 9/27/2012 Cytheris, Inc.1215

n/a 10/23/2013 Treatment of Fragile X Syndrome1216

n/a 2/11/2015 Treatment of Rett syndrome1217

Proenzy 4/30/20101218

GNE Lipoplex n/a 11/13/2008 Gradalis, Inc.1219

GNE plasmid(H001) n/a 3/26/2010 HIBM Research Group1220

golimumab Simponi 3/16/2012 Janssen Biotech, Inc.1221

golimumab Simponi Aria 4/2/20151222

golnerminogene pradenovec Tnferade(Tm) Biologic 10/28/2009 Treatment of pancreatic cancer. GenVec, Inc.1223

Gossypol n/a 10/22/19901224

n/a 3/25/1997 Genzyme Corporation1225

n/a 8/27/2008 Treatment of cystic fibrosis Savara Inc.

glycosylated recombinant human interleukin-7

Treatment of progressive multifocal leukoencephalopathy

glycyl-L-2-methylprolyl-L-glutamic Acid

Neuren Pharmaceuticals, Ltd.

glycyl-L-2-methylpropyl-L-glutamic acid

Neuren Pharmaceuticals, Ltd.

Glyeraldehyde-3-phosphate dehydrogenase

Treatment of pediatric multiple sclerosis

BPT Pharmaceuticals, Inc.

Treatment of hereditary inclusion body myopathy-2

Treatment of hereditary inclusion body myopathy type 2


Treatment of polyarticular juvenile idiopathic arthritis in patients 0 through 18 years of age.


Treatment of cancer of the adrenal cortex.

Reidenberg, Marcus M. M.D.

Gp100 adenoviral gene therapy


granulocyte macrophage colony stimuling factor


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n/a 7/24/2013 Treatment of soft tissue sarcoma Oncos Therapeutics1227

n/a 8/7/19891228

n/a 2/23/20161229

guadecitabine n/a 9/29/20151230

guanfacine Tenex 8/5/1999 Treatment of fragile X syndrome.1231

guanfacine and amphetamine n/a 3/17/2016 Genco Sciences, LLC1232

gusperimus trihydrochloride n/a 6/29/2011 Nordic Group B.V.1233

GVAX melanoma n/a 12/23/2010 Aduro BioTech, Inc.1234

gylceryl tri (4-pheynlybutyrate) n/a 9/3/2009

granulocyte-macrophage colony stimulating factor-coding oncolytic adenovirus, Ad5/3-D24-GMCSF

Growth hormone releasing factor

For the long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion.

Valeant Pharmaceuticals North America

growth hormone releasing hormone, 1-44 human amide


Hollenbeck Pharmaceuticals, Inc.


Astex Pharmaceuticals, Inc.

Watson Laboratories, Inc.

Treatment of pediatric patients with Tourette's syndrome (0 through 16 years of age)

Treatment of Wegener's granulomatosis

Treatment of stage IIb to IV melanoma

For intermittent or chronic treatment of patients with cirrhosis and any grade hepatic encephalopathy.

Horizon Therapeutics, Inc.


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n/a 11/3/2016 Treatment of acromegaly Amryt Research Ltd.1236

n/a 12/22/20111237 H-Leu-Pro-Pro-Ser-Arg-OH n/a 9/20/2012 Treatment of Kaposi sarcoma Immuno Tech, Inc.1238

n/a 5/14/2013 NoNO, Inc.1239

n/a 4/11/2014 NoNO, Inc.1240

Halofuginone Stenorol 2/7/2000 Treatment of systemic sclerosis.1241

halofuginone hydrobromide n/a 10/13/20111242

Hanferon Hanferon 3/9/2012 Treatment of Behcet's disease

H-(4-amino-3-iodo)-D-Phe-c[Cys-(3-iodo)-Tyr-D-Trp-Lys-Val-Cys]-Thr-NH2

H-(D)p-Benzoylphenylalanyl-(D)seryl-(D)tryptophanyl-(D)seryl-(D)pentafluorophenylalanyl-(D)cyclohexylalanyl-(D)arginyl-(D)arginyl-(D)arginyl-(D)glutaminyl-(D)arginyl-(D)arginine acetate salt

For use in combination with cisplatin and pemetrexed for the treatment of patients with mesothelioma

CanBas Company, Ltd.

H-Tyr-Gly-Arg-Lys-Lys-Arg-Arg-Gln-Arg-Arg-Arg-alys-aleu-Ser-Ser-Ile-Glu-Ser-Asp-Val-OH

Treatment of subarachnoid hemorrhage

H-Tyr-Gly-Arg-Lys-Lys-Arg-Arg-Gln-Arg-Arg-Arg-Lys-Leu-Ser-Ser-Ile-Glu- Ser-Asp-Val-OH

Treatment of acute ischemic stroke patients presenting within 3 hours of symptom onset

Collgard Biopharmaceuticals Ltd.


Halo Theraeputics, LLC

HanAll BioPharma Co., Ltd.


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n/a 11/13/20121244

n/a 4/19/20161245

Cadi Mw 11/21/2002 CPL, Inc.1246

Cadi Mw 9/3/2004 Active tuberculosis1247

Cadi-Mw 7/31/20121248


Heat Shock Protein 70 n/a 3/18/2011 ALS Biopharma, LLC1250

n/a 8/27/2014

Hantaan virus and Puumala virus DNA vaccines

Prevention of hemorrhagic fever with renal syndrome caused by Hantaan virus and Puumala virus.

Surgeon General of the U. S. Army

HDF-LV-RTS-MMP1 (human dermal fibroblasts genetically modified with LV-RTS-MMP1) and Veledimex

Treatment of localized scleroderma.

Fibrocell Technologies, Inc.

heat killed mycobacterium w immunomodulator

Adjuvant to multi-drug therapy in the management of multibacillary leprosy

heat killed Mycobacterium w immunomodulator

Cadila Pharmaceuticals Limited, Inc.

heat killed mycobacterium w immunomodulator

Treatment of non-small cell lung cancers that express desmocollin-3

Cadila Pharmaceuticals Limited

heat killed whole cell mycobacterium obuense

Immodulon Therapeutics Limited


hematopoietic stem and progenitor cells expanded ex-vivo with a low molecular weight aryl hydrocarbon receptor (AHR) antagonist

Hematopoietic support in patients with acute lymphoblastic leukemia (ALL)



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Ladilen 11/9/20161252

Heme arginate Normosang 3/1/1994 Orphan Europe1253

Heme arginate Normosang 3/10/1988 Orphan Europe SARL1254

Hemex 12/20/19931255

n/a 12/18/2007 Treatment of cardiogenic shock Apex Bioscience, Inc.1256

heparan sulfate mimetic n/a 5/29/2014 Treatment of pancreatic cancer1257

n/a 10/24/20111258

Heparin sodium n/a 6/29/2006 Treatment of cystic fibrosis1259

n/a 9/18/2006

hematopoietic stem cells modified with a lentiviral vector containing the CD18 (Integrin Beta 2) gene

Treatment of leukocyte adhesion deficiency Type I

Centro de Investigacion Biomedica en Red (CIBER)


Treatment of symptomatic stage of acute porphyria.

Hemin and zinc mesoporphyrin

Treatment of acute porphyric syndromes.

Bonkovsky, Herbert L. M.D.

Hemoximer (pyridoxalated hemoglobin polyoxyethylene)

Momenta Pharmaceuticals, Inc.

heparin activated recombinant human fibroblast growth factor 1 (FGF1)in combination with a surgically implanted biodegradable device

Treatment of patients with a confirmed traumatic complete spinal cord injury where no motor or sensory function is preserved below the injury(Scale A)

BioArctic Neuroscience AB

Ockham Biotech Limited

Heparin-binding epidermal growth factor-like growth factor

Prevention and treatment of necrotizing enterocolitis (NEC) in preterm infants with birth weight less than 1,500 grams

Trillium Therapeutics, Inc.


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Nabi-Hb 3/8/19951261

Hepabig Gene 5/6/2013 Green Cross Corp.1262

Civacir(Tm) 11/14/20021263

hepcortespenlisimut-L n/a 12/17/2014 Immunitor, Inc.1264

n/a 12/23/2014 Treatment of pancreatic cancer Karcinolys S.A.S.1265

Herpes simplex virus gene n/a 10/16/1992 Genetic Therapy, Inc.1266

n/a 1/13/20121267

n/a 3/9/20121268

hexasodium phytate n/a 12/2/2012 Treatment of calciphylaxis1269

n/a 6/27/2016 Treatment of systemic sclerosis iBio, Inc.1270

HIRMAb-IDS n/a 5/15/2013

Hepatitis B immune globulin intravenous (human)

Prophylaxis against hepatitis B virus reinfection in liver transplant patients.

Biotest Pharmaceuticals Corporation

hepatitis B virus neutralizing human monoclonal antibody

Prevention of hepatitis B recurrence following liver transplantation

Hepatitis C virus immune globulin (human)

Prophylaxis of hepatitis C infection in liver transplant recipients.



herpes simplex type 1 virus containing cellular B-myb gene as tumor-specific promoter

Treatment of primary and metastatic brain tumors.

heterologous human adult liver derived progenitor cells (HHALPC)

Treatment of urea cycle disorders

Promethera Biosciences

heterologous human liver derived progenitor cells

Treatment of Crigler-Najjar syndrome

Promethera Biosciences

Laboratoris Sanifit, S.L.

high molecular weight multimer of E3-Fc, an endostatin C-terminus and IgG1-Fc fusion protein

Treatment of mucopolysaccharidosis Type II (Hunter Syndrome)

ArmaGen Technologies, Inc.


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1271n/a 1/13/2016 Treatment of retinal detachment ONL Therapeutics, Inc

1272n/a 3/11/2013 Treatment of retinal detachment ONL Therapeutics, Inc

1273

Histamine Maxamine 2/1/2000 EpiCept Corporation1274

Histamine Ceplene 12/15/1999 EpiCept Corporation1275

Histrelin n/a 5/3/19911276

n/a 1/21/2016 Treatment of uveal melanoma. Immunocore Ltd1277

Allovectin-7 9/30/1999 Vical Incorporated1278

homoharringtonine n/a 2/8/20021279

n/a 1/12/2009 Gliknik, Inc.1280

n/a 9/1/2011 ISA Therapeutics BV

His-His- Ile-Tyr-Leu-Gly-Ala-Val-Asn-Tyr-Ile-Tyr-NH2

His-His-Ile-Tyr-Leu-Gly-Ala-Val-Asn-Tyr-Ile-Tyr

For use as an adjunct to cytokine therapy in the treatment of malignant melanoma.

Adjunct to cytokine therapy in the treatment of acute myeloid leukemia.

Treatment of acute intermittent porphyria, hereditary coproporphyria, and variegate porphyria.

Anderson, Karl E., M.D.

HLA-A2-selective gp100-specific T cell redirector

HLA-B7/Beta2M DNA Lipid (DMRIE/DOPE) Complex

Treatment of invasive and metastatic melanoma (Stages II, III, and IV).

Treatment for chronic myelogenous leukemia

American BioScience, Inc.

HPV-16 cancer therapeutic trojan peptide vaccine

Treatment of HPV-16 expressing head and neck squamous cell carcinoma.

HPV16 E6/E7 synthetic long peptides vaccine

Treatment of epithelial neoplasias of the vulva positive for human papilloma virus type 16.


of 400



1281

Remitogen 11/28/2001 PDL BioPharma, Inc.1282

n/a 11/9/2015 Bone Therapeutics SA1283

Allob 1/10/2014 Treatment of osteonecrosis Bone Therapeutics SA1284

n/a 9/12/2008 Mesoblast, Inc.1285

n/a 4/4/20051286

n/a 9/27/2004 Treatment of Hodgkin's disease1287

Humax-Cd4 8/13/2004 Treatment of mycosis fungoides1288

n/a 7/29/2008 Treatment of multiple myeloma

Hu1D10, humanized monoclonal antibody

For use in the treatment of 1D10+ B cell non-Hodgkin's lymphoma

human allogeneic bone marrow derived osteoblastic cells

Treatment of osteogenesis imperfecta.

human allogeneic bone marrow derived osteoblastic cells

Human Allogeneic HLA-matched, Umbilical Cord Blood Hematopoietic Progenitor Cells Ex Vivo Expanded on Allogeneic Mesenchymal Precursor Cells

Treatment of insufficient hematopoietic stem cell production in patients with hematologic malignancies who have failed treatment with conventional chemotherapy.

Human alpha 2,6 sialyltransferase adenoviral gene therapy

Treatment of patients with invasive (malignant) brain and central nervous system tumors lacking alpha 2,6 sialyltransferase.

Falk Center for Molecular Therapeutics

Human anti-CD30 monoclonal antibody

Bristol-Myers Squibb, Inc.

human anti-CD4 monoclonal antibody

Emergent Product Development Seattle, LLC

human anti-cellular adhesion molecule-1 monoclonal antibody

BioInvent International AB


of 400



1289

n/a 3/24/2008 Treatment of osteonecrosis1290

human coagulation factor VIII Octanate 12/3/20121291

human coagulation factor XI Hemoleven 11/8/20071292

n/a 11/3/2015 Shire1293

n/a 12/20/20061294

n/a 6/2/20161295

n/a 6/19/2014

Human autologous bone-forming cell derived from bone marrow stem cells

Bone Therapeutics S.A.

Immune tolerance induction in hemophilia A patients with inhibitors

OCTAPHARMA USA, Inc.

Treatment of severe congential Factor XI deficiency.

Laboratoire francais du Fractionnement et des Biot

human cystic fibrosis transmembrane conductance regulator (hCFTR) messenger RNA (mRNA) complexed with branched polyethyleneimine (bPEI)

Treatment of patients with cystic fibrosis.

Human cytomegalovirus immunoglobulin

Prevention of congenital cytomegalovirus (CMV) infection following primary CMV infection in pregnant women


human donor hematopoietic stem and progenitor cells (HSPC) that have been treated ex vivo with TBX-4000

Enhancement of cell engraftment in patients receiving hematopoietic stem cell transplant.

Taiga Biotechnologies, Inc.

human fully IgG1 antibody specific for CD33




of 400



1296human gammaglobulin Oralgam 5/25/2001

1297human gammaglobulin Oralgam 11/14/2003

1298

human gammaglobulin Oralgam 9/16/20021299

Q-Cells 9/11/2013 Q Therapeutics, Inc.1300

human haptoglobin n/a 11/19/2013 Treatment of sickle cell disease1301

Human Hemin n/a 8/6/20131302

n/a 5/11/2011 Treatment of acute liver failure Alfact Innovation SAS1303

human heterologous liver cells n/a 2/14/20111304

n/a 10/16/2013 Treatment of systemic sclerosis MedImmune1305

Human immune globulin Flebogamma(R) 5% Dif 3/29/2006 Instituto Grifols, S.A.

Treatment for juvenile rheumatoid arthritis

Latona Life Sciences, Inc.

Treatment of idiopathic inflammatory myopathies


Treatment of gastrointestinal disturbances (to include constipation, diarrhea, and abdominal pain) associated with regression-onset autism in pediatric patients.


human glial restricted progenitor cells and their progeny


BioProducts Laboratory Limited

Prevention of ischemia reperfusion injury in patients undergoing solid organ transplantation

Borders Technology Management Ltd

human Hepatocarcinoma-Intestine-pancreas/pancreatitis associated protein


Promethera Biosciences S.A./N.V.

human IgG1k monoclonal antibody

Treatment of post-polio syndrome


of 400



1306n/a 1/10/2006 Bristol-Myers Squibb

1307human insulin (rDNA) n/a 4/6/2015 Nutrinia, Ltd.

1308

n/a 2/11/2013 Orban Biotech, LLC1309

n/a 6/6/20131310

n/a 2/18/20111311

human laminin-111 n/a 9/23/2011 Prothelia, Inc.1312


n/a 7/7/2005 IRX Therapeutics, Inc.1314

n/a 7/6/2012 Treatment of ovarian cancer Galileo Research srl1315

n/a 5/29/2014 AbbVie, Inc.

Human immunoglobin anti-CD30 monoclonal antibody

Treatment of CD30+ T-cell lymphoma

Treatment of short bowel syndrome (SBS).

human insulin beta chain peptide with incomplete Freund's adjuvant vaccine

Treatment of Type 1 diabetes patients with residual beta cell function

human interleukin-3 genetically conjugated to diphtheria toxin protein

Treatment of blastic plasmacytoid dendritic cell neoplasm

Stemline Therapeutics, Inc.

human interleukin-3 genetically conjugated to diphtheria toxin protein



Treatment of merosin (laminin-alpha2) deficient congential muscular dystrophy type 1A.

human leukocyte antigen-A2 restricted peptides


human leukocyte-derived cytokine mixture

Neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck

human MHC non-restricted cytotoxic T-cell line

Human Monoclonal Antibody against Epidermal Growth Factor Receptor Linked to Monomethylauristatin F



of 400



1316

n/a 11/2/2004 CuraGen Corporation1317

n/a 10/15/20131318

n/a 11/26/2013 Dyax Corporation1319

Aerumab 11 9/18/2006 Kenta Biotech Limited1320

n/a 1/6/2010 Kenta Biotech Limited1321

n/a 5/18/2016 Pfizer, Inc.1322

n/a 12/16/2013 Omeros Corporation

Human monoclonal antibody against platelet-derived growth factor D

To slow the progression of IgA nephropathy and delay kidney failure in patients affected by the disease.

human monoclonal antibody againt human interleukin 13 (IL-13)


Novartis Pharmaceuticals Corporaton

human monoclonal antibody directed against active plasma kallikrein

Treatment of hereditary angioedema (HAE)

Human monoclonal antibody directed against serotype 011 Pseudomonas aeruginosa

Treatment of hospital acquired pneumonia caused by serotype 011 positive Pseudomonas aeruginosa

human monoclonal antibody directed against serotype O1 Pseudomonas aeruginosa

Treatment of pneumonia caused by serotype O1 positive Pseudomonas aeruginosa

human monoclonal antibody directed against tissue factor pathway inhibitor

Treatment of hemophilia A and hemophilia B patients with or without inhibitors, which includes routine prophylaxis to prevent or reduce the frequency of bleeding in hemophilia A and hemophilia B patients.

Human monoclonal antibody inhibitor of mannan-binding lectin-associated serine protease-2 (MASP-2)

Prevention (inhibition) of complement-mediated thrombotic microangiopathy


of 400



1323

n/a 4/30/2010 Treatment of ovarian cancer Ortho Biotech1324

n/a 2/29/20161325

n/a 4/30/2014 Cambryn Biologics1326

human plasminogen n/a 6/7/2010 Kedrion, S.p.A.1327

Tromplate 6/27/2013 Prophylix Pharma AS1328

Octaplex 2/1/2008 Octapharma USA, Inc.1329

n/a 5/4/20161330

n/a 7/6/2012 FibroGen, Inc.

Human monoclonal antibody targeting CC-chemokine ligand 2 (CNTO 888)

human monoclonal antibody targeting human sclerostin

Treatment of osteogenesis imperfecta.

Mereo Biopharma 3 Limited

Human plasma derived conagulation protein-Factor XI

For the treatment of congenital Factor XI deficiency

Treatment of ligneous conjunctivitis

human platelet antigen-1a immunoglobulin (anti-HPA-1a)

Prevention of fetal and neonatal alloimmune thrombocytopenia

Human prothrombin complex concentrate

Reversal of anticoagulation therapy in patients needing treatment of serious or life threatening bleeding and/or needing urgent surgery or invasive procedures

human recombinant bone morphogenetic protein 4


HyperStem Therapeutics, Inc.

human recombinant DNA-derived, IgG1 kappa monoclonal anti-body to connective growth factor



of 400



1331

n/a 2/4/2016 AbbVie, Inc.1332

n/a 12/22/20141333

human retinal progenitor cells n/a 7/23/2012 jCyte, Inc.1334

n/a 10/14/2015 Treatment of ovarian cancer. Atara Biotherapeutics1335

n/a 2/4/2011 Neuralstem, Inc.1336

Vaxsyn Hiv-1 11/20/1989 Treatment of AIDS. MicroGeneSys, Inc.1337

n/a 7/20/2006 Treatment of pancreatic cancer GemVax A/S

human recombinant dual-variable domain immunoglobulin G1 monoclonal antibody that selectively neutralizes tumor necrosis factor-alpha and interkeukin-17A

Treatment of pediatric patients 0 to

human recombinant mesencephalic, astrocyte derived neurotrophic factor




human soluble receptor-Fc fusion protein that targets human activin A

human spinal cord derived neural stem cells


Human T-lymphotropic virus type III Gp160 antigens

Human telomerase reverse transcriptase peptide vaccine


of 400



1338


n/a 10/1/2009 Treatment of liver cancer1340

Pneumostem 11/26/20131341

n/a 12/23/20151342

n/a 2/23/2016 treatment of mesothelioma.1343

n/a 1/20/20161344

n/a 6/24/2013 Treatment of neuroblastoma

human trtravalent, bi-specific monoclonal antibody that binds and co-inhibits two growth factor receptors; insulin-like growth factor receptor 1 (IGF-1R) and v-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3 (ErbB3)


human tumor necrosis factor coupled to the C terminus of CNGRCG peptide

Molecular Medicine S.p.A. (Molmed)

human umbilical cord blood-derived mesenchymal stem cells

Prevention of bronchopulmonary dysplasia

MEDIPOST America, Inc.

Human Wilms tumor protein 1 peptides


SELLAS Life Sciences Group

Human wilms tumor protein 1 peptides

SELLAS Life Sciences Group

Human/Murine Chimeric Monoclonal antibody to Endoglin


Tracon Pharmaceuticals, Inc.

Humanized 3F8-IgG1 monoclonal antibody

Memorial Sloan-Kettering Cancer Center


of 400



1345

n/a 2/10/2016 MedImmune, LLC1346

n/a 9/29/2006 MacroGenics, Inc.1347

n/a 6/30/20141348

Humanized anti-tac Zenapax 3/5/19931349

n/a 4/29/2014 MorphoSys AG1350

n/a 12/1/2014 MorphoSys AG1351

n/a 2/17/20121352

n/a 5/26/2011 MENTRIK Biotech, LLC1353

humanized IgG2 antibody n/a 7/22/2008

humanized affinity-optimized, afucosylated immunoglobulin G1 kappa monoclonal antibody against CD19

Treatment of neuromyelitis optica and neuromyelitis optica spectrum disorders

Humanized anti-CD3 monoclonal antibody

Treatment of recent-onset Type I diabetes

humanized anti-IL-6R receptor neutralizing IgG2 monoclonal antibody


Chugai Pharma USA, LLC

Prevention of acute graft-vs-host disease following bone marrow transplantation.


humanized Fc engineered monoclonal antibody against CD19

Treatment of patients with chronic lymphocytic leukemia/small lymphocytic lymphoma

humanized Fc engineered monoclonal antibody against CD19


humanized IgG1 anti-serum amyloid A monoclonal antibody

Treatment of AA amyloidosis and AL amyloidosis

Prothena Therapeutics Limited

humanized IgG1 monoclonal anti-CD20 antibody


Treatment of vaso-occlusive crisis in patients with sickle cell disease.

Selexys Pharmaceuticals Corp.


of 400



1354

n/a 12/12/2011 Opsona Theraeputics1355

n/a 7/27/20161356

n/a 8/16/2016 Vaccinex, Inc.1357

n/a 8/30/20161358


n/a 9/11/20141360

n/a 8/5/2010 Biogen Idec, Inc.1361

n/a 8/20/2015 Forty Seven, Inc.

humanized IgG4 monoclonal antibody

Prevention of ischemia/reperfusion injury associated with solid organ tranplantation

humanized IgG4 monoclonal antibody against total complement component 1, subcomponent s (C1s)

Treatment of autoimmune hemolytic anemia (AIHA)

True North Therapeutics, Inc.

humanized IgG4 monoclonal antibody that binds to the SEMA4D antigen


humanized IgG4 monoclonal antibody to Toll-Like Receptor 2 (TLR2)


Opsona Therapeutics Ltd.

humanized immunoglobulin monoclonal antibody against CD38

Sanofi U.S. Services, Inc.

humanized monoclonal antibodies hu1B7 and hu11E6

Treatment of Bordetella pertussis

Synthetic Biologics, Inc.

humanized monoclonal antibody against human integrin alphaVbeta6


humanized monoclonal antibody of the IgG4 kappa isotype targeting CD47

Treatment of acute myeloid (myelogenous) leukemia.


of 400



1362

n/a 5/5/20151363

n/a 4/26/2011 Treatment of pancreatic cancer. Morphotek, Inc.1364

n/a 4/29/2011 Treatment of soft tissue sarcoma Morphotek1365

n/a 6/18/2008 Stromedix, Inc.1366

n/a 11/17/20111367

n/a 12/3/2009 Treatment of scleroderma MedImmune1368

hyaluronic acid n/a 3/19/2002 CoTherix

humanized monoclonal antibody that targets the a-subunit of the human IL-3 receptor also known as the CD123 antigen; (JNJ-56022473)



humanized monoclonal antibody to tissue factor

Humanized monoclonal antibody to TumorEndothelial Marker-1

humanized monocloncal antibody against human integrin alphaVbeta6

Treatment of fibrosis-associated chronic allograft nephropathy in kidney transplant patients.

humanized single chain monoclonal antibody(scFV: IgG1 hinge: IgG1 CH2 and CH3 domains)


Emergent Product Development Seattle, LLC

humanized, afucosylated IgG1 kappa monoclonal antibody

Treatment of emphysema in patients due to alpha-1 antitrypsin deficiency


of 400



1369

Hydralazine n/a 4/9/20041370

Transkrip(R) 3/17/20111371

Transkrip(R) 3/17/20111372

n/a 3/9/2015 Alsonex Pty Ltd1373

Chronocort(R) 9/3/2015 Diurnal Ltd.1374

Chronocort 3/18/2015 Diurnal Limited1375

Duocort 6/18/20081376

hydrocortisone oral granules Infacort(R) 5/13/2015 Diurnal Limited1377

n/a 6/16/2016 Mallinckrodt Inc.1378

Hydroxocobalamin n/a 9/22/2000 Jazz Pharmaceuticals1379

Trappsol 5/17/2010 Sphingo Biotech, LLC

Treatment of severe intrapartum hypertension (diastolic blood pressure greater than or equal to 110 or systolic blood pressure greater than or equal to 160) associated with severe preeclampsia/eclampsia of pregnancy

Bioniche Pharma USA LLC

hydralazine - magnesium valproate


Neolpharma S.A.DE C.V.

hydralazine - magnesium valproate

Treatment of cutaneous T-cell lymphoma.

Neolpharma S.A.DE C.V.

hydrocinnamate-[Orn-Pro-dCha-Trp-Arg](CH3COO)


hydrocortisone modified release capsules

Treatment of adrenal insufficiency.

hydrocortisone modified release capsules

Treatment of congenital adrenal hyperpasia

hydrocortisone modified release tabs

Treatment of adrenal insufficiency


Treatment of pediatric adrenal insufficiency (0 through 16 years of age).

hydromorphone hydrochloride (intrathecal infusion)

Treatment of complex regional pain syndrome

Treatment of acute cyanide poisoning

Hydroxy-Propyl-Beta-Cyclodextrin

Treatment of Niemann Pick Disease, Type C


of 400



1380

Siklos 7/24/20131381

hydroxyurea Pedroxa 3/16/20151382

hydroxyurea n/a 4/15/20051383

Hypericin n/a 2/7/2000 Soligenix, Inc.1384

Hypericin n/a 8/3/2000 HyBiopharma, Inc.1385

Meveol 11/5/2009 Treatment of cystic fibrosis1386

I(131)-TM-601 (chlorotoxin) n/a 2/14/2002 Treatment of malignant glioma Morphotek, Inc.1387

ibalizumab n/a 10/20/2014 TaiMed Biologics, Inc.1388

ibrutinib n/a 9/8/2014 Pharmacyclics, LLC

hydroxycarbamide (hydroxyurea)

Treatment of sickle cell disease in patients under 18 years of age

addmedica Laboratories

Treatment of symptomatic sickle cell disease in pediatric patients, less than 17 years of age.

Ebelle D'Ebelle Pharmaceuticals LLC

Treatment of pediatric patients with sickle cell anemia.

UPM Pharmaceuticals, Inc.



Hypothiocyanite and lactoferrin

Alaxia Biotechnologies Sante

Treatment of HIV-1 infection in treatment experienced adult patients with documented multi-antiretroviral class resistance and evidence of HIV-1 replication despite ongoing antiretroviral therapy



of 400



1389

ibrutinib Imbruvica 2/2/2016 Pharmacyclics, LLC1390

ibrutinib n/a 6/23/2016 Pharmacyclics, LLC1391

ibrutinib n/a 5/16/2013 Treatment of multiple myeloma Pharmacyclics, LLC1392



ibrutinib n/a 10/23/2013 Pharmacyclics, LLC1395 ibudilast n/a 6/1/2015 Treatment of Krabbe disease MediciNova, Inc.1396

ibudilast n/a 10/6/2016 MediciNova, Inc.1397

Ibuprofen i.v. solution Salprofen 10/29/1996 Farmacon-IL, LLC1398

idebenone n/a 3/25/2004 Treatment of Friedreich's ataxia1399

idebenone n/a 2/16/20071400

idebenone n/a 5/22/2009

Treatment of patients with extranodal marginal zone lymphoma (mucosa associated lymphoid tissue [MALT type] lymphoma)

Treatment of chronic Graft versus Host disease.

Treatment of nodal marginal zone lymphoma

Treatment of splenic marginal zone lymphoma



Prevention of patent ductus arteriosus.

Santhera Pharmaceuticals LLC


Santhera Pharaceuticals Limited

Treatment of mitochondrial myopathy, encephalopathy, lactic acidosis with stroke-like episodes syndrome (MELAS)

Santhera Pharmaceuticals Limited


of 400



1401

idebenone n/a 10/31/20061402

idelalisib n/a 9/26/2013 Gilead Sciences, Inc.1403





Idoxuridine n/a 4/8/1996 NeoPharm, Inc.1408

IDUA-HIRMAb fusion protein n/a 1/10/20081409

idursulfase beta n/a 2/11/2013 Green Cross Corp.1410

idursulfase IT n/a 9/3/2009

Treatment of Leber's hereditary optic neuropathy.


Treatment of lymphoplasmacytic lymphoma with or without Walenstrom's macroglobulinemia

Treatment of splenic marginal zone lymphoma

Treatment of extranodal marginal zone lymphoma

Treatment of nodal marginal zone lymphoma.


Treatment of nonparenchymatous sarcomas.

Treatment of mucopolysaccharidosis Type 1 (MPS)

ArmaGen Technologies, Inc.

Treatment of Hunter Syndrome (mucopolysaccharidoses)

For treatment of neurocognitive symptoms associated with Hunter Syndrome

Shire Human Genetic Therapies


of 400



1411

iduvec n/a 1/21/2011 Zebraic Corporation1412

iferanserin (S-MPEC) n/a 12/13/20101413

ifosfamide n/a 8/7/19851414


n/a 6/24/2013 Treatment of malignant glioma1416

n/a 4/6/2000 Treatment of astrocytic glioma.1417

iloprost n/a 4/6/20121418

imatinib mesylate n/a 5/6/20141419

Imciromab pentetate Myoscint 1/25/1989 Centocor, Inc.1420

imetelstat n/a 12/23/20151421

imetelstat n/a 6/11/2015 Treatment of myelofibrosis

Treatment of Mucopolysaccharidosis Type I

For use in pulmonary arterial hypertension.

Sam Amer & Company, Inc.

Treatment of soft tissue and bone sarcomas


IgG1 chimeric monoclonal antibody

Immune System Therapeutics Ltd

IL-12 secreting dendritic cells loaded with autologous tumor lysate

Activartis Biotech GmbH

IL-4 Pseudomonas Toxin Fusion Protein (IL-4(38-37)-PE38KDEL)

Medicenna Therapeutics, Inc.


Algorithum Sciences, LLC

Treatment of progressive multifocal leukencephalopathy

Inhibikase Therapeutics, Inc.

Detecting early necrosis as an indication of rejection of orthotopic cardiac transplants.





of 400



1422Imexon n/a 11/8/1996 Treatment of multiple myeloma.

1423imexon Amplimexon 8/12/2005 Treatment of ovarian cancer.

1424

Imiquimod n/a 12/3/2014 UroGen Pharma Ltd1425

Elad 7/16/2004 Vital Therapies, Inc.1426

immune globulin (human) n/a 3/2/2010 Octapharma USA, Inc.1427

3/17/20041428

n/a 3/31/2016 Baxalta US, Inc.1429

Carimune Nf 5/4/2004 ZLB Bioplasma AG1430

Hizentra 8/18/2014 CSL Behring1431

n/a 9/10/2015 Hansa Medical AB1432

n/a 6/1/2015 Treatment of Hemophilia A

AmpliMed Corporation

AmpliMed Corporation

Treatment of carcinoma in situ (CIS) of the urinary bladder

Immortalized human liver cells found in the extracorporeal liver assist device

Treatment of fulminant hepatic failure (acute liver failure)

Treatment of Guillain-Barre syndrome

Immune Globulin (Human) containing high titers of West Nile virus antibodies

Omr-Igg-Am (Tm) 5% (Wnv)

Treatment of the West Nile virus infection

OMRIX Biopharmaceuticals, Ltd.

immune globulin infusion 10% (human) with recombinant human hyaluronidase)


Immune Globulin Intravenous (human)

Treatment for Guillain Barre Syndrome

Immune Globulin Subcutaneous (Human), 20% Liquid

Treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)

immunoglobulin G degrading enzyme of Streptococcus pyogenes

Prevention of antibody mediated organ rejection in solid organ transplant patients.

immunologically active synthetic peptides

Apitope International NV


of 400



1433

n/a 3/16/1994 Cytel Corporation1434

n/a 5/12/1992 ALK Laboratories, Inc.1435

Inalimarev and falimarev n/a 1/10/20061436

n/a 9/4/2014 Biostage, Inc.1437

Indium-111 pentetreotide Neuroendomedix 6/16/20061438

Inecalcitol n/a 5/14/2014 Hybrigenics, S.A.1439

inecalcitol n/a 8/3/2015 Hybrigenics, S.A.

Immunotherapeutic vaccine consisting of (PAM)2-Lys-Ser-Ser-Gln-Tyr-Ile-Lys-Ala-Asn-Ser-Lys-Phe-Ile-Gly-Ile-Thr-Glu-Ala-Ala-Ala-Phe-Leu-Pro-Ser-Asp-Phe-Phe-Pro-Ser-Val

Treatment of chronic active hepatitis B infection in HLA-A2 positive patients.

Imported fire ant venom, allergenic extract

For skin testing of victims of fire ant stings to confirm fire ant sensitivity and if positive, for use as immunotherapy for the prevention of IgE-mediated anaphylactic reactions.

Treatment of adenocarcinoma of the pancreas

Therion Biologics Corporation

inBreath airway transplant system

To restore the structure and/or function of the trachea subsequent to tracheal damage due to cancer, injury or infection


RadioIsotope Therapy of America (RITA) Foundation




of 400



1440infliximab Remicade 10/23/2002 Centocor, Inc.

1441Infliximab Remicade 5/21/2003 Treatment of chronic sarcoidosis Centocor, Inc.

1442

n/a 10/2/20141443

n/a 1/29/20101444

inolimomab Leukotac 10/23/2002 Jazz Pharmaceuticals1445

Inosine pranobex Isoprinosine 9/20/19881446

inotuzumab ozogamicin n/a 3/25/2013 Pfizer, Inc.1447

n/a 9/5/20081448

Roferon-A 10/27/19891449

Roferon-A 5/11/1990

Treatment of juvenile rheumatoid arthritis

Inhibitor of primary and secondary KIT and PDGFR alpha kinase mutants found in GIST

Treatment of gastrointestinal stromal tumors (GIST)


Inhibitor of Tissue Factor Pathway Inhibitor (TFPI)

Treatment of hemophilia A and hemophilia B.

Baxter Healthcare Corporation, Baxter BioScience


Treatment of subacute sclerosing panencephalitis.

Newport Pharmaceuticals

Treatment of B-cell acute lymphoblastic leukemia

insecticidal toxin derived from Bacillus thuringiensis

Treatment of soil transmitted helminth infection strongyloidiasis

University of California, San Diego

Interferon alfa-2a (recombinant)

For use in combination with fluorouracil for the treatment of esophageal carcinoma.



For the treatment of metastatic malignant melanoma in combination with Teceleukin.



of 400



1450

Roferon-A 5/14/19901451

Roferon-A 4/18/19881452

Roferon-A 5/2/19901453

Interferon beta-1a Rebif 3/11/1996 EMD Serono, Inc.1454

n/a 7/24/1992 Biogen, Inc.1455

Rebif 12/2/1992 EMD Serono, Inc.1456

Interferon gamma n/a 10/11/20071457

interferon gamma n/a 11/4/2011 Treatment of Friedreich's ataxia Roberto Testi, MD1458

interferon gamma-1b Actimmune 10/1/2014 Treatment of Friedreich's Ataxia1459

Interferon gamma-1b Actimmune 12/4/1995


For the concomitant administration with fluorouracil for the treatment of advanced colorectal cancer.






For the concomitant administration with Teceleukin for the treatment of metastatic renal cell carcinoma.


Treatment of patients with secondary progressive multiple sclerosis.

Interferon beta-1a (recombinant human)

Treatment of acute non-A, non-B hepatitis.

Interferon beta-1a (recombinant)

Treatment of symptomatic patients with AIDS including all patients with CD4 T-cell counts less than 200 cells per mm3.


mondoBIOTECH Laboratories AG

Horizon Pharma Ireland Limited




of 400



1460Interferon-alfa-1b n/a 4/17/2001 Treatment of multiple myeloma Ernest C.Borden

1461

Infradure Biopump 6/14/2012 Treatment of chronic hepatitis D Medgenics, Inc.1462

Kineret 9/15/20151463

Antril 9/23/19911464

Antril 10/16/19921465

Interleukin-1 Trap n/a 4/4/20051466

Interleukin-2 Teceleukin 5/3/19901467



interferon-alpha secreting autologous micro-organ tissue converting into a biopump

interleukin-1 receptor antagonist anakinra

Treatment of Still's disease including systemic juvenile idiopathic arithritis and adult-onset Still's disease.

Swedish Orphan Biovitrum AB

Interleukin-1 receptor antagonist, human recombinant


Swedish Orphan Biovitrum AB (publ) (SOBI)

Interleukin-1 receptor antagonist, human recombinant

Prevention and treatment of graft versus host disease in transplant recipients.


Treatment of Still's disease including juvenile rheumatoid arthritis and adult-onset Still's disease


In combination with interferon alfa-2a for the treatment of metastatic renal cell carcinoma.


In combination with interferon alfa-2a for the treatment of metastatic malignant melanoma.


Treatment of metastatic renal cell carcinoma.



of 400



1469Interleukin-2 Teleleukin 2/6/1990

1470

Ifrs 7/31/2001 Digestive Care, Inc.1471

Intravenous immune globulin Vitigam 7/26/2007 GammaCan Ltd.1472

Octagam(R) 7/31/2008 Octapharma USA, Inc.1473

intraventricular nimodipine n/a 5/28/20151474

Iobenguane I 131 Azedra Ultratrace 1/18/20061475

iobenguane I 131 n/a 7/5/20071476

Iobenguane Sulfate I-123 Omaclear 10/17/20051477

iobenguane sulfate I-123 Omaclear 10/21/20051478

n/a 8/1/1984 David E. Kuhl, M.D.1479

n/a 11/7/1988 Immunomedics, Inc.

Treatment of metastatic malignant melanoma.


Intraoral fluoride releasing system

Prevention of dental caries due to radiation-induced xerostomia in patients with head and neck cancer

Treatment of Stage IIB to IV malignant melanoma

Intravenous immune globulin (human) 10%

Treatment of stiff-person syndrome


Edge Therapeutics, Inc.


Molecular Insight Pharmaceuticals


Jubilant DraxImage, Inc.

For scintigraphic detection, localization and staging of neuroblastoma.

Brogan Pharmaceuticals, LLC

For the detection, localization, and staging of pheochromocytomas.

Brogan Pharmaceuticals, Inc.

Iodine 131 6B-iodomethyl-19-norcholesterol

For use in adrenal cortical imaging.

Iodine I 123 murine monoclonal antibody to hCG

Detection of hCG producing tumors such as germ cell and trophoblastic cell tumors.


of 400



1480

Pentacea 2/22/20001481

131ichtnt-1 2/12/19991482

isavuconazonium sulfate n/a 10/20/20141483

Isobutyramide 12/18/19921484

Isobutyramide n/a 5/25/19941485

n/a 6/9/20151486


isofagomine tartrate n/a 1/10/2006 Treatment of Gaucher disease1488

Isoindolin-1,3-Di Thione n/a 11/21/2016 P2D, Inc.

Iodine I 131 bis(indium-diethylenetriaminepentaacetic acid)tyrosyllysine/hMN-14 x m734 F(ab')2 bispecific monoclonal antibody

Treatment of small-cell lung cancer.

IBC Pharmaceuticals, L.L.C.

Iodine I-131 radiolabeled chimeric MAb tumor necrosis treatment (TNT-1B)

Treatment of glioblastoma multiforme and anaplastic astrocytoma.

Peregrine Pharmaceuticals, Inc.

Treatment of invasive candidiasis/candidemia


Isobutyramide Oral Solution

Treatment of beta-hemoglobinopathies and beta-thalassemia syndromes.

Perrine, Susan P., M.D.

Treatment of sickle cell disease and beta thalassemia.


isocitrate dehydrogenase 1 (IDH1)-mutant inhibitor


Agios Pharmaceuticals, Inc.

isocitrate dehydrogenase 2-mutant inhibitor


Amicus Therapeutics, Inc.

Treatment of Frontotemporal dementia


of 400



1489

isotretinoin n/a 4/10/20141490

Itraconazole n/a 5/19/20161491

n/a 8/16/2016 Pulmatrix, Inc1492

Itraconazole suspension n/a 10/30/20081493

ivabradine n/a 3/23/2016 Amgen, Inc.,1494

n/a 5/19/1999 Glovax Co., Ltd.1495

ketotifen n/a 2/25/2015 Treatment of mastocytosis1496

Kre-Celazine n/a 4/1/20131497

Procysteine 7/30/19961498

Procysteine 6/14/1994

Treatment of congenital ichthyosis

Patagonia Pharmaceuticals, LLC

Treatment of basal cell carcinoma nevus syndrome.

HedgePath Pharmaceuticals, Inc

itraconazole inhalation powder

Treatment of pulmonary fungal infections in patients with cystic fibrosis

Topical treatment of fungal otitis externa (otomycosis)

Fairfield Clinical Trials, LLC

Treatment of pediatric patients (0 through 16 years of age) with dilated cardiomyopathy.

Japanese encephalitis vaccine (live, attenuated)

Prevention of Japanese encephalitis.

Valcrest Pharmaceuticals, LLC

Treatment of juvenile rheumatoid arthritis joint and related tissue inflammation in the pediatric population

All American Pharmaceutical & Natural Foods Corpor

L-2-oxothiazolidine-4-carboxylic acid


Transcend Therapeutics, Inc.

L-2-oxothiazolidine-4-carboxylic acid

Treatment of adult respiratory distress syndrome.

Transcend Therapeutics, Inc.


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1499L-5 Hydroxytrytophan n/a 11/1/1984

1500

L-5-hydroxytryptophan n/a 1/20/19991501

n/a 1/12/20111502

n/a 1/18/2006 CepTor Corporation1503

n/a 9/11/2013 Soligenix, Inc.1504

L-asparaginase n/a 3/27/2014 ERYTECH Pharma S.A.1505

Graspa 1/6/2010 Erytech Pharma1506

Graspa 7/6/2012 Treatment of pancreatic cancer. ERYTECH Pharma1507

L-baclofen Neuralgon 1/30/19921508

L-baclofen n/a 12/17/19911509

L-baclofen n/a 7/13/1990 Fromm, Gerhard M.D.

Treatment of postanoxic intention myoclonus.


Treatment of tetrahydrobiopterin deficiency.


L-amino acids, vitamins and minerals combined with omega-3 fatty acids

Treatment of patients with pediatric Crohn's disease

Immunopath Profile, Inc.

L-aminocarnityl-succinyl-leucyl-argininal-diethylacetal

Treatment of Duchenne and Becker muscular dystrophy

L-arginyl-L-isoleucyl-L-valyl-L-prolyl-L-alanine-amide

Treatment of acute radiation syndrome


L-asparaginase encapsulated in red blood cells


L-asparaginase encapsulated in red blood cells

Treatment of intractable spasticity in children with cerebral palsy.

Osmotica Pharmaceutical Corp.

Treatment of spasticity associated with spinal cord injury or multiple sclerosis.


Treatment of trigeminal neuralgia.


of 400



1510

L-baclofen n/a 1/6/19981511

L-cycloserine n/a 8/1/1989 Treatment of Gaucher's disease. Lev, Meir M.D.1512

L-cysteine n/a 5/16/19941513

L-glutamine n/a 8/1/2001 Treatment of sickle cell disease Emmaus Medical, Inc.1514

L-glutamyl-L-tryptophan n/a 10/20/19991515

L-ornithine phenylacetate n/a 4/7/20101516

n/a 9/13/20111517

n/a 9/18/20091518

n/a 6/13/2016



For the prevention and lessening of photosensitivity in erythropoietic protoporphyria.

Brigham and Women's Hospital

Treatment of AIDS-related Kaposi's sarcoma.

Implicit Bioscience Pty Ltd

Treatment of hyperammonemia and resultant hepatic encephalopathy (HE) in patients with acute liver failure or acute on chronic liver disase

Ocera Therapeutics, Inc.

L-pyr-L-glu-L-gln-L-leu-L-glu-L-arg-L-ala-L-leu-L-asn-L-ser-L-ser

Treatment of neuropathic pain in patients with sarcoidosis.

Araim Pharmaceuticals, Inc.


Prevention of delayed graft function following renal transplant



Treatment to increase survival and improve functioning of pancreatic islets following transplantation



of 400



1519

n/a 6/13/2016 Treatment of sarcoidosis.1520

n/a 4/26/20051521

L-tyrosine-L-serine-L-leucine Cms-024 9/10/20041522

L. reuteri n/a 8/1/20131523

Lactic acid Aphthaid 6/29/19991524

n/a 1/15/20021525

n/a 1/15/20021526

n/a 3/24/2015



L-threonyl-L-prolyl-L-prolyl-L-threonine

Treatment of neuropathic pain associated with spinal cord injury

Nyxis Neurotherapies, Inc.


CMS Peptides Patent Holding Company Limited

Prevention of necrotizing enterocolitis in preterm infants with birth weight less than or equal to 1,500 grams

Infant Bacterial Therapeutics

Treatment of severe aphthous stomatitis in severely, terminally immunocompromised patients.

Frontier Pharmaceutical, Inc.

lactic acid bacteria (Lactobacilli, Bifidobacteria, and Steptococci)

Treatment of active chronic pouchitis

VSL Pharmaceuticals, Inc.

lactic acid bacteria (Lactobacilli, Bifidobacteria, and Streptococcus species)

Prevention of disease relapse in patients with chronic pouchitis


Lactobacillus acidophilus and Bifidobacterium animalis subsp. lactis

Prevention of necrotizing enterocolitis (NEC) in premature infants with very low birth weight less than or equal to 1500 grams



of 400



1527

lactobacillus brevis CD2 n/a 10/4/2011 Treatment Behcet's disease1528

lactobacillus plantarum n/a 11/30/2016 New Biotic, LLC1529

laminin-111 (human) n/a 7/21/2011 Prothelia, Inc.1530

lanreotide acetate n/a 9/8/20111531

Laromustine Cloretazine 3/27/20141532

laromustine Onrigin 10/21/20041533

Latrodectus immune F(ab)2 Analatro 6/18/20011534

lebrikizumab n/a 3/9/2015 Genentech, Inc.1535

ledipasvir/sofosbuvir Harvoni 10/12/2016 Gilead Sciences, Inc.1536

Leflunomide n/a 10/18/19961537

lenalidomide Revlimid 4/29/2015 Celgene Corporation




Treatment of symptoms associated with carcinoid syndrome

Ipsen Biopharmaceuticals, Inc.


Nanotherapeutics, Inc.


Vion Pharmaceuticals, Inc.

Treatment of black widow spider envenomations

Instituto Bioclon, S.A. de C.V.


Treatment of chronic hepatitis C virus (HCV) infection in pediatric patients

Prevention of acute and chronic rejection in patients who have received solid organ transplants.

Williams, MD, James W.

Treatment of extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue


of 400



1538lenalidomide Revlimid 1/17/2007 Celgene Corporation



1541Stargen (Tm) 4/30/2010 Treatment of Stargardt disease

1542

n/a 3/23/20161543

Ushstat(Tm) 5/17/20101544

Thalagen 1/11/20061545

lenvatinib n/a 3/27/2014 Eisai, Inc.1546

lenvatinib n/a 3/26/2014 Eisai, Inc.1547

lestaurtinib n/a 9/3/20091548

Lestaurtinib n/a 3/24/2006




Lentiviral vector containing the human ABCA4 gene


lentiviral vector containing the human liver and erythroid pyruvate kinase gene

Treatment of pyruvate kinase deficiency.

Centro de Investigacion Biomedica en RED (CIBER)

Lentiviral vector containing the human MY07A gene

Treatment of retinitis pigmentosa associated with Usher syndrome 1B gene defect.


Lentiviral vector encoded with a human beta-globin gene plasmid

Treatment of beta-thalassemia major and beta-thalassemia intermedia



Treatment of stage IIB to Stage IV melanoma

Treatment of Philadelphia-negative classic myeloproliferative disorders





of 400



1549

letermovir n/a 12/12/20111550

leukocyte interleukin Multikine 5/4/2007 CEL-SCI Corporation1551

n/a 1/26/2015 Treatment of cystic fibrosis Celtaxsys, Inc.1552

Leupeptin n/a 9/18/19901553

levetiracetam Keppra 4/30/2010 Treatment of neonatal seizures1554

levocarnitine Carnitor 11/15/19891555

Levocarnitine Carnitor 4/7/19971556


Prevention of human cytomegalovirus viremia and disease in at risk populations

Merck Sharpe & Dhome Corporation

Neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck

leukotriene A4 hydrolase inhibitor

For use as an adjunct to microsurgical peripheral nerve repair.

Neuromuscular Adjuncts, Inc.

University of California

1. Prevention of secondary carnitine deficiency in valproic acid toxicity 2. Treatment of secondary carnitine deficiency in valproic acid toxicity


Treatment of zidovudine-induced mitochondrial myopathy.


Treatment of pediatric cardiomyopathy.



of 400



1557

Levofloxacin n/a 2/27/2008 Horizon Orphan LLC1558

levomefolate calcium n/a 2/10/2015 Cox Biosciences LLC1559

levothyroxine sodium n/a 4/26/20111560

liposomal amikacin Arikace 3/9/2006 Insmed, Inc.1561

liposomal amikacin Arikace 3/25/2013 Insmed, Inc.1562

liposomal amikacin Arikace 8/25/2009 Insmed, Inc.1563 Liposomal amphotericin B Ambisome 12/10/1996 Treatment of histoplasmosis. Fujisawa USA, Inc.1564

Liposomal annamycin n/a 6/17/2005

Treatment of pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis patients

Treatment of megaloblastic anemia caused by folate deficiency

The preservation of organ function in brain-dead organ donors.

Fera Pharmaceuticals, LLC

Treatment of bronchopulmonary Pseudomonas aeruginosa infections in cystic fibrosis patients

Treatment infections caused by non-tuberculous mycobacteria

Treatment of bronchiectasis in patients with Pseudomonas aeruginosa or other susceptible microbial pathogens




of 400



1565

Liposomal annamycin n/a 6/17/20051566

liposomal busulfan Busulipo 6/24/2013 Pharmalink AB1567

n/a 12/27/2006 Management of bronchiectasis Aradigm Corporation1568

n/a 4/19/2006 Management of cystic fibrosis Aradigm Corporation1569

n/a 6/1/2012 Aradigm Corporation1570

Liposomal cisplatin Lipova-Pt 5/23/2006 Treatment of ovarian cancer1571

Liposomal cyclosporin A Cyclospire 4/30/1998 Vernon Knight, M.D.1572

liposomal cyclosporine n/a 5/11/2009 PARI Pharma GmbH1573

n/a 6/24/2008 PARI Pharma GmbH1574

Sarcodoxome 12/27/2006 GP-Pharm SA



For use as a conditioning regimen for patients with malignancies undergoing autologous or allogenic hematopoietic stem cell transplantation

Liposomal ciprofloxacin for inhalation

Liposomal ciprofloxacin for inhalation

liposomal ciprofloxacin plus ciprofloxacin

For the management of cystic fibrosis


For aerosolized administration in the prevention and treatment of lung allograft rejection and pulmonary rejection events associated with bone marrow transplantation.

Treatment of bronchiolitis obliterans

liposomal cyclosporine for inhalation

Prevention of bronchiolitis obliterans.

Liposomal doxorubicin hydrochloride



of 400



1575n/a 1/21/2015 Treatment of ovarian cancer

1576liposomal gadodiamide n/a 11/12/2008 Treatment of glioma.

1577liposomal glutathione n/a 5/18/2016

1578

Liposomal Glutathione n/a 4/30/20101579

Immther 6/10/1998 Treatment of osteosarcoma. Endorex Corp.1580

Immther 6/10/1998 Treatment of Ewing's sarcoma. Endorex Corp.1581

Liposomal nystatin Nyotran 6/13/20001582

n/a 4/27/20151583

n/a 12/5/2003 Bio-Path, Inc.1584

n/a 10/30/2008 Treatment of gliomas

liposomal encapsulated paclitaxel


MedGenesis Therapeutix, Inc.

Treatment of Dengue Virus infection.

Your Energy Systems, LLC

Support of glutathione deficiency in individuals with inborn errors of metabolism of glutathione (IEMG)

Your Energy Systems, LLC

Liposomal N-Acetylglucosminyl-N-Acetylmuramly-L-Ala-D-isoGln-L-Ala -gylcerolidpalmitoyl

Liposomal N-Acetylglucosminyl-N-Acetylmuramly-L-Ala-D-isoGln-L-Ala -gylcerolidpalmitoyl

Treatment of invasive fungal infections.

The University of Texas

liposomal P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide


Bio-Path Holdings, Inc.

liposomal p-ethoxy growth receptor bound protein-2 antisense product


liposomal topotecan hydrochloride

MedGenesis Therapeutix, Inc.


of 400



1585liposomal vinorelbine n/a 10/12/2016

15869/28/2012

1587n/a 12/3/2014 Treatment of gastric cancer

1588n/a 6/20/1994

1589n/a 11/25/1991

1590

Lisofylline n/a 6/10/1999 Cell Therapeutics, Inc.1591

listeria monocytogenes n/a 9/5/2013 Treatment of pancreatic cancer Aduro BioTech, Inc.1592

lisuride n/a 1/17/2013 Sinoxa Pharma GmbH1593

n/a 12/13/2010 Medesis Pharma1594

n/a 11/4/2013 Advaxis, Inc.1595

n/a 5/21/2014 Treatment of osteosarcoma. Advaxis, Inc.

Treatment of cutaneous t-cell lymphoma (CTCL)

Taiwan Liposome Company, Ltd.

liposomal Ã}Â±-galactosylceramide

Lip. Alpha Galactosylceramide

Prevention of graft-versus-host disease

REGiMMUNE Corporation

liposome encapsulated paclitaxel


Liposome encapsulated recombinant interleukin-2

Treatment of cancers of the kidney and renal pelvis

Oncothyreon Canada, Inc.

Liposome encapsulated recombinant interleukin-2

Treatment of brain and CNS tumors.

Oncothyreon Canada, Inc.

Treatment of patients undergoing induction therapy for acute myeloid leukemia.


lithium citrate tetrahydrate (in reverse micelle formulation)


live attenuated bioengineered Listeria monocytogenes immunotherapy

Treatment of human papilloma virus-associated head and neck cancer

live attenuated bioengineered Listeria monocytogenes immunotherapy


of 400



1596

n/a 12/20/2010 Marina Biotech1597

n/a 8/22/2016 Synlogic, Inc.1598

Not Determined 3/24/2015 Treatment of mesothelioma. Aduro BioTech, Inc.1599

n/a 5/4/2015 Treatment of pancreatic cancer Lokon Pharma AB1600

lomitapide n/a 3/3/20111601

lonafarnib n/a 4/18/20111602

Lonafarnib n/a 11/19/2013

live attenuated E. Coli expressing Beta catenin shRNA

Treatment of Familial Adenomatous Polyposis

live E. coli Nissle bacterium modified to assimilate ammonia


Live-attenuated Listeria monocytogenes actA/inlB/human mesothelin (hMeso) Strain hMeso38

LOAd703, a modified adenovirus 5/35 containing a CMV promoter-driven transgene cassette with the human transgenes for a membrane-bound CD40 ligand (TMZ-CD40L) and full length 4-1BBL

Treatment of Familial Chylomicronemia

Aegerion Pharmaceuticals, Inc.

Treatment of Hutchinson-Gilford progeria syndrome

The Progeria Research Foundation, Inc.

Treatment of Hepatitis Delta Virus (HDV)infection

Eiger Biopharmaceuticals, Inc.


of 400



1603

n/a 2/27/2014 PROLOR Biotech, Ltd1604

losartan n/a 12/12/2011 Treatment of Marfan Syndrome1605

Ibsolvmir(R) 7/6/2011 TikoMed AB1606

Ibsolvmir 10/20/2009 TikoMed AB1607

lucerastat n/a 10/29/2015 Treatment of Fabry Disease.1608

Lucinactant Surfaxin 5/23/20061609

Lucinactant Surfaxin(R), Aerosurf(R) 10/21/2010 Treatment of cystic fibrosis.1610




long acting recombinantFactor VIIa-CTP3

Treatment and prophylaxis of bleeding episodes in patients with hemophilia A or B with inhibitors to factor VIII or factor IX

National Marfan Foundation

low molecular weight dextran sulfate

Treatment to mobilze progenitor cells prior to stem cell transplantation

low molecular weight dextran sulfate

Prevention of graft rejection during pancreatic islet transplantation

Actelion Pharmaceuticals Ltd

Prevention of bronchopulmonary dysplasia in premature infants

Windtree Therapeutics, Inc.


Treatment of bronchopulmonary dysplasia in premature infants.


Treatment of respiratory distress syndrome in premature infants.


Treatment of acute respiratory distress syndrome in adults.



of 400



1613lurbinectedin n/a 8/20/2012 Treatment of ovarian cancer PharmaMar USA, Inc.

1614

lutetium (177Lu)-edotreotide n/a 5/21/20151615

Thermodox (R) 3/17/2009 Celsion Corporation1616

n/a 9/10/20081617

MA09-hRPE cells n/a 2/2/20101618

Mafosfamide n/a 1/21/20031619

n/a 11/24/2008 Gliknik, Inc.1620

n/a 12/23/20151621

n/a 9/26/2013 CMC Contrast AB

Treatment of gastro-entero-pancreatic neuroendocrine tumors

ITG Isotope Technologies Garching GmbH

lyso-thermosensitive lipsomal doxorubicin


lysosomal enzyme N-acetylgalactosamine-6-sulfate sulfatase

Treatment of mucopolysaccharidosis Type IVA (Morquio Syndrome)

Vivendy Therapeutics LTD

Treatment of Stargardt's macular dystrophy

Astellas Pharma Global Development Inc.

Treatment of neoplastic meningitis


MAGE-A3 cancer therapeutic Trojan peptide vaccine

Treatment of MAGE-A3 expressing head and neck squamous cell carcinoma

magnesium lysinate bis eicosapentaenoate

Treatment of familial adenomatous polyposis.

Thetis Pharmaceuticals

manganese (II) chloride tetrahydrate (with L-alanine and vitamin D3 as promoters of absorption)

Use as a targeted contrast agent for diagnostic MRI for the detection and localization of focal liver lesions in patients where use of gadolinium based contrast agents may be medically inadvisable or where gadolinium based contrast agents cannot be administered


of 400



1622

n/a 2/27/20081623

Mannitol Bronchitol 2/11/2005 Pharmaxis Ltd.1624

n/a 4/27/20041625

maralixibat n/a 9/4/20131626

maribavir n/a 2/1/20071627

maribavir n/a 6/7/20111628

Marijuana n/a 5/25/19991629

marizomib n/a 9/21/2015 Treatment of malignant glioma.

Manganese superoxide dismutase mimetic

Prevention of radiation- or chemotherapy-induced oral mucositis in cancer patients

Galera Therapeutics, LLC

For use to facilitate clearance of mucus in patients with bronchiectasis and in patients with cystic fibrosis at risk for bronchiectasis

mannopentaose phosphate sulfate

Treatment of high-risk Stage II, Stage III, and Stage IV melanoma

Medigen Biotechnology Corp.

Treatment of progressive familial intrahepatic cholestasis


Prevention of cytomegalovirus viremia and disease in the populations at risk.


Treatment of clinically significant cytomegalovirus viremia and disease in at-risk patients.


Treatment of HIV-associated wasting syndrome.

Multidisciplinary Association for Psychedelic Studies, Inc.

Triphase Research & Development I Corp.


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1630

Marizomib n/a 12/13/2013 Treatment of multiple myeloma1631

masitinib n/a 7/21/2009 AB Science1632 masitinib n/a 9/14/2005 Treatment of mastocytosis AB Science1633

masitinib n/a 4/20/2005 AB Science1634

masitinib mesylate n/a 3/18/2015 AB Science1635

masitinib mesylate n/a 9/14/2015 AB Science1636

Galardin 12/5/1991 Treatment of corneal ulcers. Glycomed, Inc1637

MaxAdFVIII n/a 3/3/2003 Treatment of Hemophilia A1638

n/a 7/14/2014 Treatment of ovarian cancer ImmunoGen, Inc.1639

n/a 5/12/2016 ImmunoGen, Inc.1640 mazindol n/a 7/6/2016 Treatment of narcolepsy NLS-0 Pharma AG1641

Mazindol Sanorex 12/8/1986 Collipp, Platon J. M.D.1642

Mecamylamine Inversine 10/14/1998 Targacept, Inc.

Triphase Research and Development I Corp.

Treatment of patients with pancreatic cancer

Treatment of malignant gastrointestinal stromal tumors


Treatment of gastric cancer including cancer of the gastroesophageal junction

Matrix metalloproteinase inhibitor

GenStar Therapeutics Corporation

maytansinoid conjugated humanized monoclonal antibody against FOLRI

maytansinoid-conjugated humanized monoclonal antibody against CD37



Treatment of Tourette's syndrome.


of 400



1643mecasermin Iplex 12/3/2007 Insmed, Inc.

1644mecasermin rinfabate Iplex 7/23/2012

1645

mecasermin rinfabate n/a 9/20/2012 Premacure AB1646

Increlex 9/21/2015 Treatment of Rett Syndrome.1647

Medroxyprogesterone acetate Hematrol 2/22/20011648

Mefloquine HCl Mephaquin 7/22/1987 Mepha AG1649

n/a 9/6/2006 Caladrius Biosciences1650

Melanoma cell vaccine Canvaxin 10/13/19941651

Melanoma peptide vaccine n/a 3/29/20051652

Melanoma vaccine Melacine 12/20/1989

Treatment of myotonic dystrophy

Treatment of amyotropic lateral sclerosis

PCUT BioPartners, Inc.

Prevention of retinopathy of prematurity in premature infants born at risk for the disease

mecasermin, recombinant human insulin-like growth factor-1

Keck Graduate Institute of Applied Life Sciences

Treatment of immune thrombocytopenic purpura.

ZaBeCor Pharmaceutical Company, LLC

Treatment and prevention of chloroquine-resistant Falciparummalaria

Melanoma autologous dendritic cell vaccine

Treatment of stage IIIb through IV metastatic melanoma

Treatment of invasive melanoma.

CancerVax Corporation

Treatment of HLA-A2+ patients with stage IIB, IIC, III, and IV malignant melanoma

Bristol-Myers Squibb Research Inst

Treatment of stage III - IV melanoma.

Ribi ImmunoChem Research, Inc.


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1653

n/a 9/13/20131654

Melatonin Circadin 7/9/20041655

melatonin n/a 11/3/2016 Therapicon SrL1656

Melatonin n/a 11/15/1993 Sack, Robert, M.D.1657

melatonin n/a 4/12/2013 Scharper S.p.A.1658

melphalan n/a 11/19/2012 Treatment of retinoblastoma Icon Bioscience, Inc.1659

melphalan n/a 11/19/2012 OncoTx, LLC1660

melphalan n/a 7/14/2015 Delcath Systems, Inc.1661

n/a 3/16/2015 Oncopeptides AB1662

melphalan hydrochloride n/a 11/12/2008 Delcath Systems, Inc.1663

melphalan hydrochloride n/a 11/12/2008 Delcath Systems, Inc.

melarsoprol-hydroxypropylbetadex

Treatment of human African trypanosomiasis (sleeping sickness)

Peter Kennedy, CBE, MD, PhD, DSc, FRCP FMedSci,

Treatment of non-24-hour sleep-wake disorder in blind individuals without light perception

Neurim Pharmaceuticals, Ltd.

Treatment of smith-magenis syndrome in combination with a beta-blocker

Treatment of circadian rhythm sleep disorders in blind people with no light perception.

Treatment of neonatal hypoxic ischemic encephalopathy

Treatment of Stage IIB through IV melanoma


melphalan flufenamide hydrochloride

Treatment of plasma cell myeloma, also referred to as multiple myeloma

Treatment of patients with ocular (uveal) melanoma.

Treatment of patients with cutaneous melanoma.


of 400



1664melphalan hydrochloride n/a 5/22/2009 Delcath Systems, Inc.

1665melphalan hydrochloride n/a 9/26/2013 Delcath Systems, Inc.

1666

Menadione Sodium Bisulfite n/a 5/14/20141667

menadione sodium bisulfite n/a 5/14/20141668

menaquinone Menaquinonegold 9/4/2012 Treatment of calciphylaxis1669

menatetrenone Mk4 3/17/20111670

menatetrenone Mk4(R) 11/2/20101671



n/a 8/22/20111674

mepivacaine n/a 1/8/20071675

mepivacaine n/a 10/18/2006


Treatment of patients with hepatocellular carcinoma

For the treatment of autosomal dominant polycystic kidney disease

IC-MedTech Corporation

Treatment of autosomal dominant polycystic liver disease


Nu Science Trading, LLC



Treatment of hepatocellular carcinoma (HCC).






menatetrenone and Vitamin D3








of 400



1676

mepolizumab n/a 5/28/2004 GlaxoSmithKline LLC1677

mepolizumab n/a 7/14/2011 GlaxoSmithKline LLC1678

mesalamine Canasa 1/19/20101679

n/a 9/10/20091680

Lialda 2/27/2008 Shire1681

n/a 9/10/20151682

Nurown 2/4/20111683

n/a 9/6/2016 Curis, Inc.1684

met-enkephalin; Met-N n/a 2/18/2011 Treatment of pancreatic cancer.1685

metadoxine n/a 12/16/2013 Treatment of Fragile X Syndrome Alcobra, Inc.

For first-line treatment in patients with hypereosinophilic syndrome

Treatment of Churg-Strauss Syndrome.



mesalamine and N-acetycysteine

Treatment of pediatric patients with ulcerative colitis (inclusive through age 16 years)

Altheus Therapeutics, Inc.

mesalamine; 5-aminosalicylic acid

Treatment of ulcerative colitis in pediatric patients (revised indication 10/21/2010).

mesencephalic, astrocyte-derived neurotrophic factor

Treatment of retinal artery occlusion.


mesenchymal stromal cells secreting neurotrophic factors


BrainStorm Cell Therapeutics Ltd.

mesylate synthetic small molecule inhibitor of HDAC and PI3K

Treatment of nuclear protein in testis (NUT) midline carcinoma



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1686


metformin n/a 5/29/20141688

n/a 6/2/20161689

Methionine/L-methionine n/a 8/21/1996 Treatment of AIDS myelopathy. Genopia USA, Inc.1690

Methotrexate Amethopterin 8/28/2014 Treatment of Myasthenia Gravis1691

methotrexate n/a 8/20/2009 Orbona Pharma Ltd1692

n/a 3/18/20151693

methotrexate oral solution n/a 5/28/2015

metavert, N-hydroxy-4-(5-((4-methoxyphenyl)amino)-1,3,4-oxadiazol-2-yl)benzamide

Avenzoar Pharmaceuticals, Inc.

Treatment of pediatric polycystic ovary syndrome

EffRx Pharmaceuticals SA

methimazole and liothyronine sodium


Musli Thyropeutics Ltd

The Universtiy of Kanasa Medical Center


methotrexate oral liquid formulation

Treatment of acute lymphoblastic leukemia in pediatric patients aged 0 through 16 years.

Chesapeake Therapeutics

Treatment of acute lymphoblastic leukemia in pediatric patients (0 through 16 years of age)

Silvergate Pharmaceuticals, Inc.


of 400



1694

methotrexate oral solution n/a 8/27/20151695

Methotrexate/Azone 10/15/19901696

Methoxsalen Uvadex 10/14/1998 Therakos, Inc.1697

methoxsalen Uvadex 5/12/1994 Therakos, Inc.

Treatment of oligoarticular juvenile idiopathic arthritis (persistent oligoarthritis, psoriatic juvenile idiopathic arthritis, enthesitis-related arthritis, or undifferentiated arthritis) and polyarticular juvenile idiopathic arthritis in children 0 through 16 years of age

Silvergate Pharmaeuticals, Inc.

Methotrexate with laurocapram

Topical treatment of mycosis fungoides.

Echo Therapeutics, Ltd.

For use in conjunction with the UVAR photopheresis system to treat graft versus host disease.

For the prevention of acute rejection of cardiac allografts


of 400



1698

n/a 4/18/2011 Endotis Pharma1699

methylene blue n/a 7/24/20121700

methylene blue injection n/a 8/11/20121701

n/a 4/15/20131702

n/a 9/19/20161703

metreleptin n/a 8/22/2001

Methyl O-4-O-[2-[2-[2-[2-[[N-[(1R)-1-[[4-(aminoiminomethyl)phenyl]methyl]-2-oxo-2-(1-piperidinyl)ethyl]-N2-[(4-methoxy-2,3,6-trimethylphenyl)sulfonyl]-L-Ã?ÂÃÃ?Ã?Â&Ã?ÃÂ½Ã?ÂÃÃ?ÂÃ?ÃÂ±-aspararginyl-4-aminobutanoyl-N6-[5-[(3aS,4S,6aR)-hexahydro-2-oxo-1H-thieno[

Prevention of ischemia reperfusion injury associated wth solid organ transplantation

Treatment of methemoglobinemia


Treatment of congenital and acquired methemoglobinemia


methylparaben suberohydroxamic acid phenyl ester


TetraLogic Pharmaceuticals

methylprednisolone oral suspension

Treatment of adrenal insufficiency in pediatric patients

Generic Specialty Pharma

Treatment of leptin deficiency secondary to generalized lipodystrophy and partial familial lipodystrophy

Aegerion Pharnaceuticals, Inc.


of 400



1704 metronidazole n/a 9/17/2008 Treatment of pouchitis Avivia Project BV1705

Metronidazole Metrogel 10/24/1991 Treatment of perioral dermatitis.1706

metronidazole n/a 4/26/2011 Treatment of pouchitis.1707

metronidazole n/a 4/5/20161708

Metronidazole 10% ointment n/a 11/8/2007 SLA Pharma (UK) Ltd1709

metyrapone n/a 9/25/20121710

metyrosine Demser 7/25/20081711

mexiletine n/a 9/2/20101712

mibefradil n/a 8/25/2009 Cavion, LLC1713

mibefradil n/a 10/16/2008 Treatment of pancreatic cancer. Cavion, LLC1714 mibefradil n/a 6/15/2007 Treatment of ovarian cancer Cavion, LLC1715

miconazole n/a 5/22/20141716

Microbubble contrast agent 11/16/1990 Cav-Con, Inc.

Galderma Laboratories, Inc.

S.L.A. Pharma Limited (UK)

Treatment of clostridium difficile infection in pediatric patients (0 through 16 years of age).

Appili Therapeutics, Inc.

Topical treatment of active perianal Crohn's disease

Treatment of Cushing's syndrome

Laboratoire HRA Pharma

Treatment of velocardiofacial syndrome associated psychosis.

Cerberus Princeton, LLC

Treatment of nondystrophic myotonia

University of Rochester Medical Center


Treatment of fungal otitis externa (otomycosis)

Hill Dermaceuticals, Inc.

Filmix Neurosonographic Contrast Agent

Intraoperative aid in the identification and localization of intracranial tumors.


of 400



1717

n/a 1/25/2007 Thrombotargets Corp.1718

n/a 10/11/2007 Thrombotargets Corp.1719

midazolam n/a 7/24/20121720

midazolam n/a 10/20/20091721

midazolam n/a 2/8/20161722

midazolam n/a 2/18/2016 Treatment of status epilepticus

Microvesiculated modified glycosylated tissue factor

Treatment of non-life threatening, mild to severe bleeding episodes due to cutaneous injuries or dental procedures in hemophiliac patients

Microvesiculated modified glycosylated tissue factor

Treatment of non-life threatening, mild to severe bleeding episodes due to cutaneous injuries or dental procedures in patients with von Willebrand disease.

Treatment of nerve agent-induced seizures

Meridian Medical Technologies, Inc.

Rescue treatment of seizures in patients who require control of intermittent bouts of increased seizure activity (e.g. acute repetitive seizures, seizure clusters)

Upsher-Smith Laboratories, Inc.

Treatment of seizures induced by organophosporous insecticide poisoning.


Shire Development LLC


of 400



1723

midazolam n/a 5/8/2006 UCB, Inc1724

midazolam n/a 2/4/2016 Treatment of status epilepticus1725

Midostaurin n/a 7/7/20091726 Midostaurin Rydapt 4/30/2010 Treatment of mastocytosis Novartis Oncology1727

mifamuritide Junovan 6/5/2001 Treatment of osteosarcoma1728

mifepristone Korlym 1/14/2016 Treatment of ovarian cancer.1729

Mifepristone n/a 2/7/2005 HRA Pharma1730

migalastat hydrochloride n/a 2/25/2004 Treatment of Fabry Disease1731

miglustat Zavesca (R) 11/12/20081732

milatuzumab n/a 6/24/2008 Immunomedics, Inc.

Treatment of bouts of increased seizure activity in selected refractory patients with epilepsy who are on stable regimens of anti-epileptic drugs and who require intermittent use of midazolam





Corcept Therapeutics, Inc.

Treatment of Cushing's syndrome secondary to ectopic ACTH secretion

Amicus Therapeutics, Inc.

Treatment of the neurological manifestations of Niemann-Pick disease,type C.




of 400



1733milatuzumab n/a 3/10/2008 Treatment of multiple myeloma Immunomedics, Inc.

1734milciclib maleate n/a 9/20/2012

1735

miltefosine Miltex/Impavido 3/18/20091736

Minnelide Minnelide (Tm) 2/18/2013 Treatment of pancreatic cancer1737

Minocycline hydrochloride n/a 3/28/2006 Treatment of sarcoidosis1738

misoprostol Gymiso 1/10/20051739

Mitoguazone Apep 3/18/1994 ILEX Oncology, Inc.1740

Mitolactol n/a 1/23/1989 Targent, Inc..

Treatment of thymic epithelial tumors.

Tiziana Life Sciences PLC

Topical treatment of cutaneous lymphoma encompassing cutaneous manifestations of T-cell lymphoma and B-cell lymphoma

ExperGen Drug Development GmbH

Minneamrita Therapeutics, LLC

Autoimmunity Research Foundation

Treatment of intrauterine fetal death not accompanied by complete expulsion of the products of conception in the second and third trimesters of pregnancy.

Gynuity Health Projects, LLC

Treatment of diffuse non-Hodgkin's lymphoma, including AIDS-related diffuse non-Hodgkin's lymphoma.

Treatment of invasive carcinoma of the uterine cervix


of 400



1741

Mitolactol n/a 7/12/1995 Targent, Inc.1742

mitomycin n/a 1/13/20111743

mitomycin n/a 6/1/20111744

mitomycin Mitogel 9/8/2014 TheraCoat, Ltd.1745

Mitomycin-C n/a 8/20/1993 IOP Inc.1746

n/a 10/7/20151747

n/a 2/4/20111748

n/a 2/4/20111749

Cea-Cide 11/24/1998 Treatment of pancreatic cancer. Immunomedics, Inc.

As adjuvant therapy in the treatment of primary brain tumors.

Prevention of recurrence of pterygium after its surgical excision.

Mobius Therapeutics, LLC

Prevention of corneal sub-epithelial haze formation following surface ablation laser keratectomy


Treatment of upper tract urothelial cell cancers (transitional cell carcinoma of the renal pelvis and ureter)

Treatment of refractory glaucoma as an adjunct to ab externo glaucoma surgery.

Mixture of 2 anti-rabies humanized monoclonal immunoglobulin (Ig)G1k antibodies

Post-exposure prophylaxis against rabies virus infection

Synermore Biologics Co., Ltd

MLN4924-Inhibitor of Nedd8-activating enzyme (NAE)

Treatment of acute myelogenous leukemia.

Millennium Pharmaceuticals

MLN4924-Inhibitor of Nedd8-activating enzyme (NAE)

Treatment of Myelodysplastic syndrome


MN14 monoclonal antibody to carcinoembryonic antigen


of 400



1750

Cea-Cide 9/18/1998 Immunomedics, Inc.1751

Mocetinostat n/a 6/12/20141752

mocetinostat n/a 8/7/20141753

MOD-423 hGH analogue n/a 9/29/2010 OPKO Biologics Ltd.1754

modified a-cobratoxin n/a 9/1/20151755

n/a 4/8/2015 Treatment of uveal melanoma Aura Biosciences, Inc.1756

n/a 7/5/20161757

n/a 1/17/2013 Treatment of achondroplasia1758

n/a 8/20/2012 Gencia Corporation

MN14 monoclonal antibody to carcinoembryonic antigen



Mirati Therapeutics, Inc.




Treatment of pediatric multiple sclerosis (0 through 16 years of age).

Nutra Pharma Corporation

modified human papillomavirus capsid protein conjugated to a near infrared dye

modified mRNA encoding UGT1A1 protein, formulated in lipid nanoparticles

Treatment of Crigler-Najjar syndrome


modified recombinant human C-type natriuretic peptide (CNP)


modified recombinant mitochondrial transcription factor A (TFAM) containing the mitochondrial transduction domain

Treatment of inherited mitochondrial respiratory chain disease


of 400



1759

mogamulizumab n/a 11/2/20101760



monarsen n/a 11/14/2003 Treatment of myasthenia gravis Bioline Rx, Ltd.1763

mongersen n/a 7/20/2015 Celgene Corporation1764

monoclonal antibody 11-1F4 n/a 12/7/2009 Alan Solomon, M.D.1765

monoclonal antibody 11-1F4 n/a 12/11/2009 Alan Solomon, M.D.1766

monoclonal antibody 3F8 n/a 10/16/2008 Treatment of neuroblastoma1767

n/a 8/25/2014 LeafBio, Inc.

Treatment of peripheral T-cell lymphoma.

Kyowa Kirin Pharmaceutical Development, Inc.

Treatment of patients with cutaneous T-cell lymphoma.

Kyowa Kirin Pharmaceutical Development Inc.

Treatment of adult T-cell leukemia/lymphoma (ATLL).

Kyowa Kirin Pharmaceutical Development, Inc.


For use as a radioimmaging agent in amyloidosis

For use as a therapeutic agent for patients AL amyloidosis.

United Therapeutics Corporation

monoclonal antibody consisting of three mouse/human chimeric IgG1 monoclonal antibodies (c2G4, c4G7, and c13C6) that target Ebola virus

Treatment of Ebola virus infection


of 400



1768

n/a 11/4/20131769

n/a 1/7/1993 Treatment of lupus nephritis.1770

monoclonal antibody Hu3F8 n/a 1/10/2014 Treatment of osteosarcoma1771

n/a 10/29/2015 ChemomAb, Ltd.1772

n/a 1/6/2015 Treatment of systemic sclerosis ChemomAb, Ltd.1773

Monoclonal antibody-B43.13 Ovarex Mab-B43.13 11/25/19961774

Monolaurin Glylorin 4/29/1993 Glaxo Wellcome Inc.1775

U-Cord-Cell(R) 9/15/20151776

motexafin gadolinium Xcytrin 1/27/2003 Pharmacyclics, LLC1777

n/a 3/24/2015

monoclonal antibody directed at hepatitis C virus E2 glycoprotein

Prevention of Hepatitis C recurrence in patients receiving liver transplantation

MassBiologics-University of MA Medical School

Monoclonal antibody for immunization against lupus nephritis

VivoRx Autoimmune, Inc.


monoclonal antibody targeting eotaxin-2


monoclonal antibody targeting eotaxin-2

Treatment of epithelial ovarian cancer.

Quest PharmaTech, Inc.

Treatment of congenital primary ichthyosis.

Mononuclear enriched fraction of human umbilical cord blood


Saneron CCEL Therapeutics, Inc.

For use in conjunction with whole brain radiation for the treatment of brain metastases arising from solid tumors

mouse-human chimeric antibody of the IgG1 isotype, directed against human CD37

Treatment of chronic lymphocytic leukemia (CLL).



of 400



1778

n/a 9/20/2012 Treatment of neuroblastoma. APEIRON Biologics AG1779

moxetumomab pasudotox n/a 11/15/2007 Treatment of hairy cell leukemia MedImmune, LLC1780

moxetumomab pasudotox n/a 6/28/2013 MedImmune, LLC1781

moxetumomab pasudotox n/a 11/15/2007 MedImmune, LLC1782

moxidectin n/a 9/29/20101783

mPEG-r-crisantaspase Asparec(Tm) 2/1/20101784

n/a 11/23/2016 PhaseRx, Inc.1785

MTC-DOX for Injection n/a 1/3/2001 FeRx Incorporated1786


n/a 12/7/2015 Treatment of ovarian cancer. Tapimmune, Inc.

mouse-human chimeric monoclonal anti-GD2 IgG1 antibody


Treatment of CD22-positive chronic lymphocytic leukemia

Treatment of onchocerciasis volvulus in children and adults.

Medicines Development Limited

Treatment of acute lymphoblastic leukemia.


mRNA encoding human ornithine transcarbamylase

Treatment of ornithine transcarbamylase deficiency


mTOR kinase inhibitor (CC-223)


multi-epitope folate receptor alpha peptide vaccine with GM-CSF adjuvant (TPIV200)


of 400



1788

n/a 7/27/20041789

Multi-peptide cancer vaccine n/a 6/23/2013 Treatment of multiple myeloma OncoPep, Inc.1790

n/a 12/12/19891791

Multistem(r) n/a 9/15/2010 Athersys, Inc.1792

Oncolym 11/27/19981793

Theragyn 3/22/1999 Antisoma plc1794

Begedina 2/18/2011 Adienne S.A.

Multi-ligand somatostatin analog

Treatment of patients with functional gastroenteropancreatic (GEP) neuroendocrine tumors (specifically, carcinoid, insulinoma, gastrinoma, somastatinoma, GRFoma, VIPoma and glucagonoma.


Multi-vitamin infusion (neonatal formula)

For establishment and maintenance of total parenteral nutrition in very low birth weight infants.

Astra Pharmaceuticals, L.P.

Prophylaxis of graft vs host disease

Murine MAb (Lym-1) and Iodine 131-I radiolabeled murine MAb (Lym-1) to human B-cell lymphoma

Treatment of B-cell non-Hodgkin's lymphoma.

Peregrine Pharmaceuticals, Inc.

Murine MAb to polymorphic epithelial mucin, human milk fat globule 1

Adjuvant treatment of ovarian cancer.

murine monoclonal antibody against CD26



of 400



1795

n/a 9/23/2014 Treatment of Neuroblastoma1796

Mx-dnG1 Rexin-G 6/24/2008 Treatment of osteosarcoma.1797

Mx-dnG1 Rexin-G(R) 6/24/2008 Treatment of soft tissue sarcoma1798

Rexin-G 8/15/2003 Treatment of pancreatic cancer1799

n/a 10/11/1995 Statens Seruminstitut1800

mycobacterium vaccae n/a 8/20/2010 Treatment of tuberculosis1801

myo-inositol n/a 4/7/2005 Abbott Nutrition1802

n/a 10/29/2015 Treatment of malaria.

MV-NB-02, its bivalent ganglioside vaccine consisting of GD2-lactone and GD3-lactone each covalently conjugated to keyhole hemocyanin

MabVax Therapeutics, Inc.

Epeius Biotechnologies Corporation


Mx-dnG1 or Rexin-G retroviral vector


Mycobacterium avium sensitin RS-10

For use in the diagnosis of invasive Mycobacterium avium disease in immunocompetent individuals.

Immodulon Therapeutics Ltd

Prevention of retinopathy of prematurity in preterm infants at risk for developing retinopathy of prematurity

N'-(7-Chloroquinolin-4-yl)-N,N-diethyl-propane-1,3-diamine

Donald J. Krogstad, MD


of 400



1803

n/a 4/6/2012 Treatment of mercury toxicity CTI Science Limited1804

n/a 11/17/20141805

n/a 11/17/2014 Treatment of optic neuritis Bionure Farma SL1806

n/a 8/8/20071807

n/a 2/1/2008

N,N'-bis(2-mercaptoethyl)isophthalamide (NBMI)

N-(2-((4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenamido)ethyl)-2-hydroxybenzamide


Catabasis Pharmaceuticals, Inc.

N-(2-amino-2-oxoethyl)-2-(2-((4-fluorophenethyl)amino)-N-isobutylacetamido)-N-(3-(2-oxopyrrolidin-1-yl)propyl)acetamide N-({Carbamoylmethyl-[3-(2-oxo-pyrrolidin-1-yl)propyl}-carbamoyl}-methyl)-2-[2-(2-fluorophenyl)-ethylamino]-N-isobutyl-acetamide

N-(2-amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl] benzamide dihydrobromide

Treatment of Hodgkin's lymphoma


N-(2-amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl] benzamide dihydrobromide




of 400



1808n/a 10/15/2014 Treatment of AL Amyloidosis ProteoTech, Inc.

1809

n/a 11/26/2013 Treatment of gliomas1810

n/a 7/6/2012 BioLineRx, Ltd.1811


n/a 10/21/2014 Treatment of ovarian cancer Amgen, Inc.1813

n/a 3/18/2009

N-(3,4-dihydroxyphenyl)-3,4-dihydroxybenzamide

N-(3-fluorobenzyl)-2-(5-(4-morpholinophenyl) pyridin-2-yl) Acetamide Besylate

Kinex Pharmaceuticals, Inc.

N-(4-Fluoro-benzoyl)-L-arginyl-L-arginyl-[L-3-(naphthyl-alanyl]-L-cysteinyl-L-tyrosyl-L-citrullinyl-L-lysyl-D-lysyl-L-prolyl-L-trosyl-L-arginyl-L-citrullinyl-L-cysteinyl-L-aginine amide, cyclic (4-13)-disulfide

For use to mobilize hematopoietic stem cells (HSCs) from the marrow to peripheral blood for collection for autologous or allogeneic transplantation

N-(4-Methoxyphenyl)-N,2,6-trimethylfuro[2,3-d] pyrimidin-4-amine

Flag Therapeutics, Inc.

N-(4-{3-(2-aminopyrimidin-4-yl)pyridin-2-yl]oxy}phenyl)-4-(4-methylthiophen-2-yl)phthalazin-1-amine bis-mesylate dihydrate

N-(5-tert-Butylisoxazol-3-yl)-N'-{4-[7-(2-(morpholin-4-yl)ethoxy) imidazo[2,1-b][1,3]benzothiazol-2-yl]phenyl}urea di-hydrochloride salt


Daiichi Sankyo Pharma Development


of 400



1814

n/a 11/17/20141815

n/a 8/5/2010 Treatment of myelofibrosis Gilead Sciences, Inc.1816

n/a 10/17/2005 Treatment of multiple myeloma. AB Science1817

N-acetyl cysteine amide n/a 12/31/20131818

n/a 2/6/2006 ExSAR Corporation1819

N-acetyl-procainamide n/a 12/10/1996 NAPA of the Bahamas1820

N-acetylcysteinate Lysine 12/27/2000

N-(9-methoxynonyl)-1-deoxynojirimycin hydrochloride

Treatment of acute dengue illness (inclusive of acute dengue illness, dengue fever, dengue hemorrhagic fever, and dengue shock syndrome)

Emergent Virology, LLC

N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl(phenyl]amino}pyrimidin-4-yl)benzamide

N-(methyl-diazacyclohexyl-methylbenzamide)-azaphenyl-aminothiopyrrole) mesylate


Nacuity Pharmaceuticals, Inc.

N-acetyl-glucosamine thiazoline

Treatment of adult Tay-Sachs disease

Prevention of life-threatening ventricular arrhythmias in patients with documented procainamide-induced lupus.

Nacystelyn Dry Powder Inhaler

For the management of cystic fibrosis

Galephar Pharmaceutical Research, Inc.


of 400



1821

N-acetylcysteine n/a 7/19/20121822

N-acetylcysteine n/a 9/9/2002 Treatment of acute liver failure1823

n/a 8/31/20151824

n/a 4/5/20101825

n/a 10/16/2007 Treatment of tuberculosis. Sequella, Inc.1826

n/a 1/13/2012 Treatment of meningioma1827

n/a 1/13/20121828

N-Methanocarbathymidine n/a 10/15/2014 Treatment of neonatal herpes

Prevention of ototoxicity caused by platinum-based chemotherapeutic agents used to treat pediatric cancers


Cumberland Pharmaceuticals, Inc.

N-acetylcysteine and sodium thiosulfate

Prevention of platinum-induced toxicities in pediatric patients (0 through 16 years of age).


N-Acetylmannosamine (ManNAc)

Treatment of hereditary inclusion body myopathy type 2

Escala Therapeutics, Inc.

N-adamantanyl-N'-Geranyl-ethylenediamine

N-Hydroxy-4-(3-methyl-2-(S)phenyl-butyrylamino)benzamide

Arno Therapeutics, Inc.

N-Hydroxy-4-(3-methyl-2-(S)phenyl-butyrylamino)benzamide

Treatment of Schwannoma of the central nervous system

Arno Therapeutics, Inc.

N & N Pharmaceuticals, Inc.


of 400



1829

n/a 7/18/2013 Treatment of mesothelioma Verastem, Inc.1830

N-t-butylhydroxylamine n/a 5/12/2015 Andrew Lim1831

n/a 3/21/2013 Treatment of polycythemia vera1832

n/a 5/18/20091833

n/a 1/29/2010 Treatment of pancreatic cancer EMD Serono, Inc.

N-methyl-4-({4-[({3-methyl(methylsulfonyl)amino]pyrazin-2-yl}methyl)amino]-5-(trifluoromethyl)pyrimidin-2-yl}amino)benzamide hydrochloride

Treatment of infantile neuronal ceroid lipofuscinosis.

N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate

sanofi-aventis U.S. LLC

N-tert-butyl-3-[5-methyl-2-{[4-(2-pryyolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl-amino] benzenesulfonamide dihydrochloride monohydrate

Treatment of secondary and primary myelofibrosis

Sanofi-Aventis US, LLC a Sanofi company

N-[(2S)-2,3-dihydroxypropyl]-3-[(2-fluoro-4-iodophenyl)amino] isonicotinamide hydrochloride


of 400



1834

n/a 1/12/2011 EMD Serono, Inc.1835

n/a 1/7/20151836

n/a 12/27/2006 CytRx Corporation1837

n/a 5/25/1995 Treatment of malignant glioma. Sugen, Inc.1838

n/a 3/12/1996 Treatment of ovarian cancer. Sugen, Inc.

N-[(2S)-2,3-dihydroxypropyl]-3-[(2-fluoro-4-iodophenyl)amino] isonicotinamide hydrochloride

Treatment of acute myeloid leukemia (AML).

N-[2,6-bis(1-methylethyl)phenyl]-N'-[[1-[4-(dimethylamino)phenyl]cyclopentyl]methyl]urea, hydrochloride salt

For the treatment of Cushing's Syndrome

Millendo Therapeutics, Inc.

N-[3-(4',5'-bipyrimidin-2-ylamino)-4-methylphenyl]-4-{[(3S)-3-(dimethylamino)pyrrolidin-1-yl]methyl}-3-(trifluoromethyl)benzamide

Treatment of Philadelphia chromosome-positive chronic myelogenous leukemia.

N-[4-(trifluoromethyl)phenyl] 5 methylisoxazole-4-carboxamide

N-[4-(trifluoromethyl)phenyl]-5-methylisoxazole-4-carboxamide


of 400



1839

n/a 2/3/2015 Ignyta, Inc.1840

n/a 2/12/2015 Ignyta, Inc.1841

n/a 2/4/2011 Treatment of tuberculosis. Sequella, Inc.1842

n/a 8/7/2014 Treatment of pancreatic cancer Sun BioPharma, Inc.1843

n/a 12/7/2000 For pancreatic cancer1844


nabumetone n/a 5/5/2008 Cook Pharma

N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methylpiperazin-1yl)-2-(tetrahydro-2H-pyran-4-ylamino)benzamide

Treatment of TrkA-positive, TrkB-positive, TrkC-positive ROS1-positive or ALK-positive non-small cell lung cancer

N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methylpiperazin-1yl)-2-(tetrahydro-2H-pyran-4-ylamino)benzamide

Treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive, or ALK-positive colorectal cancer

N-{[(5S)-3-(3-fluoro-4-thiomorpholin-4-ylphenyl)-2-oxo-1,3-oxazolidin-5-yl]methyl}acetamide

N1,N14,-diethyl-3,12,-dihydroxyhomospermine

N2'-deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maystansine-Conjugated Humanized C242 Monoclonal Antibody

SmithKline Beecham Pharmaceuticals

N2'-Deacetyl-N2'-[4-methyl-4-(oxobuthyldithio)-1-oxopentyl]-maytansine-chimerized anti-CD138 IgG4 Monoclonal Antibody


Treatment of pediatric juvenile rheumatoid arthritis


of 400



1846

naloxone n/a 11/23/2010 Elorac, Inc.1847

naltrexone n/a 1/19/2010 TNI BioTech, Inc.1848

naltrexone n/a 2/23/20151849

naltrexone n/a 1/13/20151850

n/a 4/14/20141851


n/a 7/9/20151853

n/a 5/23/2016 Treatment of ovarian cancer. PeptiMed1854

NanoDTPA(tm) n/a 6/17/2011

Topical treatment of pruritus associated with mycosis fungoides

Treatment of Crohn's disease in pediatric patients


Allodynic Therapeutics LLC

Treatment of autoimmune hepatitis

TaiwanJ Pharmaceuticals Co., Ltd.

naltrexone/clonidine combination


Allodynic Therapeutics LLC

nano-diamino-tetraiodothyroacetic acid

NanoPharmaceuticals, LLC

nano-diamino-tetraiodothyroacetic acid

Treatment of glioblastoma multiforme (GBM)

NanoPharmaceuticals, LLC

Nanocomplex consisting of a small interfering RNA that targets the human EV11 oncogenic transcription factor and an elastin-like polypeptide drug carrier.

Treatment of known or suspected cases of internal contamination with plutonium, americium, or curium

Nanotherapeutics, Inc.


of 400



1855

Edroma 11/29/2016 Treatment of Glioma1856 nanoparticulate paclitaxel Nanotax 10/6/2015 Treatment of ovarian cancer NanOlogy, LLC1857

napabucasin n/a 10/25/2016 Treatment of pancreatic cancer.1858

napabucasin n/a 6/20/20161859

naproxcinod n/a 3/16/2015 Nicox SA1860


n/a 1/18/2000 Treatment of Behcet's disease1862

n/a 8/10/20001863

NDX-peptides n/a 12/14/20101864

Nebacumab Centoxin 10/1/1986 Centocor, Inc.1865

nelarabine n/a 9/2/1999

nanoparticles containing Zoledronic acid

Laboratorio Italiano Biochimico Farmaceutico Lisapharma SpA

Boston Biomedical, Inc.

Treatment of gastric cancer including gastroesophageal junction cancer.

Boston Biomedical, Inc.


natural human lymphoblastoid interferon-alpha

Amarillo Biosciences, Inc.

Natural human lymphoblastoid interferon-alpha


Natural human lymphoblastoid interferon-alpha

Treatment of papillomavirus warts in the oral cavity of HIV positive patients.



NeoDiagnostic Research Ltd

Treatment of patients with gram-negative bacteremia which has progressed to endotoxin shock.




of 400



1866

neostigmine n/a 3/18/20131867

neostigmine methylsulfate n/a 2/17/2012 Treatment of Myasthenia Gravis1868

neridronate n/a 3/25/2013 Grunenthal USA, Inc.1869

Neurotrophin-1 n/a 9/13/19941870

Cylexin 12/22/1993 Cytel Corporation1871

nevirapine n/a 11/25/20091872

n/a 11/9/2016 Gamida Cell Ltd.1873

Nifedipine n/a 6/13/1991 Treatment of interstitial cystitis.

Treatment of acute colonic pseudo-obstruction



Treatment of complex regional pain syndrome (CRPS-1, CRPS-II, CRPS-NOS)

Treatment of motor neuron disease/amyotrophic lateral sclerosis.

Ericsson, Arthur Dale, M.D.

Neutrophil-endothelial interaction inhibitor

Treatment of post-ischemic pulmonary reperfusion edema following surgical treatment for chronic thromboembolic pulmonary hypertension.

Prevention of HIV infection in pediatric patients under the age of 16 years

Auritec Pharmaceuticals

NiCord (cord blood-derived exvivo expanded CD34+ cells and the non-expanded cell fraction of the same cord blood unit)

Treatment of chronic myelogenous leukemia (CML)

Fleischmann, Jonathan M.D.


of 400



1874

nifurtimox Lampit 8/5/20101875

nifurtimox n/a 12/31/2013 Treatment of Chagas disease1876

Nikkomycin Z n/a 2/14/2006 Treatment of coccidioidomycosis1877

nimotuzumab n/a 9/8/2015 Treatment of pancreatic cancer. InnoCIMab Pte Ltd1878 Nimotuzumab n/a 11/17/2004 Treatment of glioma InnoKeys PTE Ltd.1879

n/a 9/3/2004 The Vaccine Company1880



nintedanib n/a 7/6/20161883

niprisan Hemoxin 8/15/2003 Treatment of sickle cell disease1884 niraparib n/a 4/30/2010 Treatment of ovarian cancer TESARO, Inc.1885

nitazoxanide Cryptaz 10/23/2001

Treatment of Chagas disease (American Typanosomiasis)caused by T. cruzi


MetronomX Therapeutics, LLC

Valley Fever Center for Excellence (1-111 INF)

Nine amino acid polypeptide derived from proteinase 3

Treatment of myelodysplastic syndromes requiring therapy





Treatment of systemic sclerosis (including the associated interstitial lung disease).


Xechem International, Inc.

Treatment for intestinal amebiasis

Romark Laboratories, L.C.


of 400



1886Nitisinone Orfadin 10/19/2001 Treatment of alkaptonuria Swedish Orphan AB

1887

Nitric oxide Inomax 9/27/2004 INO Therapeutics1888 Nitric oxide n/a 9/11/2013 Treatment of cystic fibrosis Novoteris, LLC1889

nitric oxide Inomax (R) 9/5/2008 INO Therapeutics1890

nitric oxide Inomax 12/28/20111891

Nitric oxide n/a 2/16/2005 Diagnosis of sarcoidosis1892

nitric oxide n/a 9/23/2014 Treatment of cystic fibrosis1893

Nitric oxide n/a 7/10/1995 INO Therapeutics, Inc.1894

nitric oxide n/a 6/18/2012 GeNO, LLC1895

Nitroprusside n/a 2/21/20011896

nivolumab Opdivo(R) 9/2/2015

To reduce the risk of chronic lung disease in premature neonates

Use in combination with a drug delivery device for acute treatment of sickle cell vaso-occlusive crisis (pain crises)


Bellerophon Therapeutics

SensorMedics Corporation

Advanced Inhalation Therapies Ltd.

Treatment of acute respiratory distress syndrome in adults.

Treatment of persistent pulmonary hypertension in newborns

Treatment and prevention of cerebral vasospasm following subarachnoid hemorrhage.

Thomas, MD, Jeffrey Evan




of 400



1897nivolumab n/a 9/15/2015

1898nivolumab n/a 8/27/2015 Treatment of glioblastoma

1899nivolumab Opdivo 8/22/2016 Treatment of esophageal cancer

1900

n/a 12/15/20141901

At001 12/3/20141902

n/a 5/24/20161903

n/a 12/8/2015 REGENXBIO, Inc.



Bristol-Myers Squibb Co


non-peptide small molecule orally available agonist of the parathyroid hormone receptor type I

Treatment of hypoparathyroidism

Chugai Pharma USA, LLC

non-replicating adeno-associated viral vector, serotype 8, expressing human myotubularin gene

Treatment of x-linked myotubular myopathy


non-replicating recombinant adeno-associated viral vector, serotype 8, expressing the 1A1 isoform of the bilirubin-uridine diphosphate glucuronosyltransferase gene

Treatment of Crigler Najjar syndrome.


non-replicating recombinant adeno-associated virus (AAV) vector of serotype 9 expressing human iduronate-2-sulfatase

Treatment of Mucopolysaccharidosis Type II


of 400



1904

n/a 10/20/20141905

n/a 12/31/2013 US Biotest, Inc.1906

n/a 1/31/2014 US Biotest, Inc.1907

noscapine n/a 12/29/2015 KineMed Inc.1908

n/a 9/10/2009 Antisoma, Inc.1909


n/a 7/28/2005 Antisoma Inc.1911

nusinersen n/a 4/18/2011 Biogen, Inc.1912

n/a 1/15/2013 Vudbenk Life Sciences

non-replicating recombinant adeno-associated virus vector containing a fragment of the gene encoding channelrhodopsin-2 protein


RetroSense Therapeutics, LLC

NorLeu3-Angiontensin(1-7)) [NorLeu3-A(1-7)]

Treatment of leakage from the surgical site following penetrating keratoplasty

NorLeu3-Angiotensin(1-7) [NorLeu3-A(1-7)]

Treatment of dermal injury due to nuclear/radiation incident


Nucleic acid aptamer binding to tumor cell nucleolin


Nucleic acid aptamer binding to tumor cell nucleolin

Antisoma Research Ltd.

Nucleic acid aptamer binding to tumor cell nucleon



O-(3-piperidino-2-hydroxyl-1-propyl)-nicotinic acid amidoxime hydrochloride



of 400



1913

n/a 3/16/2012 JSK Therapeutics, Inc.1914

n/a 12/13/2013 Treatment of multiple myeloma JSK Therapeutics, Inc.1915

obinutuzumab n/a 2/17/2012 Genentech, Inc.1916

oblimersen Genasense 8/28/2001 Genta, Inc.1917

oblimersen Genasense 8/28/2001 Treatment of multiple myeloma Genta, Inc.1918



octreotide Sandostatin Lar 8/5/20101921

octreotide (oral) Octreolin(Tm) 6/17/2010 Chiasma, Inc.1922


oglufanide disodium n/a 9/24/2001 Treatment of ovarian cancer

O2-(2,4-dinitrophenyl) 1-[(4-ethoxycarbonyl)piperazin-1-yl]diazen-1-ium-1,2-diolate


O2-(2,4-dinitrophenyl) 1-[(4-ethoxycarbonyl)piperazin-1yl]diazen-1-ium-1,2-diolate

Treatment of diffuse large B cell lymphoma

Treatment of acute myelocytic leukemia


Treatment of advanced malignant melanoma (Stages II,III, IV).



For the oral treatment of acromegaly

octreotide acetate subcutaneous implant

Endo Pharmaceuticals Solutions, Inc.

Implicit Bioscience Pty Ltd


of 400



1924

olaptesed pegol n/a 8/19/2014 Noxxon Pharma AG1925

oleylphosphocholine n/a 10/25/2013 Treatment of leishmaniasis1926

n/a 2/2/20161927

n/a 2/27/20141928

olipudase alfa n/a 8/3/2000 Genzyme Corporation1929

omacetaine mepesuccinate n/a 1/12/20091930

Technivie® Tablets 2/24/2016 AbbVie Inc.1931

Viekira Pak 7/16/2015 Abbvie, Inc.1932

n/a 3/3/2011 Treatment of soft tissue sarcoma1933

n/a 11/22/1995

Treatment of glioblastoma in conjunction with radiotherapy.

Dafra Pharma International nv

oligodendrocyte progenitor cells


Asterias Biotherapeutics

oligopeptide containing 6 amino acids (H-Phe-Ser-Arg-Tyr-Ala-Arg-OH)


Genervon Biopharmaceuticals, LLC

Treatment of acid sphingomyelinase deficiency (Niemann-Pick disease)

Treatment of myelodysplastic syndromes

IVAX International GmbH

Ombitasvir/Paritaprevir/Ritonavir

Treatment of pediatric patients with chronic hepatitis C virus infection

ombitasvir/paritaprevir/ritonavir and dasabuvir

Treatment of pediatric patients with hepatitis C virus infection (0 through 16 years of age)

ombrabulin; N-{2-methoxy-5-[(Z)-2-(3,4,5-trimethozyphenyl)vinyl]phenyl}-L-serinamide hydrochloride

Sanofi-Aventis U.S., Inc.

Omega-3 (n-3) polyunsaturated fatty acid with all double bonds in the cis configuration

Prevention of organ graft rejection.

Research Triangle Pharmaceuticals


of 400



1934Omacor 5/4/2000 Treatment of IgA nephropathy. Pronova Biocare, AS

1935

Omegaven emulsion Omegaven 2/27/20081936

n/a 2/10/2015 Treatment of esophageal ulcers1937

omigapil n/a 6/24/20081938

n/a 12/22/2014 Oncos Therapeutics1939 oncophage n/a 4/14/2009 Treatment of glioma Agenus, Inc.1940

n/a 10/14/20151941

opioid growth factor n/a 4/16/20131942

opium tincture n/a 12/2/2011

Omega-3 (n-3) polyunsaturated fatty acids

Treatment of parenteral nutrition-associated liver disease

Fresenius Kabi Deutschland GmbH

omeprazole-lansoprazole with buffer

Effexus Pharmaceuticals, LLC

Treatment of congenital muscular dystrophy.


Oncolytic adenovirus coding for granulocyte macrophage colony stimulating factor (ONCOS-102)


ondansetron inhalation powder

Prevention of chemotherapy-induced nausea and vomiting due to highly emetogenic chemotherapy in pediatric patients (0 through 16 years of age) .

Luxena Pharmaceuticals, Inc.

Treatment of liver and intrahepatic bile duct cancer

Primocure Pharma, Inc.

Treatment of chronic diarrhea in short bowel syndrome patients with an inadequate response to anti-diarrheal treatment

Valeant Pharmaceuticals International, Inc.


of 400



1943oprozomib n/a 8/25/2014

1944oprozomib n/a 10/28/2014 Treatment of multiple myeloma

1945

n/a 8/20/2012 Treatment of narcolepsy1946

oral testosterone n/a 6/2/2016 TesoRx Pharma, LLC1947

oral unfractionated heparin n/a 1/29/2004 Treatment of sickle cell disease TRF Technologies, Inc.1948

osilodrostat n/a 9/13/2013 Treatment of Cushing's disease1949

otelixizumab n/a 2/6/2006 GlaxoSmithKline1950

n/a 12/23/20141951 Oxaliplatin n/a 10/6/1992 Treatment of ovarian cancer. Debio Pharm S.A.1952 oxaloacetate n/a 7/24/2012 Treatment of gliomas Terra Biological LLC1953

Oxaloacetic acid n/a 11/18/2015 Terra Biological LLC1954

Oxalobacter formigenes n/a 3/29/2006 OxThera, Inc.


Onyx Therapeutics, Inc.


optically pure phenylalanine derivative

Jazz Pharmaceuticals International III Limited

Treatment of constitutional delay of growth and puberty in adolescent boys 14 to 17 years of age.

Novartis Pharmaceuticals corporation

Treatment of new-onset type I diabetes mellitus

OTL38; conjugate of pteroi acid and S0456 near infrared dye

Detecting folic receptor alpha positive lesions in ovarian cancer patients (diagnostic for the management of ovarian cancer)

On Target Laboratories, LLC


Treatment of primary hyperoxaluria


of 400



1955

Oxandrolone Oxandrin 4/22/19971956

Oxandrolone Oxandrin 9/6/19911957

oxfendazole n/a 7/14/20141958

Oxymorphone Numorphan H.P. 3/19/19851959

Oxypurinol n/a 11/9/19981960

oxytocin n/a 11/24/2014 Pr Maithe Tauber1961

ozanimod n/a 12/29/20151962

n/a 1/9/2013 Lentigen Corporation1963

n/a 5/27/2014 Array BioPharma, Inc.

Treatment of patients with Duchenne's muscular dystrophy and Becker's muscular dystrophy.

Savient Pharmaceuticals, Inc.

Adjunctive therapy for AIDS patients suffering from HIV-wasting syndrome.

Bio-Technology General Corp.

Treatment of cysticercosis (including neurocysticercosis)

Robert H. Gilman, MD, DTMH and

For relief of severe intractable pain in narcotic-tolerant patients.

DuPont Merck Pharmaceutical Company

Treatment of hyperuricemia in patients intolerant to allopurinol.

Cardiome Pharma Corp.

Treatment of Prader-Willi syndrome

Treatment of pediatric (0 through 16 years of age) ulcerative colitis

Receptos Services, LLC

P140K MGMT transduced human CD34 cells

For bone marrow protection in the treatment of glioblastoma multiforme

p38 mitogen-activated kinase inhibitor

Treatment of dilated cardiomyopathy, including dilated cardiomyopathy secondary to lamin A/C gene mutations


of 400



1964

Paclitaxel Paxene 4/15/19971965

paclitaxel n/a 5/1/2009 Treatment of pancreatic cancer1966

paclitaxel aqueous gel Oncogel(Tm) 2/1/2008 Treatment of esophageal cancer1967

paclitaxel aqueous gel Oncogel (Tm) 12/23/2008 Treatment of brain cancer. BTG International Inc.1968

paclitaxel nanoparticles n/a 1/2/2013 Treatment of pancreatic cancer CIRJ Co., Ltd.1969

paclitaxel poliglumex Opaxio 9/20/20121970

paclitaxel, micellar Paclical 4/3/2009 Treatment of ovarian cancer1971

paclitaxel-coated buttress n/a 7/15/2014 AcuityBio, Inc.1972

pacritinib n/a 3/13/20081973

pafuramidine maleate n/a 11/17/2006


Baker Norton Pharmaceuticals, Inc.

SynCore Biotechnology Co., Ltd.

BTG International, Inc.


CTI BioPharma Corporation

Oasmia Pharmaceutical AB

For use as local administration at the time of curative surgery in the treatment of stage 0 to III non-small cell lung cancer.

Treatment of primary myelofibrosis (MF), post-polycythemia vera MF, and post-essential thrombocythemia MF


Treatment of pneumocystis jiroveci pneumonia



of 400



1974

Pafuramidine maleate n/a 5/14/2007 Treatment of malaria1975

Pafuramidine maleate n/a 8/31/20071976

palovarotene n/a 7/21/20141977

pantothenate phosphate n/a 5/4/2015 Retrophin, Inc.1978

Wobe-Mugos 12/21/1998 Treatment of multiple myeloma.1979

paquinimod n/a 1/17/2014 Treatment of systemic sclerosis Active Biotech AB1980

paromomycin n/a 2/11/20151981

n/a 1/18/20081982

n/a 10/19/2016 Serodus ASA

Immtech Pharmaceuticsl, Inc.

Treatment of human African trypanosomiasis (sleeping sickness)


Treatment of fibrodysplasia ossificans progressiva

Clementia Pharmaceuticals, Inc.

Treatment of pantothenate kinase associated neurodegeneration (PKAN).

Papain, trypsin, and chymotrypsin

Marlyn Nutraceuticals, Inc.

Treatment of cutaneous leishmaniasis (Old World and New World)

The Surgeon General, Dept. of the Army

paromomycin sulfate/gentamicin sulfate

Treatment of all uncomplicated cutaneous leishmaniasis (both New World and Old World)

Office of the Surgeon General

Partial agonist at the opioid receptor-like 1 receptor with amino acid sequence Ac-Arg-Tyr-Tyr-Arg-Trp-Lys-Lys-Lys-Lys-Lys-Lys-Lys-NH2



of 400



1983

Medi-491 5/7/1999 MedImmune, Inc.1984

pazopanib n/a 5/6/2013 Treatment of ovarian cancer.1985

n/a 4/2/2015 Treatment of angiosarcoma1986

PEG-glucocerebrosidase Lysodase 12/9/19921987

PEG-interleukin-2 n/a 2/1/1990 Chiron Corporation1988 pegargiminase n/a 7/21/2014 Treatment of mesothelioma. Polaris Group1989

Peginterferon alfa-2a Pegasys 9/30/19991990

Peginterferon alfa-2a Pegasys 7/13/19981991

pegsitacase Uricase-Peg 20 12/3/2009 EnzymeRx, LLC1992

pegylated arginine deiminase Hepacid 3/26/1999

Parvovirus B19 (recombinant VP1 and VP2; S.frugiperda cells) vaccine

Prevention of transient aplastic crisis in patients with sickle cell anemia.


PEG-b-PLA micelles containing (1) paclitaxel, (2) sirolimus (rapamycin) and (3) tanespimycin (17-AAG)(also known as: triolimus)

Co-D Therapeutics, Inc.

For use as chronic enzyme replacement therapy in patients with Gaucher's disease who are deficient in glucocerebrosidase.

National Institute of Mental Health, NIH

Treatment of primary immunodeficiencies associated with T-cell defects.


Hoffman-La Roche Inc.


Hoffman-La Roche Inc.

Treatment of Lesch-Nyhan syndrome.


Polaris Pharmaceuticals, Inc.


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1993

Pegylated arginine deiminase Melanocid 4/12/19991994

pegylated carboxyhemoglobin n/a 10/21/2010 Sangart, Inc.1995

Sanguinate 1/15/20151996

n/a 4/30/2014 PharmaEssentia1997

n/a 3/16/2015 AERase, Inc.1998

n/a 4/10/2014 Treatment of myelofibrosis1999

n/a 4/11/20142000


n/a 10/25/20132002

n/a 10/1/2014 Treatment of pancreatic cancer

Treatment of invasive malignant melanoma.

Polaris Pharmaceuticals, Inc.

Treatment of acute painful sickling crises in patients with sickle cell disease

pegylated carboxyhemoglobin bovine

Treatment of the comorbidities associated with Sickle Cell Disease

Prolong Pharmaceuticals, LLC

pegylated granulocyte colony stimulating factor

Treatment of patients at risk of developing myelosuppression following a radiological or nuclear incident

pegylated human recombinant arginase I

Treatment of arginase I deficiency (hyperargininemia).

pegylated proline interferon alpha-2b

PharmaEssentia, Corporation

pegylated proline interferon alpha-2b

Treatment of essential thrombocythemia

PharmaEssentia, Corporation

pegylated proline-interferon alpha-2b; PEG-P-IFNa-2b

PharmaEssentia Corporation

PEGylated recombinant anti-Pseudomonas aeruginosa PcrV Fab' antibody

Treatment of cystic fibrosis patients with Pseudomonas aeruginosa lung infections

KaloBios Pharmaceuticals, Inc.

PEGylated recombinant human hyaluronidase PH20

Halozyme Therapeutics, Inc.


of 400



2003n/a 7/18/2016 Treatment of pancreatic cancer

2004pelareorep Reolysin 2/24/2015

2005pelareorep Reolysin(R) 2/10/2015 Treatment of ovarian cancer

2006pelareorep Reolysin 4/15/2015 Treatment of malignant glioma

2007pelareorep Reolysin 5/4/2015 Treatment of gastric cancer

2008pelareorep Reolysin(R) 2/24/2015

2009pelareorep Reolysin(R) 2/11/2015 Treatment of pancreatic cancer

2010

Peldesine n/a 10/5/19932011

pembrolizumab Keytruda 6/16/20152012


pembrolizumab Ketruda 1/14/20162014

pembrolizumab Keytruda 2/17/2016 Treatment of multiple myeloma.2015


Pegylated recombinant human interleukin-10

ARMO BioSciences, Inc.

Treatment of fallopian tube cancer

Oncolytics Biotech, Inc.




Treatment of primary peritoneal cancer




BioCryst Pharmaceuticals, Inc.

Treatment of gastric cancer, including gastroesophageal junction adenocarcinoma

Merck, Sharp & Dohme

Treatment of Hodgkin lymphoma.

Merck, Sharp & Dohme Corp.

Treatment of primary mediastinal B cell lymphoma.



Treatment of nasopharyngeal carcinoma

Merck, Sharp & Dohme Corp., a subsidiary of Merck & Co.


of 400



2016pentagastrin n/a 5/29/2009

2017Pentamidine isethionate n/a 10/29/1984 Aventis Behring L.L.C.

2018

Pneumopent 10/5/1987 Fisons Corporation2019

n/a 1/13/2015 CereNOva, LLC2020

Cylexin 7/18/1997 Cytel Corporation2021

pentetate trisodium 4/12/20042022

pentetrazol n/a 9/9/20152023

pentosan polysulfate sodium n/a 9/16/2011 Treatment of sickle cell disease.2024

pentosan polysulfate sodium n/a 11/21/2008 Treatment of sickle cell disease. TRF Pharma, Inc.

To aid in the diagnosis of medullary thyroid carcinoma

Medical Defense Technologies, LLC

Treatment of Pneumocystis carinii pneumonia.

Pentamidine isethionate (inhalation)

Prevention of Pneumocystis carinii pneumonia in patients at high risk of developing this disease

pentapeptide with sequence Ac-VSRRR-NH2

Treatment of intracerebral hemorrhage

Pentasaccharide ethyl glycoside consisting of one alpha-D-sialylosyl residue as a sodium salt, two beta-D-galactopyranosyl residues, one 2-acetamido-beta-D-glucopyranosyl unit, and one alpha-L-fucopyranosyl unit

Treatment of neonates and infants undergoing cardiopulmonary bypass during surgical repair of congenital heart lesions.

Diethylenetriaminepentaacetate

Treatment of patients with known or suspected internal contamination with plutonium, americium, or curium.

Heyl Chemisch-Pharmazeutische Fabrik GMBH & Co. KG

Treatment of idiopathic hypersomnia.

Balance Therapeutics, Inc.

Vanguard Therapeutics, Inc.


of 400



2025

pentosan polysulfate sodium Lysosan (Tm) 1/5/20152026

Pentostatin Nipent 1/29/1991 SuperGen, Inc.2027



pentoxifylline n/a 6/14/2012 Treatment of Behcet's disease2030

n/a 4/27/2006 Treatment of systemic sclerosis Digna Biotech, S.L.2031

n/a 4/26/2006 Digna Biotech, S.L.2032


n/a 9/15/2010 Rose Pharmaceuticals2034

peptide YY n/a 4/18/2011

Treatment of mucopolysaccharidosis (MPS) type VI

Plexcera Therapeutics, LLC

Treatment of patients with chronic lymphocytic leukemia.


Treatment of peripheral T-cell lymphomas.


Peptide 144 TGF beta-1 inhibitor

Peptide 144 TGF beta-1-inhibitor

Treatment of localized scleroderma

Peptide consisting of L-amino acids with the sequence H-lys-glu-phe-leu-his-pro-ser-lys-val-asp-leu-pro-arg-OH

Soricimed Biopharma, Inc.

Peptide that inhibits mechanosensitive ion channel (MSC) activity

Treatment of Duchenne Muscular Dystrophy (DMD.)




of 400



2035

n/a 2/20/2009 VAXON-Biotech2036

n/a 9/3/20092037

n/a 2/4/2011 Treatment of myasthenia gravis CuraVac Europe SPRL2038

n/a 5/14/20072039

perampanel Fycompa 12/7/2012 Eisai, Inc.2040

peretinoin n/a 9/23/2011

peptide-based vaccine targeting telomerase reverse transcriptase

Treatment of telomerase reverse transcriptase (TERT) positive non-small cell lung cancer in HLA-A*0201 positive patients

peptide-conjugated phosporodiamidate morpholino oligomer (PPMO)

Treatment of Duchenne muscular dystrophy in patients with a deletion, duplication or frame shift mutation correctable by skipping of exon 50 of the dystrophin gene to allow restoration of the reading frame (including mutations within exons 51, 51-53, or 51-55).


peptides mimicking antigen receptors on autoimmune B cells and autoimmune T cells associated with myasthenia gravis

Peptidomimetic analog of hexarelin

Diagnosis of growth hormone deficiency

Aeterna Zentaris GmbH

Treatment of Lennox-Gastaut Syndrome


Kowa Pharmaceutical Europe Co. Ltd.


of 400



2041

Perflubron Liquivent(Tm) 4/26/20012042

perhexiline maleate n/a 6/14/20122043

perifosine n/a 7/9/2010 Treatment of neuroblastoma2044

perillyl alcohol n/a 4/18/2011 Treatment of glioma2045 pertuzumab n/a 6/8/2009 Treatment of ovarian cancer Genentech, Inc.2046

pertuzumab n/a 7/12/2013 Genentech, Inc.2047

pexastimogene devacirepvec n/a 5/6/20132048

n/a 7/5/20122049

PGC-C12E-terlipressin n/a 12/27/20122050

n/a 10/23/2013

Treatment of acute respiratory distress disease (ARDS) in adults

PFC Development/New Alliance Pharmaceutical

Treatment of moderate to severe symptomatic hypertrophic cardiomyopathy

Heart Metabolics, Limited.

Aeterna Zentaris GmbH

NeOnc Technologies, Inc.

Treatment of gastric cancer, including gastroesophageal junction cancer


SillaJen Biotherapeutics, Inc.

PG2 (Astragalus polysaccharides extracted and purified from the dry root of Astragalus membranaceus)


PhytoHealth Corporation

Treatment of ascites due to all etiologies except for cancer

PharmaIN Corporation

phenobarbitol sodium injection

Treatment of hypoxic-ischemic encephalopathy to prevent siezures in neonates



of 400



2051

n/a 3/16/20152052

Phenylacetate n/a 3/6/19982053

Phenylalanine ammonia-lyase Phenylase. Ravpal-Peg 3/8/19952054

Phenylbutyrate n/a 1/19/20002055

phenylephrine n/a 2/14/2002 S.L.A. Pharma2056

phenylephrine n/a 1/31/2012 Treatment of Tetralogy of Fallot2057

n/a 11/2/20102058

n/a 8/23/2016 TG Therapeutics, Inc.2059

n/a 9/22/2008 Treatment of Ewing's sarcoma2060

picibanil n/a 3/17/2011 Richard Smith, M.D.

phenol, 4-[2-(aminomethyl)-4-thiazolyl]-2,6-bis (1,1-dimethyethyl) monohydrochloride



For use as an adjunct to surgery, radiation therapy and chemotherapy for the treatment of patients with primary or recurrent malignant glioma.

Elan Drug Delivery, Inc.

Treatment of hyperphenylalaninemia

BioMarin Pharmaceutical



Treatment of ileal pouch anal anastomosis related fecal incontinence


Phosphatidylinositol 3-Kinase "PI3K" Inhibitor

Treatment of chronic lymphocytic leukemia (CLL)

Semafore Pharmaceuticals

phosphoinositide-3-kinase delta inhibitor


phosphorothioate antisense olignucleotide against EWS-Fli-1

The Cure Our Children Foundation

Treatment of lymphatic malformations


of 400



2061

picibanil n/a 5/15/20092062

Picoplatin n/a 11/2/20052063

pirfenidone n/a 7/31/20142064

pirfenidone n/a 11/19/2013 Genentech, Inc.2065



plasmin (human) n/a 3/30/20092068

plasminogen (human) n/a 3/5/20132069

pleconaril n/a 12/22/2014

Treatment of patients with lymphatic malformations

Royds Pharmaceuticals, Inc.


Poniard Pharmaceuticals


Genoa Pharmaceuticals, Inc.

Treatment of systemic sclerosis (including the associated interstitial lung disease)

plasmid DNA encoding the human cystic fibrosis transmembrane conductance regulator gene complexed with a nonviral cationic lipid based gene transfer agent

Imperial Innovations Limited

Plasmid DNA vector expressing cystic fibrosis transmembrane gene

Copernicus Therapeutics, Inc.

Treatment of acute peripheral arterial occlusion


Treatment of hypoplasminogenemia, or type I plasminogen deficiency

ProMetic BioTherapeutics, Inc

Treatment of symptomatic enteroviral infection in the neonate

AntiVirus Therapeutics, Inc.


of 400



2070Plitidepsin Aplidin 9/30/2004 Treatment of multiple myeloma PharmaMar USA, Inc.

2071polidocanol n/a 2/19/2015 Provensis Ltd

2072

Poloxamer 188 n/a 8/5/1997 CytRx Corporation2073

Poloxamer 188 Florcor 2/22/1990 CytRx Corporation2074

poloxamer 188 n/a 11/8/20132075

poloxamer 188 (purified) n/a 6/27/19892076

Poloxamer 331 Protox 3/21/1991 CytRx Corporation2077

poloxamer-188 NF n/a 1/19/20102078

Poly I: poly C12U Ampligen 12/9/19932079



Treatment of congenital venous malformations

Treatment of vasospasm in subarachnoid hemorrhage patients following surgical repair of a ruptured cerebral aneurysm.

Treatment of severe burns requiring hospitalization.

Treatment of Acute Limb Ischemia

Mast Therapeutics Inc.

Treatment of sickle cell disease (this includes the treatment and prevention of complications of sickle cell disease)

Mast Therapeutics Inc.

Initial therapy of toxoplasmosis in patients with AIDS.


Phrixus Pharmaceuticals, Inc.

Treatment of invasive metastatic melanoma (stage IIb, III, IV).

Hemispherx Biopharma, Inc.

Treatment of chronic fatigue syndrome





of 400



2081

n/a 10/25/20132082

n/a 9/13/2016 Treatment of malaria2083

poly-CD-PEG-camptothecin n/a 5/21/2015 Treatment of ovarian cancer. Cerulean Pharma, Inc.2084

Poly-ICLC Hiltonol 3/17/1997 Oncovir2085

n/a 4/5/2016 TGV-Inhalonix, Inc.2086

n/a 3/17/2015 Treatment of homocystinuria2087

Zurase 9/14/1999 EnzymeRx, LLC

poly(lactide-co-glycolide) carboxylated microparticle

Treatment of acute encephalitis syndrome

Cour Pharmaceutical Development Company, Inc.

poly(lactide-co-glycolide) carboxylated microparticle

Cour Pharmaceutical Development Company, Inc.

Treatment of primary brain tumors.

poly-N,N'-hexamethyleneguanidine-poly-N1,N4-hexamethyleneaminoguanidine

Treatment of pulmonary infections in patients with cystic fibrosis including infections due to pseudomonas aeruginosa,Burkholderia cepacia and other bacteria

polyethylene glycol modified recombinant C-terminal truncate of human cystathionine beta-synthase

Orphan Technologies Limited

Polyethylene glycol-modified uricase

Prophylaxis of hyperuricemia in cancer patients prone to develop tumor lysis syndrome during chemotherapy.


of 400



2088

Zurase 12/21/1998 EnzymeRx, LLC2089

n/a 6/6/2005 EnzymeRx, LLC2090

polyinosinic-polycytidilic acid Poly-Iclc 8/2/2002 Oncovir2091

polyinosinic-polycytidilic acid Poly-Iclc 3/3/2003 Oncovir2092

Hiltonol 11/19/2002 Oncovir2093

Polymeric oxygen n/a 3/25/1992 Treatment of sickle cell anemia. Capmed USA2094

polyphenon E n/a 7/17/2008 Mitsui Norin Co., Ltd2095

Ampligen 7/19/1988 Treatment of AIDS2096

n/a 6/9/2006 Polynoma LLC


Treatment of tumor lysis syndrome in cancer patients undergoing chemotherapy.


Treatment of hyperuricemia in patients with gout refractory to conventional therapy or in whom conventional therapy is contraindicated

As an adjuvant to smallpox vaccination

Treatment of flavivirus infections including those due to West Nile, Japanese encephalitis, dengue, St. Louis encephalitis, yellow fever, Murray valley, and Banzai viruses

polyinosinic-polycytidilic acid (Poly-ICLC)

Treatment for orthopox virus infections


Polyribonucleotide; Polyribo-inosinic/-cyclidylic/-uridylic acid


Polyvalent, shed-antigen melanoma vaccine

Treatment of stage IIb to stage IV melanoma


of 400



2097

pomalidomide n/a 9/21/2010 Celgene Corporation2098

ponatinib Iclusig(R) 3/12/20152099

Neurocell-Pd 12/17/1996 Diacrin/Genzyme LLC2100

Neurocell-Pd 12/17/1996 Diacrin/Genzyme LLC2101

Neurocell-Hd 12/10/1996 Diacrin/Genzyme LLC2102

Neurocell-Hd 12/10/1996 Diacrin/Genzyme LLC

Treatment of persons with myeloproliferative neoplasm-associated myelofibrosis and anemia who are red blood cell tranfusion dependent.

Treatment of gastrointestinal stromal tumors (GIST).

ARIAD Pharmaceuticals, Inc.

Porcine fetal neural dopaminergic cells and/or precursors aseptically prepared and coated with anti-MHC-1 Ab for intracerebral implantation

Treatment of Hoehn and Yahr stage 4 and 5 Parkinson's disease.

Porcine fetal neural dopaminergic cells and/or precursors aseptically prepared for intracerebral implantation.

Treatment of Hoehn and Yahr stage 4 and 5 Parkinson's disease.

Porcine fetal neural gabaergic cells and/or precursors aseptically prepared and coated with anti-MHC-1 Ab for intracerebral implantation


Porcine fetal neural gabaergic cells and/or precursors aseptically prepared for intracerebral implantation for Huntington's disease.



of 400



2103porcine GM1 ganglioside n/a 12/3/2012

2104

N-Graft 6/24/19972105

Porfimer sodium Photofrin 11/15/19892106


Porfiromycin Promycin 3/13/1997 Treatment of cervical cancer.2108

Porfiromycin Promycin 9/19/19952109

Posaconazole Noxafil 10/4/20162110

Posaconazole Posoril 7/16/2004 Treatment of zygomycosis2111

n/a 1/8/20072112

pracinostat n/a 2/27/2014 MEI Pharma Inc.


TRB Chemedica International S.A.

Porcine Sertoli cells aseptically prepared for intracerebral co-implantation with fetal neural tissue

Treatment of Hoehn and Yahr stage four and five Parkinson's disease.

Titan Pharmaceuticals, Inc.

For the photodynamic therapy of patients with transitional cell carcinoma in situ of the urinary bladder.

QLT Phototherapeutics, Inc.

Treatment of cholangiocarcinoma

Concordia Laboratories, Inc.


Treatment of head and neck cancer.




Schering-Plough Corporation

potassium sodium aluminosilicate

For treatment of poisoning by or exposure to cesium.

Castle Creek Pharmaceuticals, LLC

Treatment of acute myeloid leulemia


of 400



2113

pralatrexate n/a 5/3/20102114



pralmorelin hydrochloride n/a 10/18/20122117

pramipexole Mirapex 1/31/20082118

prasugrel hydrochloride Effient 5/26/2015 Treatment of sickle cell disease Eli Lilly2119

Primaquine phosphate n/a 7/23/1993 Sanofi Winthrop, Inc.2120

pritumumab n/a 10/28/2014 Treatment of glioma Nascent Biotech, Inc.2121

pritumumab n/a 4/6/2016 Treatment of pancreatic cancer. Nascent Biotech, Inc.2122

Procarbazine HCl Matulane 8/8/2006 Treatment of malignant glioma

Treatment of advanced or metastatic transitional cell carcinoma of the urinary bladder






As a diagnostic agent for the detection of growth hormone deficiency

Sella Pharmaceuticals, Inc.

Treatment of Tourette's syndrome in pediatric patients

Boehringer-Ingelheim Pharmaceuticals, Inc.

For use in combination with clindamycin hydrochloride in the treatment of Pneumocystis carinii pneumonia associated with AIDS.



of 400



2123n/a 7/23/2015 Treatment of malignant glioma

2124profimer sodium Photofrin(R) 12/2/2011

2125

progesterone n/a 12/22/19942126

prolactin receptor antagonist Prolanta 4/15/2013 Treatment of ovarian cancer Oncolix, Inc.2127

n/a 12/9/20152128

propofol hemisuccinate n/a 8/19/2016 EpaleX Corporation2129

propranolol and etodolac n/a 4/27/2015 Treatment of pancreatic cancer.2130

propranolol and etodolac n/a 7/8/2015 Treatment of malignant glioma.2131

n/a 2/24/20152132

Circulase 6/12/19982133 Protaxel n/a 5/21/2003 Treatment of ovarian cancer Biophysica, Inc.

procaspase-activating compound 1

Vanquish Oncology, Inc.


Concordia Laboratories, Inc.

Establishment and maintenance of pregnancy in women undergoing in vitro fertilization or embryo transfer procedures.


propagermanium and irbesartan

Treatment of focal segmental glomerulosclerosis.

Dimerix Bioscience Ltd.

Treatment of acute repetitive seizures

Vicus Therapeutics, LLC


propranolol hydrochloride and etodolac



Prostaglandin E1 enol ester (AS-013)

Treatment of Fontaine Stage IV chronic critical limb ischemia.

LTT Baio-Pharma Co., Ltd


of 400



2134

Protein C concentrate 6/19/19922135

n/a 9/19/2016 Fate Therapeutics2136

n/a 9/1/2015 TxCell SA2137

purified bovine type collagen n/a 4/27/2009 ImmuneWorks, Inc.2138

Immudyn 9/22/19972139

Purified type II collagen Colloral 2/9/1995 AutoImmune, Inc.2140

Imt504 11/24/2014

Protein C Concentrate (Human) Vapor Heated, Immuno

For replacement therapy in patients with congenital or acquired protein C deficiency for the prevention and treatment of warfarin-induced skin necrosis during oral anticoagulation.

Immuno Clinical Research Corp.

ProTmune (ex vivo Programmed Mobilized Peripheral Blood)

Prevention of graft-versus-host disease in patients undergoing allogenic hematopoietic cell transplantation

purified autologous type 1 regulatory T lymphocytes specific for human type II collagen

Treatment of chronic non-infectious uveitis


Purified extract of Pseudomonas aeruginosa

Treatment of immune thrombocytopenia purpura where it is required to increase platelet counts.

Able Laboratories, Inc.


PyNTTTTGT class of oligodeoxynucleotide with a 24-base single chain composed of nucleotide sequence 5'TCATCATTTTGTCATTTTGTCATT 3'

Treatment of rabies virus infections

Mid-Atlantic BioTherapeutics, Inc.


of 400



2141

pyridoxine; vitamin B6 n/a 3/3/20112142

pyrimethamine n/a 8/16/2011 ExSAR Corporation2143

Pyruvate n/a 2/21/2001 Cellular Sciences, Inc2144

pyrvinium n/a 1/5/20152145

quinacrine n/a 9/28/20122146

quinine sulfate n/a 12/2/20082147

R-(-)-gossypol n/a 10/24/20062148

n/a 9/10/2009 Treatment of gastric carcinoids Trio Medicines Ltd.2149

n/a 11/28/20082150

rAAV2-CB-hRPE65 n/a 2/11/2005

Treatment of pyridoxine dependent seizures.


Treatment of GM-2 gangliosidoses (Tay-Sachs disease and Sandhoff disease).

Treatment of interstitial lung disease.


StemSynergy Therapeutics, Inc.


Cleveland BioLabs, Inc & Incuron, LLC Joint Ventur

Treatment of malaria excluding Plasmodium faliparum

Zydus Pharmaceuticals, Inc.


Ascenta Therapeutics, Inc.

R-1-[2,3-dihydro-2-oxo-1-pivaloylmethyl-5-(2-pyridyl)-1 H -1,4-benzodiazepine -3-yl]-3-(3-methylaminophenyl)urea

R-4-amino-3-(4-chlorophenyl)butanoic acid

Treatment of the behavorial abnormalities associated with fragile X syndrome

Seaside Therapeutics, Inc.

Treatment of type II Leber's Congential Amaurosis

Applied Genetic Technologies Corp.


of 400



2151

Thymoglobulin 9/26/20062152

Galiomedix(Tm) 12/31/2013 RadioMedix, Inc.2153

raloxifene hydrochloride Evista 8/20/20102154

ramucirumab n/a 11/4/2011 Eli Lilly and Company2155

ranagengliotucel-L Glionix(Tm) 5/29/2009 Treatment of astrocytic tumors NovaRx Corporation2156

ranprinase Onconase 1/25/2007 Alfacell Corporation2157

Rapamycin n/a 3/20/2007 OncoImmune, Inc.2158

rapamycin n/a 2/24/2016 DSLP2159

rapamycin n/a 10/20/2016 Lam Therapeutics2160

n/a 2/6/20142161

n/a 6/19/2014 Treatment of pancreatic cancer.

Rabbit anti-human thymocyte globulin (rATG)

Induction treatment to prevent rejection and to minimize maintenance immunosupression in pediatric liver transplant recipients

Children's Hospital of Pittsburgh

radiolabeled somastatin analog

Diagnostic for the management of neuroendocrine tumors

Treatment of hereditary hemorrhagic telangiectasia

Consejo Superior de Investigaciones Cientificas



Treatment of tuberous sclerosis complex

Treatment of facial angiofibromas (FA) associated with tuberous sclerosis complex (TSC).

Treatment of pulmonary arterial hypertention

Re188 P2045 somatostatin analog


Andarix Pharmaceuticals

Re188 P2045 somatostatin peptide analogue

Andarix Pharmaceuticals, Inc.


of 400



2162recilisib sodium Ex-Rad(R) 6/1/2012

2163recilisib sodium Ex-Rad(R) 9/4/2012

2164

n/a 4/30/20142165

n/a 4/29/2014 Abeona Therapeutics2166

n/a 3/3/2015 Pfizer, Inc.2167

n/a 3/25/20132168

n/a 5/11/20092169

Raav-Aat 1/27/20032170

n/a 8/25/2009 Neurologix, Inc.

Prevention of acute radiation syndrome

Onconova Therapeutics, Inc.



Recombinant AAV9 expressing human alpha-N-acetylglucosaminidase

Mucopolysaccharidosis III-B (Sanfilippo Syndrome Type B)

Abeona Therapeutics LLC

recombinant AAV9 expressing human sulfoglucosamine sulfohydrolase

Treatment of mucopolysaccharidosis type III-A (Sanfilippo Syndrome Type A)

recombinant activated Factor X variant

Treatment of intracerebral hemorrhage

recombinant adeno- associated virus vector AAV2/rh8 expressing human B-hexosaminidase A and B subunits

For the treatment of Sandhoff disease

Nat'l Tay-Sachs & Allied Diseases Association

Recombinant adeno-associated virus (serotype 2) (rAAV2) gene transfer agent expressing RPE65

Treatment of Leber's congential amaurosis

AmpliPhi Biosciences Corporation

recombinant adeno-associated virus alpha 1-antitrypsin vector

Treatment of alpha1-antitrypsin deficiency


recombinant adeno-associated virus encoded gene for X-linked mammalian inhibitor of apoptosis protein (XIAP)



of 400



2171

n/a 6/24/20082172

n/a 9/28/20162173

n/a 10/29/20152174

n/a 12/29/20152175

n/a 6/16/2015

Recombinant adeno-associated virus retinal pigment epithelium gene vector AAV2-hRPE65v2

Treatment of Leber congenital amaurosis due to RPE65 mutations.


recombinant adeno-associated virus serotype 8 vector encoding human glucose-6-phosphatase-alpha (G6Pase or G6PC)

Treatment of glycogen storage disease type Ia (von Gierke Disease)


recombinant adeno-associated virus serotype 9 vector containing the transgene UBE3A encoding for ubiquitin protein ligase E3A/E6-AP

Treatment of Angelman Syndrome.

Agilis Biotherapeutics, LLC

recombinant adeno-associated virus serotype AAV8 vector encoding human ornithine transcarbamylase

Treatment of ornithine transcarbamylase deficiency


recombinant adeno-associated virus serotype rhesus 74 (rh74) expressing the human CT GalNac transferase (GALGT2) gene, also called the Sda or Cad GAlNac transferase or b4Galnt2, under control of the muscle creatine kinase (MCK) promoter


Nationwide Children's Hospital


of 400



2176

n/a 9/19/20162177

n/a 11/16/20152178

n/a 2/4/20112179

n/a 9/1/20162180

n/a 9/1/2016

recombinant adeno-associated virus serotype rhesus 74 expressing the human dysferin gene (AAVrh74.MHCK7.DYSF.DV)

Treatment of Limb Girdle Muscular Dystrophy Type 2B

Nationwide Children's Hospital

recombinant adeno-associated virus vector expressing the cyclic nucleotide gated channel alpha subunit (CNGA3)

Treatment of achromatopsia caused by mutations in the CNGA3 gene


recombinant adeno-associated virus vector expressing the cyclic nucleotide gated channel beta subunit (rAAV-CNGB3)

Treatment of achromatopsia caused by mutations in the CNGB3 gene.

Applied Genetic Technologies Corporation

recombinant adeno-associated virus vector serotype 9 expressing human iduronate-2-sulfatase

Treatment of mucopolysaccharidosis II, also called Hunter syndrome A.

Research Institute at Nationwide Children's Hospital

recombinant adeno-associated virus vector serotype 9 expressing human N-Sulfoglucosamine Sulfohydrolase

Treatment of mucopolysaccharidosis type III A, also called Sanfilippo syndrome A

Research Institute at Nationwide Children's Hospital


of 400



2181

n/a 3/25/2013 Treatment of Tay-Sachs disease2182

n/a 8/20/2009 Treatment of Hodgkin lymphoma Affimed GmbH2183

n/a 4/26/2006 Savara Inc.2184

Cethrin 11/18/20052185

n/a 7/29/2008 Baxalta US Inc.2186

n/a 7/29/2008 Baxalta US Inc.2187

recombinant DNA plasmid n/a 1/31/2014 Scancell Ltd.2188

recombinant elafin n/a 3/18/2013 Proteo Biotech AG

recombinant adenovirus vector AAV2/rh8 expressing human B-hexosaminidase A & B subunits

Na't Tay-Sachs & Allied Diseases Association

Recombinant antibody construct against human CD30 and CD16A

Recombinant coagulation factor VIIa

Treatment of diffuse alveolar hemorrhage

recombinant deriative of C3 transferase


Vertex Pharmaceuticals, Inc.

Recombinant disintegrin and metalloprotease with thrombospondin type 1 motifs

Prevention of thrombotic thrombocytopenic purpura including its congential, acquired idiopathic and secondary forms.

Recombinant disintegrin and metalloprotease with thrombospondin type 1 motifs

Treatment of thrombotic thrombocytopenic purpura including its congential, acquired idiopathic, and secondary forms.

Treatment of stage IIb, IIc, III and IV melanoma.

Prevention of inflammatory complications of transthoracic esophagectomy


of 400



2189

n/a 8/18/2005 Henogen S.A.2190

Valortim 2/16/2006 Treatment of anthrax infection PharmAthene, Inc.2191

Recombinant Fusion Protein n/a 7/24/2012 Apogenix GmbH2192

n/a 10/7/20152193


n/a 3/11/2013 Treatment of B-thalassemia Celgene Corporation

Recombinant Epstein-Barr virus gp350 glycoprotein vaccine

Prevention of post-transplantation lymphoproliferative disorders in pediatric recipients of solid-organ transplantation

Recombinant fully human monoclonal antibody to anthrax protective antigen

Treatment of Myelodysplastic Syndrome

recombinant fusion protein comprising exenatide and XTEN

Treatment of short bowel syndrome.

NAIA Pharmaceuticals, Inc.

recombinant fusion protein consisiting of a modified form of extracellular domain of human Activin receptor IIB


recombinant fusion protein consisting of a modified form of the extracellular domain of human activin receptor IIB (ActRIIB) linked to a human IgG1 Fc domain


of 400



2195

n/a 5/6/2013 CSL Behring2196

n/a 3/19/20012197

Proxinium 1/28/2005 Viventia Biotech, Inc.2198

n/a 10/13/2009 Apogenix GmbH2199

n/a 8/20/2010 Treatment of Pompe disease.2200

n/a 11/9/2016 Genexine, Inc.2201

Plexcerase(Tm) 12/24/2013 Treatment of Faber disease2202

n/a 5/13/2015 Treatment of hypophosphatasia. AM-Pharma BV

recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP)

Treatment of congenital factor VII deficiency which includes treatment and prophylaxis of bleeding episodes in patients with congenital factor VII deficiency

Recombinant fusion protein of Mycobacterium bovis BCG Hsp65 and HPV16 E7

Treatment of recurrent respiratory papillomatosis (RRP)

StressGen Biotechnologies, Inc. is now Nventa

recombinant fusion protein with a truncated form of the cytotoxic protein Pseudomonas exotoxin

Treatment of Ep-CAM-positive squamous cell carcinoma of the head and neck

Recombinant fusion protein-extracellular portion of CD95 fused to the Fc part of human IgG1


recombinant glycosylated independent lysosomal targeting (GILT) tagged human acid alpha glucosidase


recombinant growth hormone fused to hyFc

Treatment of growth hormone deficiency.

recombinant human acid ceramidase

Enzyvant Sciences Ltd.

recombinant human alkaline phosphatase


of 400



2203

n/a 4/28/20052204

n/a 11/20/2001 Treatment of cystic fibrosis AiroMedica LLC2205

n/a 3/6/1998 Treatment of cystic fibrosis.2206

n/a 8/28/2001 AiroMedica LLC2207

n/a 2/22/2001 Treatment of myasthenia gravis2208

n/a 11/19/2013 Treatment of Pompe Disease2209

n/a 2/2/2006 Chiesi USA, Inc.2210

n/a 4/15/20132211

n/a 7/24/2012 Pfizer, Inc.

Recombinant human alpha 1-antitrypsin


Arriva Pharmaceuticals, Inc.

recombinant human alpha 1-antitrypsin (rAAT)

recombinant human alpha-1 antitrypsin

PPL Therapeutics (Scotland) Limited

recombinant human alpha-1 antitrypsin (rAAT)

To delay progression of chronic obstructive pulmonary disease resulting from AAT deficiency-mediated emphysema and bronchiectasis

Recombinant Human Alpha-Fetoprotein (rhAFP)

Alpha Cancer Technologies, Inc.

recombinant human alpha-glucosidase conjugated with synthetic bis-mannose-6-phosphate-Man6 glycan

Genzyme, a Sanofi Company

Recombinant human alpha-mannosidase

Treatment of alpha-mannosidosis

recombinant human alpha-N-acetylglucosaminidase

Treatment of mucopolysaccharidosis IIIB (Sanfilippo B syndrome)


recombinant human anti-GDF-8 monoclonal antibody



of 400



2212

n/a 4/6/2000 AT III LLC2213

n/a 2/16/20122214

recombinant human biglycan n/a 7/13/20162215

n/a 6/9/2006 Pharming Group N.V.2216

n/a 6/9/20062217

n/a 2/23/1999 Pharming Group N.V.2218

n/a 6/9/2015 OncoImmune, Inc.2219

n/a 8/30/1990 Genentech, Inc.2220

n/a 6/8/2016 Herantis Pharma Plc

Recombinant human antithrombin III

Treatment of antithrombin III dependent heparin resistance requiring anticoagulation.

recombinant human beta-glucuronidase

Treatment of mucopolysaccharidosis VII (MPS VII, Sly Syndrome)



Tivorsan Pharmaceuticals, Inc.

Recombinant human C1 inhibitor

Prevention and/or treatment of delayed graft function after solid organ transplantation

Recombinant human C1 inhibitor

Treatment of capillary leakage syndrome

Pharming Technologies B.V.

Recombinant human C1-esterase inhibitor

Prophylactic treatment of angioedema caused by hereditary or acquired C1-esterase inhibitor deficiency.

recombinant human CD24FcIg (humanized fusion protein consisting of the extracellular domain of CD24 linked to IgG1 Fc domain

Prevention of graft-versus-host disease

Recombinant human CD4 immunoglobulin G

Treatment of AIDS resulting from infection with HIV-1.

recombinant human cerebral dopamine neurotrophic factor



of 400



2221

n/a 7/13/19982222

n/a 3/17/20142223

n/a 8/18/2014 SciVac Ltd.2224

n/a 8/18/2014 SciVac Ltd.2225



n/a 5/26/2011 Treatment of mutliple myeloma2228

n/a 11/30/2012 Pfizer, Inc.2229

n/a 10/4/2007

Recombinant human Clara Cell 10kDa protein

Prevention of neonatal bronchopulmonary dysplasia in premature neonates with respiratory distress syndrome.

Therabron Therapeutics, Inc.

recombinant human collagen alpha-1 (VII) chain homo-trimer (rC7)

Treatment of dystrophic epidermolysis bullosa


recombinant human deoxyribonuclease I

Treatment of graft-vs-host disease

recombinant human deoxyribonuclease I (DNase I)

Prevention of graft-vs-host disease

recombinant human endostatin protein


Recombinant human endostatin protein


recombinant human erythropoietin (rHuEPO)

XTL Biopharmaceuticals, Ltd

Recombinant Human Factor VIIa Variant

Routine prophylaxis to prevent bleeding episodes in patients with hemophilia A and B patients with inhibitors

Recombinant human fibrinogen

Treatment of bleeding in patients deficient in fibrinogen

Pharming Technologies B.V.


of 400



2230

n/a 1/27/2015 TargaZyme, Inc.2231

Galaczym 12/12/2011 ACE BioSciences A/S2232

Recombinant human gelsolin n/a 3/6/19952233

Recombinant human gelsolin n/a 1/12/19942234

n/a 3/22/20102235

n/a 10/31/2012 Savara Inc.2236

n/a 12/3/2012 Jade Therapeutics LLC2237

Tbd 9/20/2000

recombinant human fucosyltransferase VI [ FTVI ] + GDP-fucose

To increase the activity of regulatory T-cells (Tregs) used in the prevention of graft versus host disease in patients undergoing hematopoietic stem cell transplantation

recombinant human galactocerebrosidase (rhGALC);

Treatment of globoid cell leukodystrophy (Krabbe Disease)

Treatment of acute and chronic respiratory symptoms of bronchiectasis.

BioAgeis, Therapeutics, Inc.

Treatment of the respiratory symptoms of cystic fibrosis.

BioAegis Therapeutics, Inc.

Recombinant human glutamic acid decarboxylase 65KDa isoform

Treatment of Type I diabetes with residual beta cell function

Diamyd Therapeutics AB

recombinant human GM-CSF, molgramostim

Treatment of pulmonary alveolar proteinosis

recombinant human gowth hormone in an ocular delivery system

Treatment of persistent corneal epithelial defects

Recombinant human highly phosphorylated acid alpha-glucosidase

For enzyme replacement therapy in patients with all subtypes of glycogen storage disease type II (GSDII, Pompe Disease)

Novazyme Pharmaceuticals, Inc.


of 400



2238

n/a 4/11/20012239

n/a 4/22/2015 aTyr Pharma, Inc.2240

Oncohist 10/20/20082241

n/a 12/14/20092242

Pv802 2/16/2000 GroPep Pty Ltd.2243

n/a 6/15/1999 Insmed, Inc.2244

n/a 10/20/19972245

Hemamax 8/22/2016 Neumedicines, Inc.2246

n/a 10/4/2005 Zymo Genetics, Inc

Recombinant human highly phosphorylated alpha-L-iduronidase (rhHP-IDUA)

Enzyme replacement therapy in patients with all subtypes of Mucopolysaccharidosis I.

Novazyme Pharmaceuticals, Inc.

recombinant human histidyl tRNA synthetase

Treatment of facioscapulohumeral muscular dystrophy

recombinant human histone H1.3; recombinant human N-bis-met-histone H1.3


Xenetic Biosciences Plc

recombinant human IgG1 monoclonal antibody

Treatment of X-linked hypophosphatemia (formerly known as vitamin D-resistant rickets)


Recombinant human insulin-like growth factor-I

Treatment of short-bowel syndrome as a result of resection of the small bowel or as a result of congenital dysfunction of the intestines.

Recombinant human insulin-like growth factor-I/insulin-like growth factor binding protein-3

Treatment of major burns that require hospitalization.

Recombinant human interleukin-12


Genetics Institute, Inc.

recombinant human interleukin-12


Recombinant Human Interleukin-21 (rIL-21)

Treatment of stage II (T4), III or IV malignant melanoma.


of 400



2247

n/a 12/20/19992248

n/a 9/2/20102249

Cholestrase 7/14/20052250

n/a 1/23/2006 ThromboGenics Ltd2251

Mubodina(R) 6/7/2011 Adienne S.A2252

Mubodina 2/4/2009 Adienne S.A.2253

n/a 2/4/2009 Adienne S.A.2254

n/a 6/18/2012

Recombinant human keratinocyte growth factor

Reducing the incidence and severity of radiation-induced xerostomia.


recombinant human lecithin:cholesterol acyltransferase (rhLCAT)

Treatment of LCAT deficiency syndromes

AlphaCore Pharma, LLC

Recombinant human lysosomal acid lipase or cholesteryl ester hydrolase

Treatment of lipase deficiencies, including Wolman Disease and cholesteryl ester storage disease

Lysosomal Acid Lipase, LLC

Recombinant human microplasmin

Treatment of peripheral arterial occlusion

recombinant human minibody against complement component

Treatment of atypical hemolytic uremic syndrome associated with an inherited abnormality of the complement system.

recombinant human minibody against complement component C5

Treatment of primary membranoproliferative glomerulonephritis

recombinant human minibody against complement component C5 fused with RGD-motif

Prevention of ischemia/reperfusion injury associated with solid organ transplantation.

recombinant human monoclonal antibody against activin receptors type II

Treatment of inclusion body myositis



of 400



2255

n/a 10/6/20162256

n/a 8/19/20142257

Mycograb 9/16/2002 Treatment of invasive candidiasis2258


n/a 10/25/2013 Treatment of multiple myeloma Patrys Ltd.2260

n/a 3/5/20132261

n/a 8/8/2013 Dompe s.p.a.2262

n/a 4/16/1999 Genentech, Inc.

Recombinant human monoclonal antibody against human complement component C5a

Treatment of acute graft versus host disease


recombinant human monoclonal antibody of the IgG1 kappa class against human macrophage colony-stimulating factor

Treatment of pigmented villonodular synovitis, including giant cell tumor of the tendon sheath


recombinant human monoclonal antibody to hsp90


recombinant human monoclonal IgG1 antibody against programmed death ligand-1 (anti-PD-L1)

Treatment of merkel cell carcinoma.

recombinant human monoclonal IgM antibody targeting glucose regulated protein 78

recombinant human Naglu- insulin-like growth factor II

Treatment of mucopolysaccharidosis type IIIB (Sanfilippo syndrome type B)


recombinant human nerve growth factor


Recombinant human nerve growth factor

Treatment of HIV-associated sensory neuropathy.


of 400



2263n/a 6/23/2014 Dompe s.p.a.

2264n/a 12/9/2003 Treatment of cystic fibrosis Dyax Corporation

2265n/a 8/26/2014 Treatment of myelofibrosis Promedior, Inc.

2266

n/a 2/17/2012 Promedior, Inc.2267

n/a 2/1/20072268

Porphozyme 9/9/2002 Zymenex A/S2269

n/a 7/11/2002 Zymenex A/S2270

n/a 12/10/20082271

n/a 1/13/20162272

n/a 3/22/2010 SuppreMol GmbH2273

n/a 6/23/2014

recombinant human nerve growth factor

Treatment of neurotrophic keratitis

recombinant human neutrophil inhibitor (hNE)

recombinant human Pentraxin-2

recombinant human Pentraxin-2; recombinant human Serum Amyloid P


Recombinant human platelet derived growth factor BB

Treatment of osteonecrosis of the jaws


recombinant human porphobilinogen deaminase

Treatment of acute intermittent porphyria attacks

recombinant human porphobilinogen deaminase, erythropoetic form

Treatment of acute intermittent porphyria preventing attacks

recombinant human proinsulin (Including rhPI-Methionine)


ProRetina Therapeutics, S.L.

recombinant human serum albumin human growth hormone


TEVA Branded Pharmaceutical Products R&D, Inc.

Recombinant Human soluble Fc-gamma Receptor IIb


recombinant human surfactant protein D


Airway Therapeutics LLC


of 400



2274


n/a 4/3/20092276

n/a 6/18/20082277

n/a 6/7/2010 NeuroNova AB2278

n/a 2/11/20152279

n/a 7/16/2015 Treatment of gastric cancer Gilead Sciences, Inc.2280

n/a 1/22/2015 AbbVie, Inc.2281

n/a 4/12/2013 Treatment of sickle cell disease

Recombinant human thrombopoietin

For use in accelerating platelet recovery in patients undergoing hematopoietic stem cell transplantation.

recombinant human type I pancreatic elastase

Prevention of arteriovenous fistula and arteriovenous graft failure in patients with chronic kidney disease (CKD) who are receiving hemodialysis or preparing for hemodialysis

Proteon Therapeutics, Inc.

recombinant human type VII collagen

Treatment of hereditary dystrophic epidermolysis bullosa (DEB)

David T. Woodley, MD and Mei Chen, MD

recombinant human vascular endothelial growth factor


recombinant humanized anti-interleukin 13 (IL-13) monoclonal antibody


Receptos Services, LLC

recombinant humanized anti-matrix metalloprotein 9 (MMP9) monoclonal antibody IgG4

recombinant humanized anti-tau antibody


recombinant humanized IgG1k monoclonal antibody to human invariant T cell receptor (iTCR)

NKT Therapeutics, Inc.


of 400



2282

n/a 1/11/20162283

n/a 3/22/1999 Biogen, Inc.2284

n/a 3/22/1999 Biogen, Inc.2285

n/a 10/14/1998 Biogen, Inc.2286

n/a 2/3/1998 Biogen, Inc.2287

n/a 2/18/1998 Biogen, Inc.2288


n/a 4/18/2011

recombinant humanized IgG4 monoclonal antibody that binds human colony stimulating factor 1 receptor

Treatment of pigmented villonodular synovitis and tenosynovial giant cell tumor

Five Prime Therapeutics, Inc.

Recombinant humanized MAb 5c8

Prevention of rejection of solid organ transplants.


Prevention of rejection of pancreatic islet cell transplants.


Prevention and treatment of Factor VIII/Factor IX inhibitors in patients with hemophilia A or B.

Recombinant humanized monclonal antibody 5c8


Recombinant humanized monoclonal antibody 5c8

Treatment of systemic lupus erythematosus.

recombinant humanized monoclonal antibody of the immunoglobulin G1 subclass directed against colony stimulating factor-1 receptor expressed on macrophages

Treatment of pigmented villonodular synovitis and tenosynovial giant cell tumor

recombinant IgA protease of bacterium Heamophilus influenzae

Treatment of immunoglobulin A nephropathy (IgAN, Berger's disease).

Shire Human Genetics Therapies


of 400



2290

n/a 2/11/20022291

n/a 2/11/20022292

n/a 11/23/2010 Dermadis SA2293

n/a 5/19/2014 Ocugen, Inc.2294

n/a 11/28/1994 Amgen, Inc.2295

n/a 2/10/2015 Treatment of AL amyloidosis2296

n/a 7/14/2015 Pfizer, Inc.

Recombinant immunotoxin combining the functional components of antibody against mesothelin and the enzymatic activity of a pseudomonas exotoxin

Treatment of epithelial ovarian cancer


Recombinant immunotoxin combining the functional components of antibody against mesothelin and the enzymatic activity of a pseudomonas exotoxin



recombinant kallikrein inhibitor

Treatment of Netherton Syndrome.

recombinant lens epithelium derived growth factor 1-326


Recombinant methionyl brain-derived neurotrophic factor


recombinant monoclonal antibody to human serum amyloid P component

Glaxo Group Limited, England d/b/a GlaxoSmithKline

recombinant multimerized human IgG1 Fc

Treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).


of 400



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n/a 12/8/2014 ARCA Biopharma, Inc.2298

n/a 11/17/20142299

n/a 1/6/2016 Immune Design Corp.2300

Tauferon 1/25/2005 PEPGEN Corporation2301

n/a 3/29/2006 Y's Therapeutics, Inc.2302

n/a 7/26/2007 Y's Therapeutics, Inc.2303

n/a 5/10/2016 Akari Therapeutics Plc2304

n/a 4/12/1999 Schering Corporation2305

n/a 11/15/1993 Genetic Therapy, Inc.

recombinant nematode anticoagulant protein c2 (rNAPc2)

Treatment of viral hemorrhagic fever post-exposure to Ebola virus (treatment of Ebola)

recombinant neuroglobin (rNgb) containing mutations H64Q/C46G/C55S/C120S

Treatment of patients with carbon monoxide poisoning

University of Pittsburgh

recombinant NY-ESO-1 protein mixed with glucopyranosyl lipid A


recombinant ovine interferon tau

Treatment of pediatric multiple sclerosis

Recombinant P-Selectin glycoprotein ligand

Prevention of delayed graft function in renal transplant patients

Recombinant P-selectin glycoprotein ligand-immunoglobulin Ig

Prevention of ischemia reperfusion injury in all solid organ transplants

Recombinant protein inhibitor of complement factor 5

Treatment of Guillain-Barre Syndrome.

Recombinant replication deficient adenovirus vector carrying human p53 gene

Treatment of primary ovarian cancer.

Recombinant retroviral vector - glucocerebrosidase

For use as enzyme replacement therapy for patients with types I, II, or III Gaucher disease.


of 400



2306

n/a 3/29/1991 Treatment of cystic fibrosis. Amgen, Inc.2307


n/a 5/2/20032309

n/a 12/13/20102310

n/a 6/24/2005 Treatment of cystic fibrosis Aerovance, Inc.2311

Recombinant urate oxidase n/a 10/11/20002312

n/a 6/8/2016

Recombinant secretory leucocyte protease inhibitor

Recombinant soluble human CD4 (rCD4)

Treatment of AIDS in patients infected with HIV virus.

Recombinant T-cell receptor ligand

Treatment of multiple sclerosis patients who are both HLA-DR2 positive and autoreactive to myelin oligodendrocyte glycoprotein residues 35-55

Artielle ImmunoTherapeutics, Inc.

recombinant thymidine phosphorylase encapsulated with autologous erythrocytes

Treatment of mitochondrial neurogastrointestinal encephalomyopathydue to thymidine phosphorylase deficiency.

St. George's University of London

Recombinant truncated SPINT2 protease inhibitor

Prophylaxis of chemotherapy-induced hyperuricemia.

Sanofi-Synthelabo Research

recombinant, adeno-associated virus serotype 2 vector carrying linear single-stranded AADC mRNA cDNA

Treatment of aromatic L-amino acid decarboxylase deficiency.

Agilis Biotherapeutics, LLC


of 400



2313

n/a 7/25/2016 Treatment of Friedreich's Ataxia2314

n/a 8/25/20162315

n/a 6/29/20162316


Reduced L-glutathione Cachexon 2/14/1994

recombinant, adeno-associated virus serotype 5 vector, containing the transgene, which encodes for the human protein, frataxin

Agilis Biotherapeuties, LLC

recombinant, fully-human, IgG4 immunoglobulin with antigen-binding specificity for human vascular adhesion protein-1 (VAP-1)

Treatment of primary sclerosing cholangitis.


recombinant, glycoenfineered humanized IgG1 kappa monoclonal antibody directed against Fibroblast Growth Factor Receptor 2b

Treatment of gastric cancer including cancer of the gastroesophageal junction.

Five Prime Therapeutics, Inc.

recombinant, non-pathogenic poliovirus:rhinovirus chimera that consists of the genome of the live attenuated poliovirus serotype 1 vaccine with its cognate IRES element replaced with that of HRV2

Darell D. Bigner, MD, PhD

Treatment of AIDS-associated cachexia.

Telluride Pharmaceutical Corporation


of 400



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refanalin n/a 5/25/20102319

regorafenib Stivarga 6/4/20152320

REMUNE HIV 1 n/a 2/14/20142321

reparixin n/a 9/25/2012 Dompe S.p.A.2322

reparixin n/a 1/27/2003 Dompe S.p.A.2323

Advexin 1/27/20032324

n/a 5/3/2013 MeiraGTx, LLC

To improve renal function and prevent delayed graft function following renal transplantation

Angion Biomedica Corporation



Treatment of pediatric HIV/AIDS (age through 16 years)

Immune Response BioPharma, Inc.

Prevention of graft loss in pancreatic islet transplantation

Prevention of delayed graft function in solid organ transplant

Replication defective recombinant adenovirus serotype 5 vector carrying the p53 gene in its E1 deleted region

Treatment of head and neck cancer

Introgen Therapeutics, Inc.

replication-deficient recombinant serotype 2 adeno-associated viral vector containing hAQP1 cDNA

Treatment of symptoms of Grade 2 and Grade 3 late xerostomia from parotid gland hypofunction caused by radiotherapy for cancer of the oral cavity.


of 400



2325

3/2/2010 Aduro BioTech, Inc.2326

4/30/2010 Aduro BioTech, Inc.2327

Gvax Pancreas 3/1/2010 Treatment of pancreatic cancer. Aduro BioTech, Inc.2328

H.P. Acthar Gel 6/28/20132329

resiniferatoxin n/a 5/13/20032330

reslizumab Cinquil 1/12/20112331

reslizumab n/a 12/19/2007 Teva Respiratory, LLC2332

resminostat n/a 6/29/2011 4SC AG2333

resminostat n/a 9/16/2011 4SC AG

Replication-incompetent GM-CSF-expressing gene-modified allogeneic acute myeloid leukemia cancer cell lines

Gvax Acute Myeloid Leukemia


Replication-incompetent GM-CSF-expressing gene-modified allogeneic chronic myeloid leukemia cancer cell lines

Gvax Chronic Myeloid Leukemia


Replication-incompetent GM-CSF-expressing gene-modified allogeneic pancreatic cancer cell lines

repository corticortropin injection


Questor Pharmaceuticals, Inc.

Treatment of intractable pain at end-stage disease

Sorrento Theraeputics, Inc.

Treatment of hypereosinophilic syndrome

Teva Pharmaceuticals, Inc.

Treatment of children with eosinophilic esophagitis


Treatment of Hodgkin's lymphoma.


of 400



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Hypermune Rsv 9/27/1990 MedImmune, Inc.2335

Retinol palmitate n/a 8/8/20162336

n/a 4/29/20022337

n/a 3/26/2010 Treatment of malaria DesignMedix2338

Revimmune n/a 2/18/20112339

Reviparin sodium Clivarine 6/18/2001 Abbott2340

Reviparin sodium Clivarine 6/18/2001 Abbott2341

revusiran n/a 5/18/20152342

rh-microplasmin, ocriplasmin Jetrea 3/16/2004 ThromboGenics Inc.

Respiratory Syncytial Virus Immune Globulin (human)

Treatment of respiratory syncytial virus lower respiratory tract infections in hospitalized infants and young children.

Prevention of bronchopulmonary dysplasia.

Phillipp Heinrich Novak, DVM, MSc

retroviral gamma-c cDNA containing vector

Treatment of X linked severe combined immune deficiency disease

AVAX technologies, Inc.

Reversal agent linked to chloroquine-like moiety

Treatment of autoimmune hemolytic anemia.

Accentia Biopharmaceuticals

Treatment of deep vein thrombosis which may lead to pulmonary embolism in pediatric patients

Long-term treatment of acute deep vein trombosis with or without pulmonary embolism in pregnant patients

Treatment of transthyretin amyloidosis

Alnylam Pharmaceuticals, Inc.

Adjunct to surgery in cases of pediatric vitrectomy


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rhIGF-I/rhIGFBP-3 Somatokine 12/9/2003 Insmed, Inc.2344

ribavirin Virazole 4/12/19912345

ribavirin elaidate n/a 9/2/20112346

Ribocross 11/8/20162347

ricin vaccine Rivax(R) 1/7/2011 Prevention of ricin intoxication. Soligenix, Inc.2348

Rifabutin n/a 12/18/1989 Pfizer Inc.2349

Rifalazil n/a 4/13/19992350

Rifapentine Priftin 6/9/1995

Treatment of extreme insulin resistance syndromes (type A, Rabson-Mendenhall syndrome, Leprechaunism, Type B syndrome)

Treatment of hemorrhagic fever with renal syndrome

Valeant Pharmaceuticals International

Treatment of follicular, medullary, and anaplastic thyroid carcinoma and metastatic or locally advanced papillary thyroid cancer

Translational Therapeutics, Inc.

riboflavin-vitamin E-TPGS topical solution

Treatment of keratoconus in patients undergoing crosslinking procedure

Institute of Refractive & Ophthalmic Surgery

Treatment of disseminated Mycobacterium avium complex disease.


PathoGenesis Corporation

Treatment of Mycobacterium avium complex in patients with AIDS.

Hoechst Marion Roussel , Inc.


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2351

Rifapentine Priftin 3/12/19962352

rigosertib n/a 3/16/2012 Treatment of ovarian cancer2353

rigosertib n/a 3/18/2011 Treatment of pancreatic cancer.2354

rigosertib n/a 9/3/20092355

RII retinamide n/a 5/6/19932356

rilonacept Arcalyst 1/9/20132357

rilotumumab n/a 6/18/2012 Amgen, Inc.2358

riluzole n/a 2/23/20162359

Riluzole Rilutek 10/15/19962360

riluzole oral suspension Teglutik 9/15/2016 Italfarmaco SpA

Prophylactic treatment of Mycobacterium avium complex in patients with AIDS and a CD4+ count less than or equal to 75/mm3.

Hoechst Marion Roussel, Inc.


Onconova Therapeutics, Inc




Sparta Pharmaceuticals, Inc.

Treatment of familial Mediterranean fever

Philip J Hashkes, MD, MSc.

Treatment of gastric cancer including gastroesophageal junction adenocarcinoma

Treatment of spinocereballar ataxia.

Biohaven Pharmaceutical Holding Company, Ltd.


Rhone-Poulenc Rorer Pharmaceuticals, Inc.



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2361

riluzole orally disolving tablet n/a 11/30/20162362

rindopepimut n/a 11/19/20072363

riociguat Adempas 7/24/2014 Treatment of systemic sclerosis2364

risankizumab n/a 11/29/2016 AbbVie Inc.2365

rituximab Rituxan(R); Mabthera(R) 2/23/2015 Genentech, Inc.2366

rituximab n/a 11/9/20162367

rituximab Rituxan 3/12/2002 Genentech, Inc.2368

Rituxin Sc 8/22/2016 Genentech, Inc.2369


Rituximab/hyaluronidase Rituxan 9/7/2016 Genentech, Inc.2371

rociletinib n/a 5/14/2013 Clovis Oncology, Inc.2372

rofecoxib Vioxx 3/16/2004 MERCK & Co., Inc.


Biohaven Pharmaceutical Holding Company, Ltd

Treatment of EGFRvIII-expressing glioblastoma multiforme

Celldex Therapeutics, Inc.

Bayer HealthCare Pharmaceuticals


Treatment of pemphigus vulgaris.

Treatment of Rasmussen's encephalitis



rituximab and recombinant human hyaluronidase


rituximab and recombinant human hyaluronidase



Treatment of non-small cell lung cancer and mutations in the epidermal growth factor receptor



of 400



2373

romiplostim n/a 10/31/2007 Amgen Inc.2374

roneparstat n/a 3/19/2015 Treatment of multiple myeloma2375

n/a 5/19/2016 EMEK, Inc.2376

Rose Bengal Disodium n/a 12/21/20062377

Roseburia hominis Rosburix 8/4/20142378

rovalpituzumab tesirine n/a 12/22/2015 AbbVie Inc.2379

rozrolimupab n/a 9/13/2010 Symphogen A/S2380

rsATP7A cDNA n/a 1/10/2014 Treatment of Menkes disease Stephen G. Kaler, MD2381

rSP-C lung surfactant Venticute 4/3/20002382

rSP-C surfactant Venticute 9/18/2006 Altana Pharma

Treatment of thrombocytopenia associated with myelodysplasia syndrome

Sigma-Tau Research Switerland S.A.

ropidoxuridine (5-iodo-2-pyrimidinone-2'-deoxyribose)

Radiosensitizer to be used during radiation treatment of glioblastoma multiforme.


Provectus Pharmaceuticals, Inc.

Treatment of ulcerative colitis in pediatric patients age 0 through 16 years

4D Pharma Research Ltd


Treatment of primary immune thrombocytopenia.

Treatment of adult respiratory distress syndrome.

Byk Gulden Pharmaceuticals

For use in patients with pneumonia or aspiration of gastric contents leading to intubation, mechanical ventilation, and severe oxygen impairment


of 400



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rt-PA Activase 10/20/2014 Treatment of plastic bronchitis2384

rubitecan n/a 7/17/2002 SuperGen, Inc.2385

rucaparib n/a 7/31/2012 Treatment of ovarian cancer Clovis Oncology, Inc.2386

ruxolitinib Jakafi 11/3/2016 Incyte Corporation2387

Ruxolitinib n/a 7/18/2016 Incyte Corporation2388

ruxolitinib Jakafi 8/16/2013 Treatment of pancreatic cancer Incyte Corporation2389

ruxolitinib phosphate Jakafi 3/22/2010 Incyte Corporation2390

rVIIa-FP n/a 12/22/2011 CSL Behring2391


2/14/2011 Cerus Corporation2393

S-adenosylmethionine n/a 4/30/1998 Treatment of AIDS-myelopathy. Genopia USA, Inc.

Kathleen A Stringer, PharmD, FCCP - Professor

Treatment of pediatric patients infected with human immunodeficiency virus and acquired immunodeficiency syndrome



Treatment of essential thrombocythemia

Treatment and prophyllaxis of bleeding episodes in patients with congenital hemophilia and inhibitors to coagulation factor VIII or IX

S(-)-3-[3-amino-phthalimido]-glutaramide

EntreMed Incorporated

S-59 treated FFP (plasma treated with amotosalen hydrochloride & ultraviolet A light

Intercept Blood System For



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n/a 8/29/2016 TrioxBio, Inc.2395

S-nitrosoglutathione n/a 5/12/20092396

S-nitrosoglutathione n/a 12/28/20122397

n/a 10/20/2009 Treatment of pancreatic cancer MBiotec GmBH2398

n/a 11/16/2015 Treatment of C3 glomerulopathy.

S-ethylisothiourea diethylphosphate

Treatment of symptomatic intradialytic hypotension, including symptomatic hypotension in the immediate post-dialytic period.

Management of cystic fibrosis patients to improve airway clearance and to improve or stabilize pulmonary function

N30 PHARMAceuticals, LLC

Treatment of severe preeclampsia

Salupont Consulting Ltd

S-[2,3-bispalmitoyloxy-(2R)-propyl]-cysteinly-GNNDESNISFKEK

S3,S13-cyclo(D-tyrolsyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-aspartyl-L-tryptophyl-N-methyl-L-glycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-N-methyl-L-isoleucinamide

Amyndas Pharmaceuticals


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n/a 10/9/20142400

sacituzumab govitecan n/a 5/29/2014 Treatment of pancreatic cancer. Immunomedics, Inc.2401

sacituzumab govitecan n/a 11/27/2013 Immunomedics, Inc.2402

salicylic acid 6% n/a 2/17/2012 Orenova Group, LLC2403

salirasib n/a 12/18/2006 Treatment of pancreatic cancer.2404

n/a 10/29/2009 Lithera, Inc.2405

saposin C n/a 2/3/20152406

Sar9, Met(O2)11-Substance P Homspera 3/16/20112407

sarcosine n/a 10/12/2011

S3,S13-cyclo(D-tyrolsyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-aspartyl-L-tryptophyl-N-methyl-L-glycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-N-methyl-L-isoleucinamide)

Treatment of paroxysmal nocturnal hemoglobinuria (PNH)

Amyndas Pharmaceuticals


Treatment of rare congenital ichthyoses.

Kadmon Corporation, LLC

salmeterol xinafoate/fluticasone propionate

Treatment of symptomatic exophthalmos associated with thyroid related eye disease


Bexion Pharmaceuticals, LLC


ImmuneRegen BioSciences, Inc.

Treatment of obsessive compulsive disorder in pediatric patients (0 to 16 years of age)

Guochuan Emil Tsai, MD, PhD


of 400



2408

sargramostim Leukine 11/9/2016 Sanofi Genzyme2409

sarizotan n/a 7/7/2015 Treatment of Rett syndrome.2410

SC-1 monoclonal antibody n/a 11/12/2003 Patrys Limited2411

SDF-1 (108) Lysine Dlmer n/a 7/7/20052412

n/a 4/15/2013 TransDerm, Inc.2413

Secalciferol Osteo-D 7/26/19932414

n/a 6/30/1992 Synergen, Inc.2415

n/a 9/5/2013 BioLineRx, Ltd.

Treatment of individuals acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome)

Newron Pharmaceuticals US, Inc.

Treatment of patients with CD55 (sc-1) positive gastric tumors

Treatment of osteogenic sarcoma

Chemokine Therapeutics Corporation

sdTD-K6a.513a.12; small interfering RNA composed of 2 strands of hybridized RNAs

Treatment of pachyonychia congenita

Treatment of familial hypophosphatemic rickets.


Secretory leukocyte protease inhibitor

Treatment of bronchopulmonary dysplasia.

selective antagonist of the chemokine receptor type 4



of 400



2416

n/a 3/28/20112417

n/a 3/3/20162418

n/a 8/19/20142419

n/a 6/4/19962420

n/a 9/27/2013 Hannah's Hope Fund2421

selinexor n/a 1/5/2015 Treatment of multiple myeloma2422

selinexor n/a 7/7/2016 Treatment of soft tissue sarcoma2423

n/a 5/14/20142424

selisistat n/a 12/7/2009 Siena Biotech SpA

selective deacylglycerol acyltransferase 1 inhibitor

Treatment of hypertriglyceridemia in te setting of Type I hyperlipoproteinemia, also known as Familial Chylomicronemia Syndrome


selective inhibitor of fungal CYP51

Treatment of coccidioidomycosis.

Viamet Pharmaceuticals, Inc.

selective inhibitor of fungal lanosterol demethylase

Treatment of cryptococcal meningitis

Viamet Pharmaceuticals, Inc.

Selective inhibitor of polymorphonuclear leukocyte (PMN) elastase

Therapeutic management of patients with lung disease attributable to cystic fibrosis.

DuPont Pharmaceuticals Company

self-complimentary adeno-associated virus vector, serotype 9, packaging the full lenght GAN gene in the viral capsid

Treatment of Giant Axonal Neuropathy



Selinexor; (Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N-(pyrazin-2-yl)acrylohydrazide





of 400



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selumetinib n/a 5/10/20162426

Seneca Valley virus n/a 8/22/2008 Neotropix, Inc.2427

Imuvert 9/7/1988 Cell Technology, Inc.2428

setmelanotide n/a 9/21/20152429

setmelanotide n/a 4/4/20162430

sevuparin n/a 3/17/2015 Treatment of sickle cell disease Dilaforette AB2431

Short chain fatty acid enema Colomed 8/19/19972432

Short chain fatty acid solution Colomed 5/29/1990 Richard I. Breuer2433

sildenafil Revatio 7/28/2011 Pfizer, Inc.2434

Legalon Sil 2/17/2012 Meda AB

Adjuvant treatment of patients with stage III or stage IV differentiated thyroid cancer.



Serratia marcescens extract (polyribosomes)


Treatment of Prader-Willi Syndrome.

Rhythm Metabolics, Inc.

Treatment of pro-opiomelanocortin (POMC) deficiency due to mutations in the POMC gene

Rhythm Pharmaceuticals, Inc.

Treatment of chronic radiation proctitis.

Richard I. Breuer, M.D.

Treatment of the active phase of ulcerative colitis with involvement restricted to the left side of the colon.

Treatment of pediatric (defined as children less than 17 years of age) pulmonary arterial hypertension

Silibinin-C-2',3-dihydrogensuccinate, disodium salt

Prevention of recurrent hepatitis C in liver transplant patients


of 400



2435

Legalon(R) Sil 9/11/20142436

Flammacerium 11/17/19992437

simtuzumab n/a 1/5/2015 Gilead Sciences, Inc.2438

n/a 7/17/2014 Treatment of Alport syndrome2439

siponimod n/a 7/10/2014 Treatment of dermatomyositis2440

Siponimod n/a 11/26/2013 Treatment of polymyositis2441

sirolimus n/a 3/18/20132442

sirolimus n/a 6/25/20142443

sirolimus n/a 11/17/20112444

sirolimus n/a 6/21/2016 Treatment of beta-thalassemia.

silibinin-C-2',3-dihydrogensuccinate, disodium salt

Treatment of amatoxin poisoning, which includes the prevention and treatment of amatoxin induced hepatic failure

Meda Pharmaceuticals, Inc.

Silver sulfadiazine and cerium nitrate

Treatment of patients with severe dermal burns

Alliance Pharmaceuticals Ltd


single stranded, chemically modified oligonucleotide that binds to and inhibits the function of micro RNA-21

Regulus Therapeutics, Inc.




Palvella Therapeutics LLC

Treatment of lymphangioleiomyomatosis

LAM Therapeutics, Inc.


Cote Orphan Consulting, LLC

Rare Partners srl Impresa Sociale


of 400



2445

sirolimus n/a 11/4/2011 Santen Inc.2446

Coll-R, Sirogen 5/10/20122447

Sitaxsentan Sodium n/a 11/2/20042448

sitimagene ceradenovec Cerepro 7/31/2001 Gliotherapy, Ltd.2449

skin tissue Stratagraft 5/21/2012

Treatment of chronic/refractory anterior noninfectious uveitis, noninfectious intermediate uveitis, noninfectious panuveitis and non-infectious, uveitis affecting the posterior of the eye (NICUPS).

sirolimus in an implantable collagen matrix

Prevention of arteriovenous(AV) fistula or AV graft failure in patients with end stage renal disease, receiving hemodialysis or preparing for hemodialysis

Vascular Therapies, LLC

For the treatment of pulmonary arterial hypertension in the absence of chronic obstructive pulmonary disease or congestive heart failure.

Pfizer Global Research and Development

Use with gancyclovir in the treatment of malignant glioma

Treatment of hospitalized patients with complex skin defects resulting from partial and full thickness skin burns requiring excision and grafting

Stratatech Corporation


of 400



2450

n/a 6/30/2016 Treatment of Ewing sarcoma Tokalas, Inc.2451

small molecule FGFR4 inhibitor n/a 9/14/20152452

n/a 1/21/2016 Treatment of mastocytosis2453

n/a 1/6/20162454

n/a 8/8/2013 Epizyme Inc.2455

n/a 8/15/2013 Epizyme Inc.2456

n/a 9/26/2013 Omeros Corporation2457


smilagenin Cogane 7/21/2011 Junaxo, Inc.2459

sobetirome n/a 4/29/2011 NeuroVia, Inc.

Small molecule Ewing Sarcoma breakpoint region 1/Friend leukemia virus integration 1 fusion protein inhibitor

Treatment of hepatocellular cancer (HCC).

Blueprint Medicines Corporation

small molecule inhibitor of Exon 17 Mutant KIT


Small Molecule Inhibitor of Exon 17 mutant KIT

Treatment of gastrointestinal stromal tumors (GIST).


small molecule inhibitor of histone methyltransferase DOT1L

Treatment of acute lymphoblastic leukemia (ALL)

small molecule inhibitor of histone methyltransferase DOT1L

Treatment of Acute Myeloid Leukemia

small molecule inhibitor of phosphodiesterase 10


small molecule normalizing the p53 function

Critical Outcome Technologies, Inc.


Treatment of X-linked adrenoleukodystrophy


of 400



2460

sodium 2, 2 dimethylbutyrate n/a 7/25/2008 Treatment of sickle cell disease.2461

sodium 2-hydroxylinoleate n/a 8/25/2015 Treatment of neuroblastoma.2462

sodium 2-hydroxylinoleate n/a 11/23/2016 Treatment of pancreatic cancer.2463

sodium 4-phenylbutyrate n/a 10/18/2011 GMP-Orphan SAS2464

n/a 2/24/2016 Treatment of cystic fibrosis. AlgiPharma AS2465

Sodium aluminosilicate n/a 3/4/20052466

Apatone 4/15/20132467

Apatone 7/31/20072468

Apatone 4/15/20132469

Apatone 4/9/2015

HemaQuest Pharmaceuticals, Inc.

Ability Pharmaceuticals, SL

Ability Pharmaceuticals, SL


sodium alginate oligosaccharide

Treatment of chronic hepatic encephalopathy

Castle Creek Pharmaceuticals LLC

sodium ascorbate and menadione sodium bisulfite

Treatment of autosomal dominant polycystic liver disease

IC-Medtech Corporation

Sodium ascorbate and menadione sodium bisulfite

Treatment of metastatic or locally advanced inoperable transitional cell carcinoma of the urothelium (stage III and IV bladder cancer)



Treatment of autosomal dominant polycystic kidney disease



Treatment of noninfected painful total joint without mechanical complication



of 400



2470n/a 12/22/2011

2471

sodium chlorite n/a 8/22/20112472

Sodium dichloroacetate n/a 11/10/19942473

sodium dichloroacetate n/a 7/3/2003 EBD Group2474


sodium dichloroacetate n/a 11/29/20102476


sodium fusidate n/a 10/23/20132478

Borocell 4/15/19922479

sodium nitrite n/a 7/8/2008

sodium benzoate and clozapine

Treatment of treatment-resistant schizophrenia

SyneuRx International Corp.

For slowing the progression of amyotrophic lateral sclerosis.

Neuraltus Pharmaceuticals, Inc.

Treatment of lactic acidosis in patients with severe malaria.

Stacpoole, Peter W. M.D., Ph.D.

Use as an antidote in the management of systemic monochloroacetic acid poisoning

Treatment of congenital lactic acidosis


For pulmonary arterial hypertension.

Peter W. Stackpoole, PhD, MD

Treatment of homozygous familial hypercholesterolemia.


Treatment of patients with prosthetic joint infections

Cempra Pharmaceuticals, Inc.

Sodium Monomercaptoundecahydro-closo-dodecaborate

For use in boron neutron capture therapy (BNCT) in the treatment of glioblastoma multiforme.

Neutron Technology Corp.& Neutron R&D Partner


Airess Pharmaceuticals, Inc.


of 400



2480

Sodium nitrite n/a 1/17/20072481

Sodium nitrite n/a 4/18/2007 Treatment of cyanide poisoning2482



Sodium nitrite n/a 4/2/20072485

sodium nitrite and EDTA n/a 11/10/2015 Arch Biopartners, Inc.2486

Cyanide Antidote Package 3/23/2007 Treatment of cyanide poisoning2487

Ammonul(R) 6/3/2005 Ucyclyd Pharma, Inc.2488

Sodium phenylbutyrate Buphenyl 1/25/2007 OrphaMed, Inc.2489

sodium phenylbutyrate Pheburane 6/6/2013 Lucane Pharma SA

Prevention of vasospasm associated with subarachnoid hemorrhage

Hope Pharmaceuticals


Treatment of chlorine gas poisoning


Prevention of ischemia reperfusion injury to donor organ tissue associated with solid organ transplantation


Treatment of vaso-occlusive crisis associated with sickle cell disease


Treatment of Pseudomonas aeruginosa pulmonary infections in patients with cystic fibrosis

Sodium nitrite/sodium thiosulfate

Keystone Pharmaceuticals, Inc.

Sodium phenylacetate/sodium benzoate 10%/10% Injection

Treatment of grade III and IV hepatic encephalopathy




of 400



2490

Sodium phenylbutyrate n/a 4/24/19982491

sodium phenylbutyrate n/a 1/19/2010 Treatment of urea cycle disorder. Navinta LLC2492

sodium phenylbutyrate n/a 7/2/19922493

Sodium phenylbutyrate n/a 3/20/20072494

sodium phenylbutyrate n/a 8/19/20142495

Sodium pyruvate n/a 3/31/2003 Treatment of cystic fibrosis Cellular Sciences, Inc2496

Sodium stibogluconate n/a 6/16/20062497

sodium stibogluconate n/a 10/28/20092498

Suprep 10/31/2012

For use as an adjuct to surgery, radiation therapy and chemotherapy for the treatment of patients with primary or recurrent malignant glioma.


Treatment for sickling disorders, which include S-S hemoglobinopathy, S-C hemoglobinopathy, and S-thalassemia hemoglobinopathy.

Medicis Pharmaceutical Corp.


Tikvah Therapeutics, Inc.

Treatment of maple syrup urine disease

Acer Therapeutics, Inc.

Treatment of cutaneous leishmaniasis

VioQuest Pharmaceuticals, Inc.

Treatment of cutaneous leishmaniasis

Surgeon General of the US Army

sodium sulfate, potassium sulfate, and magnesium sulfate

For cleansing of the colon in preparation for colonoscopic diagnosis of colonic disease in children and adolescents

Braintree Laboratories, Inc.


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Suclear 9/4/20132500

Sodium tetradecyl sulfate Sotradecol 6/10/1986 Elkins-Sinn, Inc.2501

sodium thiosulfate n/a 10/28/2014 Treatment of dermatomyositis2502

Sodium thiosulfate n/a 3/17/20042503

sodium thiosulfate n/a 12/2/20102504

sodium thiosulfate n/a 11/19/2012 Treatment of calciphylaxis Edinburg BioQuarter2505




Sodium Thiosulfate n/a 2/16/20122509

n/a 12/18/2006 Treatment of cyanide poisoning Akorn, Inc.

sodium sulfate, potassium sulfate, and magnesium sulfate; PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride

For use in cleansing of the colon in preparation for colonoscopy in children and adolescents

Braintree Laboratories, Inc.

Treatment of bleeding esophageal varices.


Prevention of platinum-induced ototoxicity in pediatric patients

Fennec Pharmaceuticals, Inc.

Treatment of extravasation of meclorethamine hydrochloride into subcutaneous tissues.


Treatment of uremic and non-uremic calciphylaxis


Prevention of platinum-induced ototoxicity in pediatric patients


Treatment of sulfur mustard poisoning


Treatment of uremic and non-uremic calciphylaxis


Sodium thiosulfate and sodium nitrite


of 400



2510

Cyanide Antidote Package 6/16/2006 Treatment of cyanide poisoning2511

sodium valproate n/a 8/5/2015 Treatment of Wolfram syndrome2512

sofosbuvir Sovaldi 10/25/2016 Gilead Sciences, Inc.2513

Solasonine and solamargine Coramsine 11/2/20052514

Solasonine and solamargine Coramsine 2/6/20062515

solnatide n/a 2/4/20162516

solnatide n/a 2/8/20162517

n/a 3/6/20002518

n/a 11/21/1994 T Cell Sciences, Inc.

Sodium thiosulfate, sodium nitrite, amyl nitrite

Keystone Pharmaceuticals, Inc.

The University of Birmingham

Treatment of pediatric chronic hepatitis C virus infection


Solbec Pharmaceuticals Limited

Treaatment of high risk stage II, stage III and stage IV melanoma

Solbec Pharmaceuticals Limited

Treatment of primary graft dysfunction following lung transplantation


Treatment of generalized systemic pseudohypoaldosteronism type 1 (also known as autosomal recessive PHA-I or PHA-IB)


Soluble complement receptor type 1

Prevention of post-cardiopulmonary bypass syndrome in children undergoing cardiopulmonary bypass.

Avant Immunotherapeutics, Inc.

Soluble recombinant human complement receptor type 1

Prevention or reduction of adult respiratory distress syndrome.


of 400



2519

Uniplas 12/12/2005 Octapharma USA, Inc.2520

n/a 2/4/20162521

somatorelin Somatrel 8/8/19892522

Somatostatin n/a 12/22/19942523

Somatostatin Zecnil 6/20/19882524

Somatropin Serostim 3/16/2004 EMD Serono, Inc.2525

Somatropin (rDNA) Saizen 5/3/1989 EMD Serono, Inc.

solvent/detergent treated non-blood-group specific human coagulation active plasma


somatic cell therapy product containing hematopoietic progenitor cells (HPC), Facilitating Cells (FC), and alpha beta T cells.

Prevention of organ rejection in living donor kidney transplant recipients


Diagnostic measure of the capacity of the pituitary gland to release growth hormone.

Ferring Laboratories, Inc.


Eumedica Pharmaceuticals A.G. (Schweiz)

Adjunct to the non-operative management of secreting cutaneous fistulas of the stomach, duodenum, small intestine (jejunum and ileum), or pancreas.


Treatment of patients with HIV-associated adipose redistribution syndrome

For the enhancement of nitrogen retention in hospitalized patients suffering from severe burns.


of 400



2526

Serostim 3/26/1996 EMD Serono, Inc.2527

sonidegib n/a 3/23/2015 Treatment of medulloblastoma2528

sotalol hydrochloride Sotylize 2/10/20142529

sotatercept n/a 4/28/2014 Celgene Corporation2530

sotatercept n/a 12/5/2013 Celgene Corporation2531

sparsentan n/a 1/5/2015 Retrophin, LLC2532

n/a 6/21/2016 Treatment of ovarian cancer Kiromic, LLC2533

spherical carbon adsorbent n/a 12/19/2007 Treatment of chronic pouchitis2534

spironolactone Aldactone 5/22/2014 CMP Pharma, Inc.

Somatropin (r-DNA) for injection

Treatment of children with AIDS-associated failure-to-thrive including AIDS-associated wasting.


Treatment of life-threatening ventricular arrhythmias in pediatric patients

Arbor Pharmaceuticals, LLC

Treatment of anemias associated with myelodysplastic syndrome and myelodysplastic/myeloproliferative neoplasms.

Treatment of beta-thalassemia intermedia and major

Treatment of Focal Segmental Glomerulosclerosis

Sperm Protein-17 oral microparticle vaccine

Ocera Therapeutics, Inc.

Use in pediatric patients with primary hyperaldosteronism


of 400



2535

squalamine lactate n/a 5/11/2001 Genaera Corporation2536

stabilized sulforaphane n/a 8/22/2016 Evgen Pharma PLC2537

n/a 6/10/2015 Protalex, Inc.2538

Altastaph 1/29/20042539

Nicord(R) 11/13/2014 Gamida Cell Ltd.2540



stemchymal n/a 12/16/20152543

Accusol 5/29/2009 Nikkiso America, Inc.

Treatment of ovarian cancer refractory or resistant to standard chemotherapy


staphylococcal aureus protein A


Staphylococcus aureus Immune Globulin (Human)

Prophylaxis against Staphylococcus aureus infections in low birth weight neonates


stem/progenitor cells derived from ex vivo expanded allogeneic umbilical cord blood cells



Treatment of Hodgkin lymphoma.



Treatment of polyqlutamine spinocerebellar ataxia

Steminent Biotherapeutics, Inc.

Sterile Bicarbonate Infusate, Hemofiltration, Hemodiafiltration, and Hemopdialysis Solution

For use as a replacement solution in adults and children during Continous Renal Replacement Therapy


of 400



2544Sterile talc Steritalc 12/8/1997 Novatech SA

2545 Sterile talc Steritalc 12/8/1997 Treatment of pneumothorax. Novatech SA2546

stiripentol Diacomit 10/30/2008 Treatment of Dravet syndrome Biocodex2547

n/a 12/22/2015 Qurient Co., Ltd.2548

Succimer Chemet 11/5/1990 Sanofi Winthrop, Inc.2549

Succimer Chemet 3/22/1991 Sanofi Winthrop, Inc.2550

Sucralfate suspension n/a 3/12/19902551

Sucralfate suspension n/a 3/4/19912552

sulfamidase n/a 5/22/20082553

Sulfapyridine n/a 9/10/19902554

n/a 2/17/2012

Treatment of malignant pleural effusion.

Substituted imidazopyridine amide

Treatment of active tuberculosis (TB).

Prevention of cystine kidney stone formation in patients with homozygous cystinuria who are prone to stone development.

Treatment of mercury intoxication.

Treatment of oral complications of chemotherapy in bone marrow transplant patients.

Darby Pharmaceuticals, Inc.

Treatment of oral ulcerations and dysphagia in patients with epidermolysis bullosa.

Darby Pharmaceuticals, Inc.

For treatment of Sanfilippo Syndrome (MPS IIIA)


Treatment of dermatitis herpetiformis.


sulfonated monophosphorylated mannose oligosaccharide


Medigen Biotechnology Corporation


of 400



2555

sulthiame n/a 7/25/20132556

n/a 3/6/19852557

superoxide dismutase, gliadin Etr019 4/30/2010 Verius Limited2558

Suramin Metaret 5/6/19972559

Synsorb Pk n/a 7/17/1995 Synsorb Biotech Inc.2560

n/a 2/4/2016 Treatment of ovarian cancer.

Treatment of patients with benign epilepsy of childhood with centrotemporal spikes (BECTS) also known as rolandic epilepsy


Superoxide dismutase (human)

For protection of donor organ tissue from damage or injury mediated by oxygen-derived free radicals that are generated during the necessary periods of ischemia (hypoxia, anoxia), and especially reperfusion, associated with the operative procedure.

Pharmacia-Chiron Partnership


Treatment of hormone-refractory prostate cancer.


Treatment of verocytotoxogenic E. coli infections.

Synthesized peptide of the L-amino acids with the sequence H-Lys-Glu-Phe-Leu-His-Pro-Ser-Lys-Val-Asp-Leu-Pro-Arg-OH

Soricimed Biopharma Inc.


of 400



2561

n/a 6/4/20142562

n/a 3/31/2015 MYR GmbH2563

Drepanol 10/24/19912564

n/a 4/22/20152565

n/a 8/16/2013 Treatment of hemophilia A2566

n/a 8/12/2013 Treatment of hemophilia B2567

n/a 9/25/2012

synthetic 14-mer phosphorothioate antisense oligonucleotide directed against TGF-beta2 mRNA

Prevention of scarring post glaucoma filtration surgery

Isarna Therapeutics GmbH

Synthetic 47 amino acid-long N-terminally myristoylated, HBV-L-protein derived lipopeptide

Treatment of hepatitis D virus infection.

Synthetic derivative of 16-hydroxy-9Z, 12Z, 14E-octadecatrienoic acid

Prophylactic treatment of sickle cell disease.

Omex International, Inc.

synthetic double-stranded (hybridized duplex) ribonucleic acid oligonucleotide specific to hydroxyacid oxidase 1 gene

Treatment of primary hyperoxaluria type 1

Dicerna Pharmaceuticals, Inc.

synthetic double-stranded siRNA oligonucleotide against antithrombin (AT) mRNA

Alnylam Pharmaceuticals

synthetic double-stranded siRNA oligonucleotide against antithrombin mRNA


Synthetic double-stranded siRNA oligonucleotide against caspase 2 mRNA

Treatment of ischemic optic neuropathy

Quark Pharmaceuticals, Inc.


of 400



2568

n/a 12/23/20092569

n/a 6/14/20122570

n/a 2/8/20162571

n/a 8/29/20162572

Synthetic human secretin n/a 6/16/1999 ChiRhoClin, Inc.2573


Synthetic human secretin n/a 9/18/2006

synthetic double-stranded siRNA oligonucleotide against p53 mRNA

Prophylaxis of delayed graft function in renal transplant patients

Quark Pharmaceuticals, Inc.

synthetic double-stranded siRNA oligonucleotide against transthyretin (TTR) mRNA

Treatment of familial amyloidotic polyneuropathy


synthetic double-stranded siRNA oligonucleotide directed against hydroxyacid oxidase 1 (HAO1) mRNA

Treatment of primary hyperoxaluria type 1


Synthetic double-stranded small interfering RNA (siRNA) oligonucleotide targeting delta-aminoevulinic acid synthase 1

Treatment of acute hepatic porphyria


For use in the evaluation of exocrine pancreas function.

For use in obtaining desquamated pancreatic cells for cytopathologic examination in pancreatic carcinoma.

For use in conjunction with diagnostic procedures (excluding ERCP) for pancreatic disorders to increase pancreatic fluid secretion

Innovate Biopharmaceuticals, Inc.


of 400



2575


n/a 1/13/20152577

n/a 10/12/2011 Atox Bio, Inc.2578

n/a 1/16/20132579

Synthetic porcine secretin n/a 6/18/1999 ChiRhoClin, Inc.2580


n/a 3/16/2012 Chiesi USA, Inc.

For use in conjunction with diagnostic, therapeutic, or combined diagnostic/therapeutic procedures for pancreatic disorders to increase pancreatic fluid secretion.

synthetic oligomer of 16 nucleotides

Treatment of myotonic dystrophy Type I

Ionis Pharmaceuticals, Inc.

synthetic peptide H-D-Ala-Ser-Pro-Met-Leu-Val-Ala-Tyr-Asp-D-Ala-OH

Treatment of necrotizing soft tissue infections (NSTI)

synthetic peptide; cyclo-Cys-Gly-Gln-Arg-Glu-Thr-Pro-Glu-Gly-Ala-Glu-ALA-Lys-Pro-Trp-Tyr-Cys

Treatment of high altitude pulmonary edema


For use in obtaining desquamated pancreatic cells for cytopathologic examination in pancreatic carcinoma.

synthetic signal peptide of human mucin-1 (amino acids 1-21)

Vaxil Bio Therapeutics Ltd.

synthetic surfactant comprised of DPPC, POPG Na, synthetic SP-C analogue and synthetic SP-B analogue

Treatment of preterm neonatal respiratory distress syndrome


of 400



2582

Neurovax 2/6/20142583

n/a 11/1/20012584

n/a 6/27/1989 AGI Dermatics2585

taberminogene vadenovec Trinam 10/24/20002586

tacrolimus n/a 5/4/20152587

tacrolimus n/a 3/16/2015 Selten Pharma, Inc.2588

Tacrolimus Prograf 4/6/1998 Fujisawa USA, Inc.2589

tacrolimus n/a 7/6/20122590

n/a 10/4/20162591

tadalafil Cialis(R); Adcirca(R) 5/4/2015 Eli Lilly and Company

T cell receptor (TCR) peptide (BV5S2, BV6S5, BV13S1) vaccine

Treatment of Pediatric Multiple Sclerosis

Immune Response BioPharma, Inc.

T-cell depleted stem cell enriched cellular product from peripheal b lood stem cells

Treatment of chronic granulomatous disease

Nexell Therapeutics Inc.

T4 endonuclease V, liposome encapsulated

To prevent cutaneous neoplasms and other skin abnormalities in xeroderma pigmentosum.

Prevention of complications due to neointimal hyperplasia disease in certain vascular anastomoses.

Finvector Vision Therapies, Ltd.


Stanford University School of Medicine


Prophylaxis of graft-versus-host-disease.

Treatment of hemorrhagic cystitis

Lipella Pharmaceuticals Inc.

Tacrolimus granules for oral suspension

Prevention of rejection in kidney, liver or heart transplant in pediatric patients.


Treatment of Duchenne Muscular Dystrophy (DMD)


of 400



2592tafamidis n/a 5/23/2006 Pfizer, Inc.

2593

tafamidis meglumine n/a 2/17/2012 Pfizer, Inc.2594

tafenoquine n/a 1/15/2013 Treatment of malaria2595

talactoferrin alfa n/a 8/20/2003 Agennix, Inc.2596

talactoferrin alfa n/a 8/20/2003 Agennix, Inc.2597

Tamibarotene n/a 10/11/2007 CytRx Corporation2598

Tanespimycin n/a 9/9/2004 Treatment of multiple myeloma Bristol-Myers Squibb2599

tarextumab n/a 1/26/2015 Treatment of pancreatic cancer2600

tarextumab n/a 1/26/20152601

n/a 5/14/2014 Treatment of pancreatic cancer Tyg Oncology Ltd2602

tasimelteon n/a 4/30/20102603

taurine n/a 3/22/2010

Treatment of familial amyloid polyneuropathy

Treatment of symptomatic transthyretin (TTR) amyloid cardiomyopathy.

Glaxo Group Limited, England

For the treatment of graft versus host disease

For the prevention of graft-versus-host disease

Treatment of acute promyelocytic leukemia (APL).




Targeted Gastrin 17 Complexed Peptide

Treatment of sleep-wake disorder in Smith-Magenis syndrome associated with diurnal melatonin secretion

Vanda Pharmaceuticals, Inc.

Treatment of cystathionine beta-synthase deficient homocystinuria

Johan L. Van Hove, MD, PhD


of 400



2604taurolidine n/a 5/16/2016 Treatment of pancreatic cancer.

2605tazemetostat n/a 2/4/2016 Epizyme Inc.

2606TD-K6a.513a.12 Reveker 6/15/2006 TransDerm, Inc.

2607

Lymphoscan 4/7/1992 Immunomedics, Inc.2608

Apomate 11/3/20002609

tecovirimat n/a 9/29/20102610

tecovirimat n/a 12/18/20062611

tecovirimat n/a 12/27/2006 Treatment of smallpox.2612

Tegafur/gimeracil/oteracil n/a 7/20/2006 Treatment of gastric cancer2613 telatinib n/a 5/17/2010 Treatment of gastric cancer ACT Biotech Inc.

Geistlich Pharma NA, Inc.

Treatment of malignant rhabdoid tumors (MRTs)


Technetium Tc99m murine monoclonal antibody (IgG2a) to B cell

Diagnostic imaging in the evaluation of the extent of disease in patients with histologically confirmed diagnosis of non-Hodgkin's B-cell lymphoma, acute B-cell lymphoblastic leukemia (in children and adults), and chronic B-cell lymphocytic leukemia.

Technetium Tc99m rh-Annexin V

Diagnosis or assessment of rejection status in heart, heart-lung, single lung, or bilateral lung transplants.

Theseus Imaging Corporation

Treatment of orthopoxvirus infections.

SIGA Technologies, Inc.

post exposure prophylaxis against smallpox



Taiho Pharma USA, Inc.


of 400



2614

telotristat etiprate n/a 3/9/20122615

temocillin sodium Negaban 4/21/2004 Belpharma S.A.2616

Temoporfin Foscan 10/28/19992617

Temozolomide Temodal 10/18/20042618

Temozolomide Temodal 10/14/19982619

temozolomide n/a 11/25/20152620

tenofovir disoproxil fumarate Viread 9/27/2016 Gilead Sciences, Inc.2621

teprotumumab n/a 5/6/2013 River Vision, Inc.2622

terguride Mysalfon, Teluron 5/17/2013 Treatment of systemic sclerosis Medac GmbH2623

Teriparatide Parathar 10/28/1999 Biomeasure, Inc.

Treatment of carcinoid syndrome in patients with neuroendocrine tumors

Lexicon Pharmaceuticals, Inc.

Treatment of pulmonary infections caused by Burkholderia cepacia

Palliative treatment of recurrent, refractory or second primary squamous cell carcinomas of the head and neck in patients considered to be incurable with surgery or radiotherapy.

Biolitec Pharma Ireland Ltd.

Treatment of newly diagnosed high grade glioma

Schering-Plough Research Institute

Treatment of advanced metastatic melanoma.


Treatment glioblastoma multiforme in pediatric patients

AmpliPharm Pharmaceuticals, LLC

Prevention of mother to child transmission of hepatitis B virus

Treatment of active (dynamic) phase Grave's orbitopathy

Treatment of idiopathic osteoporosis.


of 400



2624teriparatide Forteo 4/18/2014 Entera Bio, Ltd.

2625terlipressin n/a 9/8/2016 Bio Vie Inc.

2626Terlipressin Glypressin 3/6/1986

2627terlipressin n/a 10/29/2004

2628 tesetaxel n/a 12/22/2008 Treatment of gastric cancer Genta Inc.2629

tesetaxel n/a 11/21/2008 Genta, Inc.2630

Tesevatinib n/a 3/1/20162631

Testosterone 9/22/1997 Watson Laboratories2632

n/a 7/31/1991 Treatment of vulvar dystrophies.2633

n/a 2/13/2013


Treatment of ascites due to all etiologies except cancer



Treatment of Hepatorenal Syndrome

Ikaria (INO Therapeutics)

Treatment of stages IIB, IIC, III, and stage IV melanoma

Treatment of patients with autosomal recessive polycystic kidney disease (ARPKD)

Kadmon Corporation, LLC

Theraderm Testosterone Transdermal System

For use as physiologic testosterone replacement in androgen deficient HIV+ patients with an associated weight loss.

Testosterone propionate ointment 2%

Star Pharmaceuticals, Inc.

testosterone undecanoate (oral)

Treatment of constitutional delay in growth and puberty in adolescent boys (14-17 yrs of age)

SOV Therapeutics, Inc.


of 400



2634

n/a 1/17/20142635

n/a 3/16/20152636

Tetrabenazine n/a 5/12/19982637

tetrabenazine n/a 7/1/20092638

10/31/2012 Treatment of infantile spasms2639

n/a 6/20/2016 Treatment of infantile spasms2640

Tetraiodothyroacetic acid n/a 5/1/20002641

tetrandrine n/a 5/19/2016

tetra substituted prophyrin derivative containing manganese (III)

For use in patients exposed to radiation following a nuclear accident or detonation in order to treat or mitigate acute radiation syndrome.

Aeolus Pharmaceuticals, Inc.

tetra-substituted porphyrin derivative containing manganese (III)


Aeolus Pharmaceuticals

Treatment of moderate/severe tardive dyskinesia.

Prestwick Pharmaceuticals, Inc.

Treatment of Tourette's Syndrome in school-age children, ages 5-16

Valeant International (Barbados) SRL

tetracosactide hexaacetate (beta 1-24-corticotrophin)

Synacthen Depot, S. Retard

Cerium Pharmaceuticals, Inc.

tetrahydro-N,N-dimethyl-2,2-diphenyl-3-furanmethanamine hydrochloride

Anavex Life Sciences Corp.

Suppression of thyroid stimulating hormone in patients with well-differentiated cancer of the thyroid gland.

Danforth, Jr., MD, Elliot

Treatment of chronic myeloid leukemia.

Escend Pharmaceuticals, Inc.


of 400



2642

Tezacitabine n/a 1/27/20032643

Thalidomide n/a 2/27/1998 Celgene Corporation2644

Thalidomide n/a 5/15/19952645

Thalidomide n/a 7/29/1998 Treatment of Kaposi's sarcoma. Celgene Corporation2646




thalidomide n/a 9/19/19882650

Thalidomide Thalomid 4/6/1999 Treatment of Crohn's disease. Celgene Corporation

Treatment of adenocarcinoma of the esophagus and stomach



Treatment and prevention of recurrent aphthous ulcers in severely, terminally immunocompromised patients.

Andrulis Research Corporation

Treatment of graft versus host disease.


Treatment of severe recurrent aphthous stomatitis in severely, terminally immunocompromised patients.



1. Treatment of graft versus host disease in patients receiving bone marrow transplantation 2. Prevention of graft versus host disease in patients receiving bone marrow transplantation

Pediatric Pharmaceuticals, Inc.


of 400



2651Thalidomide Synovir 3/11/1996 Celgene Corporation

2652



Thalidomide Thalomid 9/27/2004 Celgene Corporation2655

n/a 10/23/2008 Aldagen, Inc.2656

Theranost 68 Ga RGD n/a 10/1/20142657

Theranost 68Ga RGD n/a 1/26/20152658

theranost 68Ga-RGD n/a 12/8/2014

Treatment of HIV-associated wasting syndrome.

Treatment of the clinical manifestations of mycobacterial infection caused by Mycobacterium tuberculosis and non-tuberculous mycobacteria.

Treatment and maintenance of reactional lepromatous leprosy.

Pediatric Pharmaceuticals, Inc.


Thawed donor matched banked umbilical cord blood enriched by cell sorting to produce a subpopulation expressing high levels of intracellular aldehyde dehydrogenase

To improve patient outcomes by decreasing time to platlet and neutrophil engraftment in patients with inherited metabolic diseases (IMD) undergoing umbilical cord blood transplantation.

A Diagnostic for the management of Moyamoya disease (MMD)

Advanced Imaging Projects, LLC (AIP)

Diagnostic for the clinical management of patients with tuberculosis


Diagnostic for clinical management of patients with neuroblastoma



of 400



2659

Thiotepa Tepadina 4/2/2007 Adienne S.A.2660

thioureidobutyronitrile Kevetrin 7/14/2015 Treatment of ovarian cancer2661

thioureidobutyronitrile Kevetrin 11/17/2015 Treatment of retinoblastoma.2662

thioureidobutyronitrile Kevetrin 1/20/2016 Treatment of pancreatic cancer.2663

n/a 7/14/20162664

Thymalfasin Zadaxin 3/6/20002665




thymopentin n/a 2/4/2011 Treatment of sarcoidosis.2669

thymosin beta 4 n/a 12/31/2013 ReGenTree, LLC

Conditioning treatment prior to hematopoietic stem cell transplantation

Cellceutix Corporation



three human IgG1 mAbs (REGN3470, REGN3471, and REGN3479) directed against different epitopes on Ebola virus glycoprotein

Treatment of ebola virus infection



SciClone Pharmaceuticals, Inc.

Treatment of stage IIb through Stage IV malignant melanoma


Treatment of DiGeorge anomaly with immune defects.


Treatment of chronic active hepatitis B.



Treatment of patients with neurotrophic keratopathy


of 400



2670Thymosin beta 4 n/a 5/28/2004 GtreeBNT Co., Ltd

2671

n/a 12/27/20002672

tigecycline n/a 10/23/20132673

Tilarginine acetate n/a 4/11/2005 Treatment of cardiogenic shock2674

tin ethyl etiopurpurin n/a 11/4/20032675

Tiotropium bromide Spiriva 1/8/20082676

tipelukast n/a 10/20/2014 MediciNova, Inc.2677

Tipifarnib Zarnestra 7/6/20042678

tiprelestat Elafin 12/28/2012 Proteo Biotech AG2679

tirapazamine n/a 10/23/20022680

tirapazamine n/a 11/30/2015 Teclison Limited2681

tirasemtiv n/a 3/2/2010 Cytokinetics Inc.

Treatment of epidermolysis bullosa.

Tiazofurin (2-Beta-D-ribofuranosyl-4-thiazolecarboxamide)

Chronic myelogenous leukemia (CML)

Valeant Pharmaceuticals North America


Trillium Therapeutics, Inc.

Arginox Pharmceuticals, Inc.

Prevention of access graft disease in hemodialysis patients

Miravant Medical Technologies

To improve pulmonary function in conjunction with standard therapy in the management of patients with cystic fibrosis




Johnson & Johnson Pharmaceutical Research & Dev.


Treatment of head and neck cancer





of 400



2682

Tiratricol Triacana 8/13/1991 Laphal Laboratoires2683

tisagenlecleucel-T n/a 2/3/20152684

Tissue Plasminogen activator n/a 4/18/20112685

n/a 1/25/2007 Vericel Corporation.2686

n/a 3/13/2006 Treatment of osteonecrosis.2687

tivantinib n/a 10/16/20132688

Tizanidine HCl Zanaflex 1/31/1994

For use in combination with levo-thyroxine to suppress thyroid stimulating hormone in patients with well-differentiated thyroid cancer who are intolerant to adequate doses of levo-thyroxine alone.



Treatment of acute ischemic stroke (AIS) in children age 16 years and younger.

Catherine Amlie-Lefond, MD

Tissue repair cells obtained from autologous bone marrow expanded ex vivo with a cell production system

Treatment of dilated cardiomyopathy

Tissue repair cells obtained from autologous bone marrow expanded ex vivo with a cell production system

Aastrom Biosciences, Inc.

Treatment of hepatocelular carcinoma

Daiichi Sankyo Pharma Development

Treatment of spasticity associated with multiple sclerosis and spinal cord injury.

Athena Neurosciences, Inc.


of 400



2689

Tobramycin Tobi 6/18/19992690

tocilizumab Actemra 4/17/2013 Treatment of systemic sclerosis Genentech, Inc.2691

Tolcapone n/a 12/24/20132692

tolerogen n/a 2/5/2015 Treatment of myasthenia gravis Toleranzia AB2693

tolfenamic acid n/a 7/13/2016 Nasser H. Zawia2694

tolfenamic acid n/a 7/13/2016 Nasser H. Zawia2695

tolvaptan Samsca 4/6/20122696

topiramate injection n/a 7/24/20132697

Toremifene n/a 8/17/1993 Treatment of desmoid tumors. Orion Corporation2698

Tosedostat n/a 12/10/2008

Treatment of bronchiectasis patients infected with Pseudomonas aeruginosa.


Treatment of transthyretin amyloidosis

SOM Innovation Biotech SL (SOM Biotech)

Treatment of Frontotemporal Dementia


Treatment of autosomal dominant polycystic kidney disease

Otsuka Pharmaceuticals Co., Ltd.

Treatment of partial onset or primary generalized tonic-clonic seizures for hospitalized epilepsy patients or epilepsy patients being treated in an emergency care setting who are unable to take oral topiramate

CURx Pharmaceuticals, Inc.




of 400



2699

trabectedin Yondelis 3/29/20052700

trabedersen n/a 7/21/2009 Treatment of pancreatic cancer. Oncotelic, Inc.2701

trabedersen Oncomun 6/5/2002 Treatment of malignant glioma Oncotelic Inc.2702

trabedersen n/a 8/22/2011 Oncotelic, Inc.2703

Tramadol hydrochloride n/a 4/26/20052704

Tramadol hydrochloride n/a 1/28/20052705

Tranilast Rizaben 12/2/20032706

tranilast Rizaben 12/23/2010 Altacor Ltd2707

trans sodium crocetinate n/a 7/21/20112708

trans sodium crocetinate n/a 12/3/2012 Treatment of brain metastasis2709

n/a 12/18/1992

Treatment of patients with ovarian cancer


Treatment of Stage IIB through Stage IV malignant melanoma.





For the treatment of maligant glioma

Angiogen Pharmaceuticals, Pty. Ltd.

Prevention of scarring following glaucoma filtration surgery

Treatment of glioblastoma in conjunction with radiotherapy

Diffusion Pharmaceuticals, LLC

Diffusion Pharmaceuticals, LLC

Transforming growth factor-beta 2

Treatment of full thickness macular holes.

Celtrix Pharmaceuticals, Inc.


of 400



2710

n/a 3/11/2013 Treatment of glioma Eli Lilly and Company2711

n/a 4/1/2013 Eli Lilly and Company2712

n/a 5/19/19992713

trastuzumab Herceptin 12/14/1999 Genentech, Inc.2714 trebananib n/a 8/30/2013 Treatment of ovarian cancer Amgen, Inc.2715

trehalose n/a 11/17/2014 BioBlast Pharma Ltd2716

trehalose Cabaletta 10/25/2013 BioBlast Pharma, Ltd.2717

tremelimumab n/a 3/18/2015 MedImmune, LLC2718

tremelimumab n/a 9/18/2006 MedImmune2719 Treosulfan Ovastat 5/16/1994 Treatment of ovarian cancer. Medac GmbH

transforming growth factor-beta receptor 1 kinase inhibitor

transforming growth factor-beta receptor 1 kinase inhibitor


Transgenic human alpha 1 antitrypsin

Treatment of emphysema secondary to alpha 1 antitrypsin deficiency.

PPL Therapeutics (Scotland) Limited

Treatment of patients with pancreatic cancer that overexpress p185HER2.

Treatment of spinal cerebellar ataxia type 3 (also known as SCA3 or Machado Joseph disease)

Treatment of occulopharyngeal muscular dystrophy


Treatment of stage IIb to stage IV metastatic melanoma


of 400



2720

treosulfan n/a 4/8/2015 Medac GmbH2721

n/a 12/29/20152722

Tretinoin Atra-Iv 4/11/2003 Antigenics, Inc.2723

Tretinoin n/a 4/15/19852724

Tretinoin Atra-Iv 1/14/1993 Antigenics, Inc.2725

n/a 11/23/2001 Cell Works Inc.2726

triciribine n/a 2/1/2008 Treatment of multiple myeloma

Conditioning treatment prior to hematopoietic stem cell transplantation (HSCT) in malignant and non-malignant diseases in adults and pediatric patients.

treprostinil sodium solution enclosed within a pre-filled, pre-programmed, single-use, electronically-controlled infusion pump


SteadyMed Therapeutics


Treatment of squamous metaplasia of the ocular surface epithelia (conjunctiva and/or cornea) with mucous deficiency and keratinization.

Hannan Ophthalmic Marketing Services, Inc

Treatment of acute and chronic leukemia.

tri-antennary glycotripeptide derivative of 5-fluorodeoxyuridine monophosphate

Treatment for hepatocellular carcinoma

VioQuest Pharmaceuticals, Inc.


of 400



2727

triclabendazole Triclathera(Tm) 6/27/2016 Treatment of fascioliasis.2728

trientine hydrochloride Syprine(R) 11/2/2010 Treatment of manganism.2729

trientine tetrahydrochloride n/a 3/10/2016 treatment of Wilson’s disease GMP-Orphan SAS2730

trifarotene n/a 6/6/2014 Galderma R&D, LLC2731

Triheptanoin 5/26/2006 Treatment of fatty acid disorders2732

triheptanoin n/a 10/21/20142733

triheptanoin n/a 4/15/20152734

Triheptanoin 2/1/20082735

triptorelin pamoate n/a 8/20/20122736

Trisaccharides A and B Biosynject 4/20/1987 Chembiomed, Ltd.

Tropicalis Pharmaceuticals, LLC

Cerberus Princeton, LLC

Treatment of congenital ichthyosis

Triheptanoim-Sasol Special Oil

Baylor Research Institute

Treatment of glucose transporter type-1 deficiency syndrome


Treatment of fatty acid oxidation disorders


Triheptanoin-Sasol Special Oil

Treatment of glycogen storage disorder II (Pompe disease)

Baylor Research Institute

Treatment of central precocious puberty


For use in ABO-incompatible solid organ transplantation, including kidney, heart, liver and pancreas.


of 400



2737

Trisaccharides A and B Biosynject 4/12/1987 Chembiomed, Ltd.2738

Trisaccharides A and B Biosynject 4/15/1988 Chembiomed, Ltd.2739

Hemocitrate 6/15/19952740

n/a 2/27/20042741

triterpenoid saponin n/a 7/23/20142742


n/a 1/6/1993 EMD Serono, Inc.

Treatment of moderate to severe clinical forms of hemolytic disease of the newborn arising from placental transfer of antibodies against blood group substances A and B.

Prevention of ABO medical hemolytic reactions arising from ABO-incompatible bone marrow transplantation.

Trisodium citrate concentration

For use in leukapheresis procedures.

Hemotec Medical Products, Inc.

Trisodium zinc Diethylenetriaminepentaacetate

Treatment of patients with known or suspected internal contamination with plutonium, americium, or curium to increase the rate of elimination.

CustomCare Pharmacy


Avicin Therapeutics, Ltd.

Tumor necrosis factor-binding protein 1

Treatment of symptomatic patients with AIDS including all patients with CD4 counts less than 200 cells per mm3.

Tumor necrosis factor-binding protein II

Treatment of symptomatic patients with the AIDS including all patients with CD4 T-cell counts less than 200 cells per mm3.


of 400



2744

n/a 6/9/20152745

TXA127 n/a 10/25/2013 US Biotest, Inc.2746

Tyloxapol Supervent 3/8/1995 Treatment of cystic fibrosis.2747

n/a 2/1/20082748

ubenimex n/a 11/19/20152749

ubiquinol Ubi-Q-Nol, Li-Q-Nol 4/12/20042750

Ubi-Q-Nol 4/12/20042751

Ubiquinone Ubi-Q-Gel 12/14/19992752

ublituximab n/a 9/5/2013 TG Therapeutics, Inc.2753



ublituximab n/a 8/25/2016 TG Therapeutics, Inc.

tumor-inflitrating lymphocytes; LN-144

Treatment of malignant melanoma Stages IIb to IV

Lion Biotechnologies, Inc.

Treament of acute radiation syndrome


Type 1 native bovine skin collagen

Treatment of diffuse systemic sclerosis

arGentis Pharmaceuticals, LLC


Eiger BioPharmaceuticals, Inc.


Gel-Tec, Division of Tishcon Corp.

Ubiquinol, coenzyme Q10, ubiquinone

Treatment of pediatric congestive heart failure

Gel-Tec, Division of Tishcon Corporation

Treatment of mitochondrial cytopathies.

Gel-Tec, Division of Tishcon Corp.

Treatment of Extranodal marginal zone lymphoma (mucosa-associated lymphatic tissue, MALT)

Treatment of Nodal marginal zone lymphoma




of 400



2756

udenafil n/a 8/31/20152757

ulocuplumab n/a 1/12/20152758

urea n/a 11/7/2011 Orenova Group, LLC2759

Urea for intravitreal injection Neurosolve 12/14/20052760

uridine triacetate n/a 9/3/20092761

Urogastrone n/a 11/1/1984 Chiron Vision

Treatment of single ventricle congenital heart disease with Fontan physiology

Mezzion Pharma Co. Ltd.



Treatment of rare congenital ichthyoses (CHILD syndrome, collodion baby, congenital ichthyosform erythroderma, Conradi-flunermann, epidermolytic hyperkeratosis, erythrokeratoderma variabilis, harlequin ichthyosis, KID syndrome, lamellar ichthyosis, Netherton syndrome, neutral lipid storage disease, Sjorgren-Larsson syndrome, trichothiodystrophy, X-linked ichthyosis).


Vitreo Retinal Techologies, Inc

Treatment of mitchondrial disease

Wellstat Therapeutics Corporation

For acceleration of corneal epithelial regeneration and healing of stromal incisions from corneal transplant surgery.


of 400



2762

ursodiol Ursofalk Suspension 10/23/20072763

ustekinumab Stelara 5/18/20162764

ustekinumab Stelara 11/29/20102765

vadastuximab talirine n/a 11/10/2015 Seattle Genetics, Inc.2766

Valine, isoleucine and leucine Vil 1/5/19962767

valine-valine-ganciclovir n/a 5/21/20072768

Valproate n/a 5/5/2008 Treatment of fragile X syndrome Neuropharm Ltd,2769

vancomycin n/a 12/27/2012 Treatment of endophthalmitis2770

n/a 9/20/20122771

vapreotide Sanvar 1/10/2000 Debiovision, Inc.2772

vapreotide Octastatin 1/10/2000 Debiopharm S.A.

Treatment of cystic fibrosis liver disease

Asklepion Pharmaceuticals, LLC

Treatment of pediatric Crohn's disease (0 through 16 years of age)


Treatment of type 1 diabetes mellitus patients with residual beta-cell function.

Johnson & Johnson Pharmaceutical & Development LLC



Leas Research Products

Treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to HSV1 and HSV2.

Verenta Pharmaceuticals, Inc.


vancomycin hydrochloride (inhalational)

Treatment of persistent methicillin-resistant S. aureus lung infection in patients with cystic fibrosis

Savara Pharmaceuticals, Inc.

Treatment of esophageal variceal hemorrhage patients with portal hypertension.

Treatment of gastrointestinal and pancreatic fistulas.


of 400



2773Vapreotide Sanvar 4/6/2004 H3 Pharma, Inc.

2774

vapreotide Octastatin 3/6/2000 Debiopharm S.A.2775 vapreotide Sanvar 11/4/2003 Treatment of acromegaly H3 Pharma, Inc.2776

Varbulin Azixa 11/5/2009 Myrexis, Inc.2777

Varlitinib n/a 8/5/20152778

varlitinib n/a 6/20/2016 Treatment of gastric cancer.2779

n/a 6/24/2008 PhiloGene, Inc.2780

Vasoactive intestinal peptide n/a 3/9/2001 mondoBIOTECH2781

n/a 5/13/20142782

n/a 6/23/1993

Treatment of symptomatic carcinoid tumors

Prevention of early postoperative complications following pancreatic resection.



ASLAN Pharmaceuticals

ASLAN Pharmaceuticals

vascular endothelial growth factor 165b

Treatment of advanced melanoma stages IIb through IV.

Treatment of Acute Respiratory Distress Syndrome.

vasoactive intestinal peptide (VIP)-elastin-like peptide (ELP) fusion protein

Treatment of pulmonary arterial hypertension, WHO Group 1

PhaseBio Pharmaceuticals, Inc.

Vasoactive intestinal polypeptide

Treatment of acute esophageal food impaction.

Research Triangle Pharmaceuticals


of 400



2783

Vasomera n/a 11/19/20152784

vatiquinone Vincerinone 1/31/2014 Treatment of Friedreich's ataxia2785

vatiquinone Vincerinone 11/17/2014 Treatment of Rett syndrome2786

vatiquinone Vincerinone 6/4/2014 Treatment of Leigh Syndrome2787

vedolizumab n/a 8/4/20162788

veliparib n/a 9/3/2009 AbbVie, Inc.2789

veliparib n/a 12/17/2014 AbbVie Inc.2790

veliparib n/a 11/3/2016 AbbVie Inc.

Treatment of cardiomyopathy associated with dystrophinopathies; Duchenne Muscular Dystrophy (DMD), Becker Muscular Dystrophy BMD), and X-linked dilated cardiomyopathy (XL-dCMP).

PhaseBio Pharmaceuticals, Inc.



Edison Pharmaceuticals, Inc.



Treatment of epithelial ovarian cancer in combination with DNA-damaging agents

Treatment of brain metastases when used in combination with DNA-damaging agents

Treatment of squamous non-small cell lung cancer


of 400



2791



veltuzumab n/a 7/28/2015 Immunomedics, Inc.2794

veltuzumab n/a 11/17/2014 Treatment of pemphigus Immunomedics, Inc.2795

veltuzumab n/a 8/28/2008 Immunomedics, Inc.2796

vemurafenib Zelboraf 9/8/2014 Genentech, Inc.2797


vemurafenib Zelboral 8/2/2016 Genentech, Inc.2799


Venetoclax n/a 8/29/2016 Treatment of multiple myeloma AbbVie Inc.2801

venetoclax n/a 2/4/2016 AbbVie Inc.

Treatment of glioblastoma multiforme when used in combination with DNA-damaging agents

Treatment of hepatocellular carcinoma in combination with DNA-damaging agents



Treatment of patients with non-small cell lung cancer (NSCLC) with BRAF V600 mutation

Treatment of anaplastic thyroid carcinoma and advanced papillary thyroid cancer whose tumors harbor a BRAF V600 mutation

Treatment of Erdheim-Chester Disease

Treatment of hairy cell leukemia (HCL).



of 400



2802

verteporfin Visudyne(R) 3/9/20122803

n/a 10/12/20162804

vibriolysin Vibrilase 6/16/20062805

vincristine sulfate liposomes Marqibo 6/24/2008 Talon Therapeutics2806 vintafolide n/a 12/16/2013 Treatment of ovarian cancer Endocyte, Inc.2807

Virulizin Virulizin 2/1/2001 Treatment of pancreatic cancer.2808

vitamin A palmitate n/a 7/14/20152809

n/a 6/23/20152810

volasertib n/a 4/14/20142811

Wilfactin 5/29/2014 rEVO Biologics, Inc.2812

vorinostat n/a 10/13/2016

Treatment of chronic or recurrent central serous chorioretinopathy

Valeant Pharmaceuticals North America LLC

Vibrio alginolyticus collagenase

Treatment of advanced Dupuytren's disease (Dupuytren's contracture)

Fidia Farmaceutici S.p.A.

Debridement of severe, deep dermal burns in hospitalized patients

BioMarin Pharmaceutical Inc.

Treatment of metastatic uveal melanoma.

ZOR Pharmaceuticals, LLC


Advent Therapeutics, Inc.

volanesorsen sodium, apolipotrotein C-III antisense oligonucleotide

treatment of familial chylomicronemia syndrome

Ionis Pharmaceuticals, Inc.



von Willebrand Factor Human Concentrate

Treatment of Von Willebrand Disease

Treatment of advanced melanoma (stages IIb, IIc, III, and IV)

Qameleon Therapeutics


of 400



2813

vosaroxin n/a 10/28/20092814

Aquasol A Parenteral 3/26/2010 Fox Pharma, Inc.2815

n/a 9/27/20162816

Xenogeneic hepatocytes 11/27/1998 Treatment of severe liver failure. Circe Biomedical, Inc.2817

xenon gas n/a 12/3/2014 Neuroprotexeon2818

xenon gas n/a 5/18/2015 Neuroprotexeon2819

n/a 11/30/20162820

Ferritarg P 9/18/2006 Treatment of Hodgkin's disease. Alissa Pharma, LLC2821

n/a 12/3/2012 Treatment of soft tissue sarcoma


Sunesis Pharmaceuticals, Inc.

Water-miscible vitamin A palmitate


Wharton's jelly mesenchymal stem cells

Treatment of graft-versus-host disease

Midwest Stem Cell Therapy Center

Hepatassist Liver Assist System

Treatment of hypoxic ischemic encephalopathy

To improve neurological outcome in hospitalized cardiac arrest patients.

Yersinia pestis plague recombinant antigen (rF1V; F1 capsular protein fused to V antigen; E. coli) vaccine with aluminum hydroxide

Prevention of plague (Yersinia pestis)

DynPort Vaccine Company, LLC, a CSRA Comapny

Yttrium (90Y) antiferritin polyclonal antibodies

Yttrium(90Y)-DTPA-radiolabelled chimeric monoclonal antibody against frizzled homologue 10

OncoTherapy Science, Inc.


of 400



2822

Cea-Cide 8/3/1999 Treatment of ovarian carcinoma. Immunomedics, Inc.2823

Zalcitabine n/a 12/9/1986 Treatment of AIDS.2824

n/a 4/15/2015 Thar Pharmaceuticals2825

zoledronic acid Zometa, Reclast, Aclasta 5/6/20132826

Zosuquidar trihydrochloride n/a 12/15/20052827

n/a 9/17/20082828

n/a 11/4/20032829

n/a 2/14/2014 Daiichi Sankyo, Inc.

Yttrium-90 radiolabeled humanized monoclonal anti-carcinoembroyonic antigen IgG antibody

National Cancer Institute, DCT

zoledronate D,L-lysine monohydrate (ZLM)

Treatment of complex regional pain syndrome (CRPS)

Treatment of complex regional pain syndrome (CRPS).

Axsome Therapeutics, Inc.


Kanisa Pharmaceuticals, Inc.

[131I]-N-(2-(diethylamino) ethyl-4-(4 flurobenzamido)-5-(iodo)-2-methoxybenzamide

Treatment of metastatic melanoma, stages IIB, IIC, III and IV

Molecular Insight Pharmaceuticals, Inc. (Progenics Subsidiary)

[5,10,15,20-tetrakis(1,3-diethylimidazolium-2-yl)porphyrinato] manganese(III)pentachloride


Aeolus Pharmaceuticals, Inc.

[5-(5-Chloro-1H-pyrrolo[2,3-b]pyridin-3-ylmethyl)-pyridin-2-yl]-(6-trifluoromethyl-pyridin-3-ylmethyl)-amine hydrochloride salt

Treatment of pigmented villonodular synovitis/giant cell tumor of the tendon sheath


of 400



2830

n/a 10/20/2014 Treatment of pancreatic cancer Synovo GmbH2831

n/a 5/14/2014 Angiochem, Inc.2832

n/a 1/12/2011 Tocagen, Inc.2833

[F18] florilglutamic acid n/a 7/13/2016 Piramal Imaging S.A.2834

[F18] florilglutamic acid n/a 7/13/2016 Piramal Imaging S.A.2835

n/a 1/12/20092836

[met5]-enkephalin Opioid Growth Factor 1/24/2013 Treatment of pancreatic cancer TNI BioTech, Inc.

[5-Amino-1-(4-fluoro-phenyl)-1H-pyrazol-4-yl]-[3-(2,3-dihydroxy-propoxy)-phenyl]-methanone

[a-N-(2'succinyl-paclitaxel)Thr]-Phe-Phe-Tyr-Gly-Gly-Ser-Arg-Gly-[epsilon-N-(2'succinyl-paclitaxel)Lys]-Arg-Asn-Asn-Phe-[epsilon-N-(2'succinyl-paclitaxel)Lys]-Thr-Glu-Glu-Tyr


[AC3-yCD2(V)] and Flucytosine (5-FC XR)


Diagnostic for the management of hepatocellular carcinoma

For the diagnosis of hepatocellular carcinoma

[Lu-177]-DOTA-Tyr3-Octreotate

Treatment of gastro-entero-pancreatic neuroendocrine tumors

Advanced Accelerator Applications


of 400



2837

n/a 4/15/2015 Angiochem, Inc.2838


Nicord 4/28/2014 Gamida Cell Ltd2840

Dysport(R) 12/5/19912841

acetylcysteine Acetadote 10/19/20012842

Cetylev 2/24/20152843

adalimumab Humira 3/21/2005 AbbVie Inc.2844

adalimumab Humira 10/19/2006 AbbVie, Inc.

[Î±â¿¿N-(2â¿¿succinyl-paclitaxel)Thr]-Phe-Phe-Tyr-Gly-Gly-Ser-Arg-Gly-[Îµâ¿¿N-(2â¿¿succinyl-paclitaxel)Lys]-Arg-Asn-Asn-Phe-[Îµâ¿¿N-(2â¿¿succinyl-paclitaxel)Lys]-Thr-Glu-Glu-Tyr

Treatment of breast cancer patients with brain metastases

{2-amino-8-[4-(pyrrolidinylcarbonyl)phenyl](3H-benzo[f]azepin-4-yl)}-N,N-dipropycarboxamide

VentiRx Pharmaceuticals, Inc.

For the treatment of acute myeloid leukemia

Treatment of essential blepharospasm.


For the intravenous treatment of moderate to severe acetaminophen overdose

Cumberland Pharmaceuticals, Inc.

acetylcysteine effervescent tablets for oral solution

Preventing hepatic injury from acetaminophin overdose

Arbor Pharmaceuticals, Inc.


Treatment of pediatric Crohn's disease.


of 400



2845adalimumab Humira 3/21/2005 AbbVie Inc.

2846



afatinib Gilotrif(R) 8/3/20152849

afatinib Gilotrif 12/3/20122850

Albendazole Albenza 1/17/1996


Treatment of non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis

Treatment of moderate to severe hidradenitis suppurativa (Hurley stage 2 and Hurley stage 3 disease)

Treatment of non-small cell lung cancer with squamous histology.


Treatment of epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).


Treatment of hydatid disease (cystic echinococcosis due to E. granulosus larvae or alveolar echinococcosis due to E. multilocularis larvae).

Amedra Pharmaceuticals LLC


of 400



2851

Albendazole Albenza 1/18/19962852

Aldesleukin Proleukin 9/10/1996 Chiron Corporation2853

Aldesleukin Proleukin 9/14/1988 Chiron Corporation2854

alectinib Alecensa 1/27/2015 Genentech, Inc.2855

alemtuzumab Campath 10/20/1997 Genzyme Corporation2856

Alglucerase injection Ceredase 3/11/1985 Genzyme Corporation2857

Alitretinoin Panretin 3/24/1998 Eisai, Inc

Treatment of neurocysticercosis due to Taenia solium as: 1) chemotherapy of parenchymal, subarachnoidal and racemose (cysts in spinal fluid) neurocysticercosis in symptomatic cases and 2) prophylaxis of epilepsy and other sequelae in asymptomatic neurocysticercosis.

Amedra Pharmaceuticals LLC


Treatment of metastatic renal cell carcinoma.

Treatment of ALK-positive non-small cell lung cancer


For replacement therapy in patients with Gaucher's disease type I.



of 400



2858

Allopurinol sodium Aloprim For Injection 10/16/19922859

Prolastin 12/7/1984 Bayer Corporation2860

Altretamine Hexalen 2/9/19842861

ambrisentan Letairis 7/16/2004 Gilead Colorado2862

Amifostine Ethyol 5/30/19902863

Amifostine Ethyol 5/12/19982864

Aminosalicylic acid Paser Granules 2/19/1992

Management of patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy.

Catalytica Pharmaceuticals, Inc

Alpha1-proteinase inhibitor (human)

For replacement therapy in the alpha-1-proteinase inhibitor congenital deficiency state.

Treatment of advanced adenocarcinoma of the ovary.

Medimmune Oncology, Inc.


For use as a chemoprotective agent for cisplatin in the treatment of advanced ovarian carcinoma.


Reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer.


Treatment of tuberculosis infections



of 400



2865

Amiodarone HCl Cordarone 3/16/19942866

Amphotericin B lipid complex Abelcet 12/5/19912867

Anagrelide Agrylin 1/27/19882868

anakinra Kineret 8/19/20102869

n/a 7/29/20082870

Anthrax Vaccine Adsorbed Biothrax 4/11/20142871

Feiba 4/12/2013 Baxalta US, Inc.2872

Antihemophilic factor (human) Alphanate 1/5/1996 Grifols Biologicals Inc.

For the acute treatment and prophylaxis of life-threatening ventricular tachycardia or ventricular fibrillation.

Wyeth-Ayerst Laboratories

Treatment of invasive fungal infections.

Liposome Company, Inc.

Treatment of essential thrombocythemia.


Treatment of cryopyrin-associated periodic syndromes

Swedish Orphan Biovitrum AB (publ)

anthrax immune globulin (human)

Treatment of inhalational anthrax

Cangene Corp. - Emergent Biosolutions

For post-exposure prophylaxis of anthrax disease resulting from suspected or confirmed Bacillus anthracis exposure

Emergent BioDefense Operations Lansing LLC

anti-inhibitor coagulant complex

Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in hemophilia A and B patients with inhibitors

Treatment of von Willebrand's disease


of 400



2873

Kogenate 9/25/1989 Bayer Corporation2874

Refacto, Xyntha 2/8/19962875

Eloctate 11/23/2010 Treatment of hemophilia A Biogen Idec Inc.2876

Obizur 3/16/2004 Baxalta US, Inc.2877

Humate-P 10/16/1992 CSL Behring2878

Antithrombin III (human) Thrombate Iii 11/26/1984 Bayer Corporation

Antihemophilic factor (recombinant)

Prophylaxis and treatment of bleeding in individuals with hemophilia A or for prophylaxis when surgery is required in individuals with hemophilia A.

Antihemophilic factor (recombinant)

For the control and prevention of hemorrhagic episodes and for surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia).

Wyeth Pharmaceuticals, Inc.

antihemophilic factor (recombinant), Fc fusion protein

antihemophilic factor (recombinant), porcine sequence

Treatment and prevention of episodic bleeding in patients with inhibitor antibodies to human coagulation factor VIII

Antihemophilic factor/von Willebrand factor complex (human), dried, pasteurized

Treatment of patients with von Willebrand's disease

For replacement therapy in congenital deficiency of AT-III for prevention and treatment of thrombosis and pulmonary emboli.


of 400



2879

Antithrombin III (human) Atnativ 2/8/19852880

Anavip 1/29/20042881

Crofab 1/12/1994 Protherics, Inc.2882

Apomorphine HCl Apokyn 4/22/1993 US WorldMeds, LLC

For the treatment of patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism.

Pharmacia & Upjohn AB

Antivenin crotaline (pit-viper) equine immune F(ab)2)

Treatment of envenomation by Crotaline snakes

Rare Disease Therapeutics, Inc.

Antivenin, crotalidae polyvalent immune Fab (ovine)

Treatment of envenomations inflicted by North American crotalid snakes.

Treatment of the on-off fluctuations associated with late-stage Parkinson's disease.


of 400



2883

Aprotinin Trasylol 11/17/1993 Bayer Corporation2884

aripiprazole Abilify 1/25/20062885

Arsenic trioxide Trisenox 3/3/1998 Cephalon2886

artemether/lumefantrine Coartem 8/31/20072887

Asfotase alfa Strensiq 9/12/2008 Treatment of hypophosphatasia

For prophylactic use to reduce perioperative blood loss and the homologous blood transfusion requirement in patients undergoing cardiopulmonary bypass surgery in the course of repeat coronary artery bypass graft surgery, and in selected cases of primary coronary artery bypass graft surgery where the risk of bleeding is especially high (impaired hemostasis) or where transfusion is unavailable or unacceptable.

Treatment of Tourette's syndrome

Otsuka Pharmaceutical Development


For the treatment of infections due to Plasmodium falciparum or mixed infections including P. falciparum.

Novartis Pharmaceuticals



of 400



2888

Atovaquone Mepron 8/14/19912889

Atovaquone Mepron 9/10/1990 Glaxo Wellcome Inc.2890

azacitidine Vidaza 12/3/2001 Celgene Corporation2891

aztreonam Cayston 3/12/20022892

baclofen Lioresal Intrathecal 11/10/1987 Medtronic, Inc.2893

Balsalazide disodium Colazal 8/12/2005

Prevention of Pneumocystis carinii pneumonia (PCP) in high-risk, HIV-infected patients defined by a history of one or more episodes of PCP and/or a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm3.

Glaxo Wellcome Research and Development

Treatment of AIDS associated Pneumocystis Carinii Pneumonia.

Treatament of myelodysplastic syndromes

Inhalation therapy for control of gram-negative bacteria in the respiratory tract of patients with cystic fibrosis

Gilead Sciences (formerly Corus Pharma)

Treatment of intractable spasticity caused by spinal cord injury, multiple sclerosis, and other spinal diseases (including spinal ischemia, spinal tumor, transverse myelitis, cervical spondylosis, and degenerative myelopathy).


Salix Pharmaceuticals, Inc.


of 400



2894

Basiliximab Simulect 12/12/19972895

Sirturo 1/10/2005 Treatment of active tuberculosis2896

belatacept Nulojix 2/20/20082897

Belinostat Beleodaq 9/3/20092898

Bendeka 7/2/20142899

Bendeka 7/2/2014

Prophylaxis of solid organ rejection.


bedaquiline; (1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol


Prophylaxis of organ rejection in renal allograft recipients


Treatment of peripheral T-cell lymphoma (PTCL).

Spectrum Pharmaceuticals, Inc.

bendamustine for 50 ml admixture


Eagle Pharmaceuticals, INc.

bendamustine for 50ml admixture

Treatment of Follicular Lymphoma, Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, Splenic Marginal Zone Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-Associated Lymphoma Tissue (MALT), and Nodal Marginal Zone Lymphoma (Collectively Indolent B-cell Non-Hodgkin's Lymphoma)



of 400



2900

bendamustine hydrochloride Treanda 11/26/2013 Cephalon, Inc.2901

Bendamustine hydrochloride Treanda 8/17/2007 Cephalon, Inc.2902

Benzoate and phenylacetate Ucephan 1/21/1986 ImmunexImmunex2903

benzoate/phenylacetate Ammonul 11/22/1993

Treatment of Follicular Lymphoma, Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, Splenic Marginal Zone Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-Associated Lymphoma Tissue (MALT), and Nodal Marginal Zone Lymphoma (Collectively Indolent B-cell Non-Hodgkin's Lymphoma)


For adjunctive therapy in the prevention and treatment of hyperammonemia in patients with urea cycle enzymopathy due to carbamylphosphate synthetase, ornithine, transcarbamylase, or argininosuccinate synthetase deficiency.

Treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle.



of 400



2904



Betaine Cystadane 5/16/1994 Treatment of homocystinuria. Jazz Pharmaceuticals2907





bevacizumab Avastin 5/26/2006 Treatment of malignant glioma Genentech, Inc.2912

Bexarotene Targretin 6/18/1999 Eisai, Inc.2913

biocarbonate infusate Normocarb Hf 8/9/2005 Dialysis Solutions, Inc.2914

Bleomycin sulfate Blenoxane 9/17/19932915

blinatumomab Blincyto 5/16/2008 Amgen, Inc.


Treatment of neonatal respiratory distress syndrome


Treatment of neonatal respiratory distress syndrome


Treatment of primary peritoneal carcinoma.

Therapeutic treatment of patients with ovarian cancer

Treatment of fallopian tube carcinoma


Use in the management of patients undergoing continuous renal replacement therapy with hemofiltration


Bristol-Myers Squibb Pharmaceutical Research Institute

Treatment of acute lymphocytic leukemia


of 400



2916


bortezomib Velcade 1/15/2003 Treatment of multiple myeloma2918




Bosentan Tracleer 10/6/20002922

bosutinib Bosulf 2/24/20092923

Botulinum toxin type A Botox 3/22/1984 Allergan, Inc.2924

Botulinum toxin type A Botox 3/22/1984 Allergan, Inc.2925

Botulinum toxin type A Dysport 10/20/1999 Ipsen Limited2926

Botulinum toxin type A Botox 8/20/1986 Treatment of cervical dystonia. Allergan, Inc.









Actelion Life Sciences Ltd.



Treatment of strabismus and blepharospasms

Treatment of strabismus and blepharospasms

Treatment of dynamic muscle contractures in pediatric cerebral palsy patients.


of 400



2927Botulinum toxin type B Myobloc 1/16/1992 Treatment of cervical dystonia.

2928

n/a 6/29/2011 Treatment of botulism. Cangene Corporation2929

Botulism immune globulin Babybig 1/31/1989 Treatment of infant botulism.2930




Elliotts B Solution 8/24/1994 Lukare Medical, LLC2934

Buprenorphine hydrochloride Subutex 6/15/19942935

Suboxone 10/27/19942936

Busulfan Busulfex 7/28/1994

Soltice Neurosciences, LLC

botulism antitoxin heptavalent (A, B, C, D, E, F, G) (Equine)

California Department of Health Services

Treatment of anaplastic large cell lymphoma



Buffered intrathecal electrolyte/dextrose injection

For use as a diluent in the intrathecal administration of methotrexate and cytarabine for the prevention or treatment meningeal leukemia and lymphocytic lymphoma

Treatment of opiate addiction in opiate users.

Reckitt Benckiser Pharmaceuticals, Inc.

buprenorphine in combination with naloxone

Treatment of opiate addiction in opiate users

Reckitt Benckiser Pharmaceuticals, Inc.

As preparative therapy in the treatment of malignancies with bone marrow transplantation.

Otsuka Pharmaceutical Company


of 400



2937C1 esterase inhibitor (human) Cinryze(R) 7/16/2004 Treatment of angioedema Shire

2938

Ruconest 2/23/1999 Santarus, Inc.2939

Berinert 10/16/1992 CSL Behring LLC2940

cabozantinib Cometriq 11/29/2010 Exelixis, Inc.2941

Caffeine Cafcit 9/20/19882942

Calcitonin-human for injection Cibacalcin 1/20/19872943

Calcium acetate Phos-Lo 12/22/19882944

calfactant Infasurf 6/7/1985 ONY, Inc.2945

canakinumab Ilaris 9/4/2012

C1-esterase inhibitor (recombinant)

Treatment of (acute attacks of) angioedema caused by hereditary or acquired C1-esterase inhibitor deficiency.

C1-esterase-inhibitor, human, pasteurized

Prevention and/or treatment of acute attacks of hereditary angioedema.

Treatment of follicular, medullary and anaplastic thyroid carcinoma and metastatic or locally advanced papillary thyroid cancer.

Treatment of apnea of prematurity.

O.P.R. Development, L.P.

Treatment of symptomatic Paget's disease (osteitis deformans).


Treatment of hyperphosphatemia in end stage renal failure.

Fresenius Medical Care North America

Treatment and prevention of respiratory failure due to pulmonary surfactant deficiency in preterm infants.

Treatment of TNF-receptor associated periodic syndrome (TRAPS)



of 400



2946





capsaicin Qutenza 5/22/20092951

carfilzomib Kyprolis 1/18/2008 Treatment of multiple myeloma2952

carglumic acid Carbaglu 1/20/1998 Orphan Europe SARL2953

Centruroides immune F(ab)2 Anascorp 6/12/20002954

Fabrazyme 1/19/1988 Treatment of Fabry's disease. Genzyme Corporation

Treatment of pediatric (age 16 and under) juvenile rheumatoid arthritis.


Treatment of familial mediterranean fever


Treatment of cryopyrin-associated periodic syndromes


Treatment of hyperimmunoglobulinemia D and periodic fever syndrome


Management of neuropathic pain in patients with postherpetic neuralgia



Treatment of N-acetylglutamate synthetase deficiency.

Treatment of scorpion envenomations requiring medical attention.

Rare Disease Therapeutics, Inc.

Ceramide trihexosidase/alpha-galactosidase A


of 400



2955

ceritinib Zykadia 9/27/20132956

cetuximab Erbitux 7/3/20002957

chenodiol Chenix 9/21/1984 Solvay2958

cholic acid Cholbam 7/18/2003 Retrophin, Inc.2959

cinacalcet Sensipar 5/12/2003 Amgen, Inc.

Treatment of patients with non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase(ALK)-positive


Treatment of squamous cell cancer of the head and neck in patients who express epidermal growth factor receptor

ImClone Systems Incorporated

For patients with radiolucent stones in well opacifying gallbladders, in whom elective surgery would be undertaken except for the presence of increased surgical risk due to systemic disease or age

Treatment of inborn errors of cholesterol and bile acid synthesis and metabolism

Treatment of hypercalcemia in patients with parathyroid carcinoma


of 400



2960



Renacidin Irrigation 8/28/1989 United-Guardian, Inc.2963

Cladribine Leustatin Injection 11/15/1990 Treatment of hairy cell leukemia.2964

clobazam Onfi 12/18/2007 Lundbeck, Inc.2965

clofarabine Clolar 2/7/2002 Genzyme Corporation

Treatment of hypercalcemia in patients with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo surgery

Treatment of hypercalcemia in patients with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo surgery

Citric acid, glucono-delta-lactone and magnesium carbonate

Treatment of renal and bladder calculi of the apatite or struvite variety.


Treatment of Lennox-Gastaut Syndrome



of 400



2966

Clofazimine Lamprene 6/11/19842967

Clonidine Duraclon 1/24/19892968

Coagulation factor IX Mononine 6/27/19892969

Coagulation Factor IX (human) Alphanine 7/5/1990

Treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum.


For continous epidural administration as adjunctive therapy with intraspinal opiates for the treatment of pain in cancer patients tolerant to, or unresponsive to, intraspinal opiates.

Roxane Laboratories, Inc.

Replacement treatment and prophylaxis of the hemorrhagic complications of hemophilia B.

Armour Pharmaceutical Company

For use as replacement therapy in patients with hemophilia B for the prevention and control of bleeding episodes, and during surgery to correct defective hemostasis.



of 400



2970

Rixubis 10/31/2012 Baxalta US, Inc.2971

Benefix 10/3/1994 Treatment of hemophilia B.2972

Alprolix 10/30/2008 Biogen Idec Inc.2973

Novoseven 7/21/2004 Novo Nordisk, Inc.2974


Novoseven 6/6/1988 Novo Nordisk, Inc.

coagulation factor IX (recombinant)

Prophylactic use to prevent or reduce the frequency of bleeding episodes in patients with hemophilia B (routine prophylaxis in patients where there is no evidence or suspicion of bleeding)

Coagulation Factor IX (recombinant)


Coagulation factor IX (recombinant), Fc fusion protein

Control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease)


Prevention of bleeding episodes in patients with acquired inhibitors to Factor VIII or Factor IX


Treatment of bleeding episodes in patients with congenital factor VII deficiency


Treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX.


of 400



2976




Novoseven Rt 6/18/2004 Novo Nordisk Inc.2980

Tretten 11/6/2003 Novo Nordisk, Inc.2981

cobimetinib n/a 1/31/2014 Genentech, Inc.2982

n/a 12/19/20072983

colchicine Colcrys 9/25/2007


Prevention of bleeding episodes in patients with congenital Factor VII deficiency


Prevention of bleeding episodes in patients with hemophilia A or B, with or without inhibitors

Coagulation Factor VIIa (Recombinant)

Treatment of bleeding episodes in patients with acquired inhibitors to Factor VIII or Factor IX

coagulation factor VIIa (recombinant)

Treatment of bleeding episodes in Glanzmann's thrombasthenia

coagulation factor XIII A-subunit (recombinant)

Prophylaxis of bleeding associated with congential factor XIII deficiency

Treatment of stage IIb, IIc, III, and IV melanoma with BRAFV600 mutation

coccidioidin SD Skin Test Antigen

For the diagnosis of Coccidioidomycosis

Allermed Labortories, Inc.

Treatment of familial Mediterranean fever

AR Holding Company, Inc.


of 400



2984

10/20/1989 Glaxo Wellcome Inc.2985

Xiaflex 5/23/19962986

Xiaflex 3/12/1996 Treatment of Peyronie's disease.2987

n/a 10/9/20142988

Corticorelin ovine triflutate Acthrel 11/24/19892989

crizotinib Xalkori 9/13/2010 Pfizer, Inc.

Colfosceril palmitate, cetyl alcohol, tyloxapol

Exosurf Neonatal For Intratracheal Suspension

1. Prevention of hyaline membrane disease, also known as respiratory distress syndrome, in infants born at 32 weeks gestation or less 2. prevention of hyaline membrane disease (HMD), also known as respiratory distress syndrome (RDS), in infants born at 32 weeks gestation or less and in the treatment of established HMO at all gestational ages.

collagenase clostridium histolyticum

Treatment of advanced (involutional or residual stage) Dupuytren's disease.

Auxilium Pharmaceuticals, Inc.

collagenase clostridium histolyticum

Auxilium Pharmaceuticals, Inc.

Combination of nivolumab and ipilimumab

Treatment of Stage IIb to Stage IV melanoma


For use in differentiating pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushings syndrome.


Treatment of ALK-positive, MET-positive, or ROS-positive non-small cell lung cancer


of 400



2990 Cromolyn sodium Gastrocrom 3/8/1984 Treatment of mastocytosis. Fisons Corporation2991

7/24/1985 Fisons Corporation2992

Cysteamine Cystagon 1/25/19912993

cysteamine enteric coated Procysbi 10/24/2006 Treatment of cystinosis Horizon Orphan LLC2994

cysteamine enteric coated Procysbi 10/24/2006 Treatment of cystinosis Horizon Orphan LLC2995

Cysteamine hydrochloride Cystaran 8/19/19972996

Cytarabine liposomal Depocyt 6/2/19932997

Cytogam 8/3/1987 CSL Behring LLC2998

dabrafenib Tafinlar 1/12/20112999

Daclizumab Zenapax 3/5/19933000

dalfampridine Ampyra 6/2/1987 Acorda Therapeutics3001

Ryanodex 8/16/2013

Cromolyn sodium 4% ophthalmic solution

Opticrom 4% Ophthalmic Solution

Treatment of vernal keratoconjunctivitis.

Treatment of nephropathic cystinosis.

Mylan Laboratories, Inc.

Treatment of corneal cystine crystal accumulation in cystinosis patients.


Treatment of neoplastic meningitis.

Pacira Pharmaceuticals, Inc.

Cytomegalovirus immune globulin (human)

Prevention or attenuation of primary cytomegalovirus disease in immunosuppressed recipients of organ transplants.

Treatment BRAF V600 mutation positive Stage IIB through IV melanoma


Prevention of acute renal allograft rejection.


Relief of symptoms of multiple sclerosis

dantrolene sodium suspension for injection

Treatment of malignant hyperthermia syndrome



of 400



3002daratumumab Darzalex 5/6/2013 Treatment of multiple myeloma. Janssen Biotech, Inc.

3003daratumumab Darzalex 5/6/2013 Treatment of multiple myeloma. Janssen Biotech, Inc.

3004

Dasatinib Sprycel 11/18/20053005

Dasatinib Sprycel 11/28/20053006

Daunoxome 5/14/19933007

decitabine Dacogen 3/8/19993008

Deferasirox Exjade 11/21/20023009

deferasirox Exjade 2/24/20153010

deferiprone Ferriprox 12/12/20013011

defibrotide Defitelio 5/21/20033012

denileukin diftitox Ontak 8/21/1996 Eisai, Inc.

Treatment of Philadelphia-positive acute lymphoblastic leukemia




Daunorubicin citrate liposome injection

Treatment of patients with advanced HIV-associated Kaposi's sarcoma.

NeXstar Pharmaceuticals, Inc.


Otsuka Pharmaceutical Development

Treatment of chronic iron overload in patients with transfusion-dependent anemias


Treatment of chronic iron overload in alpha-thalassemia


Treatment of iron overload in patients with hematologic disorders requiring chronic transfusion therapy

ApoPharma, Inc. A Division of

For the treatment of hepatic veno-occlusive disease


Treatment of patients with cutaneous T-cell lymphoma


of 400



3013denosumab Xgeva 12/20/2010 Amgen, Inc.

3014denosumab Xgeva 9/11/2013 Amgen, Inc.

3015

Desmopressin acetate n/a 1/22/1991 Aventis Behring L.L.C.3016

Ozurdex 9/11/1998 Allergan3017

Dexrazoxane Zinecard 12/17/1991 Pharmacia & Upjohn3018

dexrazoxane Totect(R) 3/25/20043019

n/a 2/25/19923020

dichlorphenamide n/a 9/2/2010 Taro Pharmaceuticals

Treatment of patients with giant cell tumor of bone

Treatment of hypercalcemia in malignancy

Treatment of mild hemophilia A and von Willebrand's disease.

dexamethasone intravitreal implant

Treatment of non-infectious ocular inflammation of the posterior segment in patients with intermediate, posterior, and panuveitis

For the prevention of cardiomyopathy associated with doxorubicin administration.

Treatment of anthracycline extravasation during chemotherapy

Clinigen Healthcare Ltd.

Diazepam viscous solution for rectal administration

For the management of selected, refractory, patients with epilepsy, on stable regimens of antiepileptic drugs (AEDs), who require intermittent use of diazepam to control bouts of increased seizure activity.

Valeant Pharmaceuticals

Treatment of primary periodic paralyses


of 400



3021

n/a 4/28/20043022

difluprednate Durezol 9/30/20083023

Digoxin immune FAB (Ovine) Digibind 11/1/1984 Glaxo Wellcome Inc.3024

dinutuximab Unituxin 12/20/2010 Treatment of neuroblastoma3025

Dornase alfa Pulmozyme 1/16/1991 Genentech, Inc.3026

Doxil 12/29/2004 Treatment of multiple myeloma3027 Doxorubicin liposome Doxil 11/4/1998 Treatment of ovarian cancer. Alza Corporation3028

Dronabinol Marinol 1/15/1991

Diethylenetriaminepentaacetic acid (DTPA)

Treatment of patients with known or suspected internal contamination with plutonium, americium, or curium to increase the rates of elimination.

Hameln Pharmaceuticals gmbh

Treatment of endogenous and traumatic anterior uveitis and panuveitis.

Alcon Pharmaceuticals. Ltd.

Treatment of potentially life threatening digitalis intoxication in patients who are refractory to management by conventional therapy.

United Therapeutics Corporation

To reduce mucous viscosity and enable the clearance of airway secretions in patients with cystic fibrosis.

doxorubicin HCL liposome injection

Johnson & Johnson Pharmaceutical Research & Dev.

For the stimulation of appetite and prevention of weight loss in patients with a confirmed diagnosis of AIDS.

Unimed Pharmaceuticals, Inc.


of 400



3029

droxidopa Northera 1/17/2007 Lundbeck LLC3030 ecallantide Kalbitor 2/4/2003 Treatment of angioedema Dyax Corp.3031 ecallantide Kalbitor 2/4/2003 Treatment of angioedema Dyax Corp.3032



Eflornithine HCl Ornidyl 4/23/19863035

eliglustat Cerdelga 9/17/2008 Genzyme Corporation3036

elosulfase alfa Vimizim 5/15/20093037

elotuzumab Empliciti 9/1/2011 Treatment of multiple myeloma3038

eltrombopag Promacta 11/8/2013 Treatment of aplastic anemia

Treatment of neurogenic symptomatic orthostatic hypotension in patients with primary autonomic failure, dopamine-beta-hydroxylase deficiency, and nondiabetic autonomic neuropathy.



Treatment of atypical hemolytic uremic syndrome


Treatment of Trypanosoma brucei gambiense infection (sleeping sickness).

Hoechst Marion Roussel

Treatment of Type I Gaucher disease

Use in the treatment of mucopolysaccharidosis (MPS) Type IV A (Morquio A syndrome)

BioMarin Pharmaceutical Inc.




of 400



3039

eltrombopag Promacta 5/5/20083040

Epirubicin Ellence 9/14/1999 Treatment of breast cancer.3041

Epoetin alfa Epogen 4/10/1986 Amgen, Inc.3042

Epoetin alfa Epogen 7/1/1991 Amgen, Inc.3043

epoprostenol Flolan 3/22/1999 GlaxoSmithKline3044

Epoprostenol Flolan 9/25/1985 Glaxo Wellcome Inc.3045

eribulin mesylate Halaven 5/14/2012 Treatment of soft tissue sarcoma Eisai Inc.3046

Erwinia L-asparaginase Erwinase 7/30/19863047

etanercept Enbrel 10/27/1998 Immunex Corporation

Treatment of idiopathic thrombocytopenia purpura


Pharmacia & Upjohn Company


Treatment of anemia associated with HIV infection or HIV treatment.

Treatment of secondary pulmonary hypertension due to intrinsic precapillary pulmonary vascular disease.

Treatment of primary pulmonary hypertension.

Treatment of acute lymphocytic leukemia.


Reduction in signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.


of 400



3048eteplirsen Exondys 51 10/23/2007

3049

Ethanolamine oleate Ethamolin 3/22/1984 QOL Medical3050

ethiodized oil injection Lipiodol 9/26/2013 Guerbet LLC3051

Etidronate disodium Didronel 3/21/1986 MGI Pharma, Inc.3052





Treatment of patients with esophageal varices that have recently bled, to prevent rebleeding.

Management of patients with known hepatocellular carcinoma (HCC)

Treatment of hypercalcemia of malignancy inadequately managed by dietary modification and/or oral hydration.



Treatment of tuberous sclerosis complex including TSC-associated subependymal giant cell astrocytoma (SEGA), TSC-associated angiomyolipoma and TSC-associated lymphangioleiomyomatosis (LAM)



of 400



3054



evolocumab Repatha 9/12/2013 Amgen Inc.3057

Exemestane Aromasin 9/19/1991 Pharmacia & Upjohn3058

Corifact 1/16/1985 CSL Behring LLC3059

Corifact 1/16/1985 CSL Behring LLC3060

Felbamate Felbatol 1/24/1989 Wallace Laboratories3061

Filgrastim Neupogen 10/1/1990 Amgen, Inc.

Treatment of tuberous sclerosis complex including TSC-associated subependymal giant cell astrocytoma (SEGA), TSC-associated angiomyolipoma and TSC-associated lymphangioleiomyomatosis (LAM)





Treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.

factor XIII concentrate (human)

Treatment of congenital factor XIII deficiency

factor XIII concentrate (human)

Treatment of congenital factor XIII deficiency

Treatment of Lennox-Gastaut syndrome.

Treatment of neutropenia associated with bone marrow transplants.


of 400



3062

Filgrastim Neupogen 7/17/1995 Amgen, Inc.3063

filgrastim Neupogen 11/20/2013 Amgen, Inc.3064



Fludarabine phosphate Fludara 4/18/19893067

n/a 12/18/20073068

Fluocinolone Retisert 7/31/2000

For use in the mobilization of peripheral blood progenitor cells for collection in patients who will receive myeloablative or myelosuppressive chemotherapy.

Treatment of subjects at risk of developing myelosuppression after a radiological or nuclear incident

Treatment of patients with severe chronic neutropenia (absolute neutrophil count less than 500/mm3).

Reduction in the duration of neutropenia, fever, antibiotic use, and hospitalization, following induction and consolidation treatment for acute myeloid leukemia.

Treatment of chronic lymphocytic leukemia (CLL), including refractory CLL.


Fludarabine phosphate oral tablets

Treatment of B-cell chronic lymphocytic leukemia

Sanofi-Aventis U.S., Inc.

Treatment uveitis involving the posterior segment of the eye.

Bausch & Lomb Pharmaceuticals, Inc.


of 400



3069

Follitropin alfa, recombinant Gonal-F 12/21/1998 EMD Serono, Inc.3070

Fomepizole Antizole 12/22/1988 Jazz Pharmaceuticals3071

Fomepizole Antizole 12/22/1988 Jazz Pharmaceuticals3072

Fosphenytoin Cerebyx 6/4/19913073

gabapentin Gralise 11/8/2010 Depomed, Inc.3074

gabapentin enacarbil Horizant 6/7/2011

For the initiation and re-initiation of spermatogenesis in adult males with reproductive failure due to hypothalamic or pituitary dysfunction, hypogonadotropic hypogonadism. AMENDED indication 6/27/00: For the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.

Treatment of methanol or ethylene glycol poisoning.

Treatment of methanol or ethylene glycol poisoning.

For the acute treatment of patients with status epilepticus of the grand mal type.






of 400



3075

Netspot 12/31/20133076

ganciclovir Zirgan 3/22/20073077

Ganciclovir intravitreal implant Vitrasert Implant 6/7/19953078

gefitinib Iressa 8/26/20143079

Gemtuzumab ozogamicin Mylotarg 11/24/19993080

Glatiramer acetate Copaxone 11/9/1987 Treatment of multiple sclerosis.3081

glucarpidase Voraxaze 8/19/2003 BTG International Inc.

Gallium [Ga-68]-N-[(4,7,10-Tricarboxymethyl-1,4,7,10-tetraazacyclododec-1-yl)acetyl]-D-phenylalanyl-L-cysteinyl-L-tyrosyl-D-tryptophanyl-L-lysyl-L-threoninyl-L-cysteinyl-L-threonine-cyclic(2-7)disulfide

Diagnostic for the clinical management of neuroendocrine tumors

Advanced Accelerator Applications, USA

Treatment of acute herpetic keratitis (dendritic and geographic ulcers)

Sirion Therapeutics, Inc.

Treatment of cytomegalovirus retinitis.

Bausch & Lomb Surgical, Chiron Vision Products

Treatment of epidermal growth factor receptor mutation-positive non-small cell lung cancer



Wyeth Pharmaceuticals, Inc., a Pfizer Company


Treatment of patients at risk of methotrexate toxicity


of 400



3082

Glutamine Nutrestore 3/6/1995 Emmaus Medical, Inc.3083

glycerol phenylbutyrate Ravicti 4/27/2009 Horizon Pharma, Inc.3084

glycopyrrolate Cuvposa 6/9/2006 Shionogi, Inc.3085

Gonadorelin acetate Lutrepulse 4/22/19873086

Halofantrine Halfan 11/4/1991

For use with human growth hormone in the treatment of short bowel syndrome (nutrient malabsorption from the gastrointestinal tract resulting from an inadequate absorptive surface).

Maintenance treatment of patients with deficiencies in enzymes of the urea cycle

Treatment of pathologic (chronic moderate to severe) drooling in pediatric patients

For induction of ovulation in women with hypothalamic amenorrhea due to a deficiency or absence in the quantity or pulse pattern of endogenous GnRH secretion.


Treatment of mild to moderate acute malaria caused by susceptible strains of P. falciparum and P. vivax.



of 400



3087

Hemin Panhematin 3/16/1984 Abbott Laboratories3088

Hepagam 3/24/2008 Cangene Corporation3089

Histrelin Supprelin La 11/18/20053090

Histrelin acetate Supprelin Injection 8/10/19883091

Human factor X Coagadex 11/8/20073092

Riastap 3/13/2008 CSL Behring, LLC3093

Yervoy 10/21/2010

Amelioration of recurrent attacks of acute intermittent porphyria (AIP) temporarily related to the menstrual cycle in susceptible women and similar symptoms which occur in other patients with AIP, porphyria variegata and hereditary coproporphyria.

hepatitis B immune globulin (human)

Prevention of hepatitis B recurrence following orthotopic liver transplant


Endo Pharmaceuticals Solutions, Inc.



Treatment of hereditary factor X deficiency

Bio Products Laboratory

human fibrinogen concentrate, pasteurized

Treatment of fibrinogen deficient patients.

human monoclonal anti-PA antibody

For post-exposure prophylaxis and treatment of inhalation anthrax.

Emergent Product Development Gaithersburg, Inc.


of 400



3094

Wilate 4/18/2007 Octapharma USA, Inc.3095

Hydroxocobalamin Cyanokit 11/25/2003 SERB, S.A.3096

hydroxyprogesterone caproate Makena 1/25/20073097

Hydroxyurea Droxia 10/1/19903098

ibritumomab tiuxetan Zevalin 9/6/19943099






ibrutinib Imbruvica 4/6/2012 Pharmacyclics, LLC

Human plasma coagulation Factor VIII and human plasma von Willebrand Factor

Treatment of von Willebrand disease except for surgical and/or invasive procedures in patients with von Willebrand disease in whom desmopressin is either ineffective or contraindicated

Treatment of acute cyanide poisoning

Prevention of preterm birth in singleton pregnancies

KV Pharmaceutical Company

Treatment of patients with sickle cell anemia as shown by the presence of hemoglobin S.


Treatment of B-cell non-Hodgkin's lymphoma.





Treatment of small lymphocytic lymphoma




of 400



3105Ibuprofen lysine Neoprofen 10/29/1996 Lundbeck, Inc.

3106icatibant Firazyr 11/25/2003 Treatment of angioedema

3107

7/18/19973108

Idarubicin HCl for injection Idamycin 7/25/19883109

idarucizumab n/a 5/28/20153110

idelalisib Zydelig 9/26/2013 Gilead Sciences, Inc.3111

idelalisib Zydelig 10/15/2013 Gilead Sciences, Inc.

Treatment of patent ductus arteriosus

Shire Orphan Therapies

Icodextrin 7.5% with Electrolytes Peritoneal Dialysis Solution

Extraneal (With 7.5% Icodextrin) Peritoneal Dialysis Solutio

Treatment of those patients having end stage renal disease and requiring peritoneal dialysis treatment.


Treatment of acute myelogenous leukemia, also referred to as acute nonlymphocytic leukemia.

Adria Laboratories, Inc.

To reverse the anticoagulant effect of dabigatran due to uncontrolled life-threatening bleeding requiring urgent intervention or a need to undergo an emergency surgery/urgent invasive procedure



Treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma


of 400



3112

idursulfase Elaprase 11/28/20013113

Ifosfamide Ifex 1/20/1987 Treatment of testicular cancer.3114

Iloprost inhalation solution Ventavis 8/17/2004 CoTherix, Inc.3115

imatinib Gleevec 10/11/20053116

Imatinib Gleevec 1/31/20013117

imatinib Gleevec 10/11/20053118

imatinib mesylate Gleevec 11/1/20013119



Long term enzyme replacement therapy for patients with mucopolysaccharidosis II (Hunter Syndrome)










Treatment of gastrointestinal stromal tumors


Treatment of gastrointestinal stromal tumors


Treatment of dermatofibrosarcoma protuberans



of 400



3121

Imatinib mesylate Gleevec 10/5/20053122



Imiglucerase Cerezyme 11/5/1991 Genzyme Corporation3125

Immune Globulin (Human) Gamunex(R)-C 7/27/20043126

Gammagard Liquid 7/20/2006 Baxalta US, Inc.3127

Gamimune N 2/18/1993 Bayer Corporation3128

Gammaplex 4/29/2011

Treatment of myeloproliferative disorders/myelodysplastic syndromes associated with platelet-derived growth factor gene re-arrangements


Treatment of systemic mastocytosis without the D816V c-kit mutation


Treatment of idiopathic hypereosinophilic syndrome including acute and chronic eosinophilic leukemia


Replacement therapy in patients with types I, II, and III Gaucher's disease.



immune globulin infusion (human)

Treatment of multifocal motor neuropathy

Immune globulin intravenous, human

Infection prophylaxis in pediatric patients affected with the human immunodeficiency virus.

immune globulin intraveous (human)

Treatment of idiopathic thrombocytopenic purpura (also known as primary immune thrombocytopenia)

Bio Products Laboratory


of 400



3129

Infliximab Remicade 11/12/2003 Centocor, Inc.3130 infliximab Remicade 11/14/1995 Treatment of Crohn's disease Centocor, Inc.3131

infliximab Remicade 11/12/2003 Janssen Biotech Inc.3132

Interferon alfa-2a Roferon A 6/6/19893133

Roferon-A 12/14/19873134

Intron A 6/24/1987 Schering Corporation3135

Interferon beta-1a Avonex 12/16/1991 Treatment of multiple sclerosis. Biogen, Inc.3136

Interferon beta-1b Betaseron 11/17/1988 Treatment of multiple sclerosis.3137

Interferon gamma 1-b Actimmune 9/30/19883138

Interferon gamma-1b Actimmune 9/30/19963139

intravenous carbamazepine Carnexiv 6/27/2013 Lundbeck LLC3140

Iobenguane I 123 Adreview 12/1/2006 GE Healthcare, Inc.3141

Iobenguane I 123 Adreview 12/1/2006 GE Healthcare, Inc.

Treatment of pediatric (0 to 16 years of age) Crohn's Disease

Treatment of pediatric (0 to 16 years of age) ulcerative colitis




Treatment of AIDS related Kaposi's sarcoma.


Interferon alfa-2b (recombinant)


Chiron Corp. & Berlex Laboratories

Treatment of chronic granulomatous disease.


Delaying time to disease progression in patients with severe, malignant osteopetrosis.


Treatment of epilepsy patients who cannot take anything by mouth (NPO)

For the diagnosis of neuroblastomas

For the diagnosis of pheochromocytomas


of 400



3142

ipilimumab Yervoy 6/3/20043143

ipilimumab Yervoy 6/3/20043144

iron(III)-hexacyanoferrate(II) Radiogardase 5/1/20033145

isavuconazonium sulfate Cresemba 5/6/20133146

isavuconazonium sulfate Cresemba 10/25/2013 Treatment of zygomycosis3147

ivacaftor Kalydeco 12/20/20063148

ixazomib citrate Ninlaro 2/18/2011 Treatment of multiple myeloma3149

Ixiaro 9/25/2012 Intercell AG3150

Lamotrigine Lamictal 8/23/19953151 Lanreotide Somatuline Depot 9/11/2000 Treatment for acromegly IPSEN, Inc.

Treatment of high risk Stage II, Stage III, and Stage IV melanoma


Treatment of high risk Stage II, Stage III, and Stage IV melanoma


Treatment of patients with known or suspected internal contamination with radioactive or non-radioactive cesium or thallium

Heyl Chemisch-Pharmzeutische Fabrik GMBH & Co, KG




Treatment of patients with cystic fibrosis

Vertex Pharmaceuticals, Inc.

Millennium Pharmaceuticals

Japanese encephalitis vaccine, inactivated, adsorbed

Prevention of Japanese encephalitis virus in pediatric patients.


Glaxo Wellcome Research and Development


of 400



3152

lanreotide acetate Somatuline Depot 8/25/20113153

laronidase Aldurazyme 9/24/19973154

lenalidomide Revlimid 4/27/2009 Celgene Corporation3155

lenalidomide Revlimid 1/29/2004 Celgene Corporation3156

lenalidomide Revlimid 9/20/2001 Treatment of multiple myeloma Celgene Corporation3157

lenalidomide Revlimid 9/20/2001 Treatment of multiple myeloma Celgene Corporation3158

lenvatinib Lenvima 12/27/2012 Eisai, Inc.3159

Lepirudin Refluden 2/13/19973160

Leucovorin Leucovorin Calcium 12/8/1986 Immunex Corporation3161

Leucovorin Leucovorin Calcium 8/17/1988 Immunex Corporation



Treatment of patients with mucopolysaccharidosis-I.




Treatment of follicullar, medullary, anaplastic, and metastatic or locally advanced papillary thyroid cancer

Treatment of heparin-associated thrombocytopenia type II.


For use in combination with 5-fluorouracil for the treatment of metastatic colorectal cancer.

For rescue use after high dose methotrexate therapy in the treatment of osteosarcoma.


of 400



3162

Leuprolide acetate Lupron Injection 7/25/19883163




Levodopa and carbidopa Duodopa 1/18/2000 AbbVie, Inc.3167

Levoleucovorin Fusilev 8/1/19913168

levoleucovorin Fusilev 12/18/19903169

Orlaam 1/24/1985


Tap Pharmaceuticals, Inc.

Treatment of primary and secondary carnitine deficiency of genetic origin.


Treatment of manifestations of carnitine deficiency in patients with end stage renal disease who require dialysis.


Treatment of genetic carnitine deficiency.


Treatment of late stage Parkinson's disease

For use in conjunction with high-dose methotrexate in the treatment of osteosarcoma.


For use in combination chemotherapy with the approved agent 5-fluorouracil in the palliative treatment of metastatic adenocarcinoma of the colon and rectum


Levomethadyl acetate hydrochloride

Treatment of heroin addicts suitable for maintenance on opiate agonists.

Biodevelopment Corporation


of 400



3170

Lidocaine patch 5% Lidoderm Patch 10/24/19953171

Liothyronine sodium injection Triostat 7/30/19903172

Liposomal amphotericin B Ambisome 12/6/1996 Fujisawa USA, Inc.3173

Liposomal amphotericin B Ambisome 12/10/1996 Fujisawa USA, Inc.3174

liposomal irinotecan n/a 7/21/2011 Treatment of pancreatic cancer3175

Lodoxamide tromethamine 10/16/19913176

lomitapide Juxtapid 10/23/20073177

lumacaftor/ivacaftor Orkambi 6/30/2014 Treatment of cystic fibrosis3178

lumacaftor/ivacaftor Orkambi 6/30/2014 Treatment of cystic fibrosis3179

macitentan Opsumit 9/3/2009

For relief of allodynia (painful hypersensitivity), and chronic pain in postherpetic neuralgia.

Teikoku Pharma USA, Inc.

Treatment of myxedema coma/precoma.


Treatment of visceral leishmaniasis.

Treatment of cryptococcal meningitis.


Alomide Ophthalmic Solution

Treatment of vernal keratoconjunctivitis.

Alcon Laboratories, Inc.








of 400



3180

Mafenide acetate solution Sulfamylon Solution 7/18/19903181

mebendazole 9/3/20143182

Mecasermin Increlex 12/12/19953183

mecasermin rinfabate Iplex 5/17/2002 Insmed, Inc.3184

meclorethamine Valchlor 8/17/2004 Treatment of mycosis fungoides

For use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Mylan Laboratories, Inc.

Vermox 500 Mg Chewable Tablets

Treatment of single or mixed gastrointestinal infestations by Trichuris trichiura (whipworm), Ascaris lumbricoides (large roundworm), and Ancylostoma duodenale and Nectar americanus (hookworm).

Janssen Pharmaceutical Research & Development, LLC

Treatment of growth hormone insensitivity syndrome.


Treatment of growth hormone insensitivity syndrome (GHIS)

Actelion Pharmaceuticals Ltd.


of 400



3185

mefloquine HCL Lariam 4/13/19883186

mefloquine HCL Lariam 4/13/19883187

Megestrol acetate Megace 4/13/19883188

meloxicam Mobic 11/22/20023189

Melphalan Alkeran For Injection 2/24/1992 Glaxo Wellcome Inc.

For use in the treatment of acute malaria due to Plasmodium falciparum and Plasmodium vivax, and for the prophylaxis of Plasmodium falciparum malaria which is resistant to other available drugs


For use in the treatment of acute malaria due to Plasmodium falciparum and Plasmodium vivax, and for the prophylaxis of Plasmodium falciparum malaria which is resistant to other available drugs


Treatment of patients with anorexia, cachexia, or significant weight loss (=/>10% of baseline body weight) and confirmed diagnosis of AIDS.




Treatment of patients with multiple myeloma for whom oral therapy is inappropriate.


of 400



3190

melphalan Evomela 11/24/20083191

mercaptopurine oral solution Purixan 8/20/20123192

Mesna Mesnex 11/14/1985 Degussa Corporation3193

Methotrexate sodium Methotrexate 10/21/1985 Lederle Laboratories3194

methylene blue0.5% Provayblue 12/18/2012 Provepharm SAS3195

metreleptin Myalept 8/22/20013196

Metronidazole (topical) Metrogel 10/22/1987 Treatment of acne rosacea.3197

Midodrine HCl Amatine 6/21/1985 Shire3198

mifepristone Korlym 7/5/20073199

miglustat Zavesca 5/29/1998 Treatment of Gaucher disease.

High dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation

Spectrum Pharmaceuticals, INc.

Treatment of acute lymphoblastic leukemia in pediatric patients

Nova Laboratories Limited

For use as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis.

Treatment of osteogenic sarcoma.

Treatment of hereditary and acquired methemoglobinemia

Treatment of metabolic disorders secondary to lipodystrophy


Galderma Laboratories, Inc.

Treatment of patients with symptomatic orthostatic hypotension.

Treatment of the clinical manifestations of endogenous Cushing's syndrone

Corcept Therapeutics, Inc.



of 400



3200miltefosine Impavido 10/10/2006 Treatment of leishmaniasis.

3201

mipomersen Kynamro 5/23/20063202

mitomycin-C Mitosol 1/8/20083203

Mitoxantrone Novantrone 8/13/1999 Serono, Inc.3204

Mitoxantrone Novantrone 8/13/1999 Serono, Inc.3205

Mitoxantrone Novantrone 8/21/1996 Serono3206

Mitoxantrone HCl Novantrone 7/13/1987 Lederle Laboratories3207

Modafinil Provigil 3/15/1993 Cephalon, Inc.3208

Monooctanoin Moctanin 5/30/19843209

Infumorph 7/12/1990 Elkins-Sinn, Inc.

Knight Therapeutics (USA)


Kastle Therapeutics, LLC

Treatment of refractory glaucoma as an adjunct to ab externo glaucoma surgery.


Treatment of secondary-progressive multiple sclerosis.

Treatment of progressive-relapsing multiple sclerosis.

Treatment of hormone refractory prostate cancer.

Treatment of acute myelogenous leukemia, also referred to as acute nonlymphocytic leukemia.

Treatment of excessive daytime sleepiness in narcolepsy.

For dissolution of cholesterol gallstones retained in the common bile duct.

Ethitek Pharmaceuticals, Inc.

Morphine sulfate concentrate (preservative free)

For use in microinfusion devices for intraspinal administration in the treatment of intractable chronic pain.


of 400



3210

M.V.I.-12 3/8/20043211

Naglazyme 2/17/19993212

Nafarelin acetate Synarel Nasal Solution 7/20/1988 Syntex (USA), Inc.3213

Naltrexone HCl Trexan 3/11/19853214

necitumumab n/a 11/20/2015 Eli Lilly and Company3215

nelarabine Arranon 8/10/20043216

nilotinib Tasigna 4/27/2006

multi-vitamin infusion without vitamin K

Prevention of vitamin deficiency and thromboembolic complications in people receiving home parenteral nutrition and warfarin-type anticoagulant therapy

Mayne Pharma (USA) Inc.

N-acetylgalactosamine-4-sulfatase, recombinant human

Treatment of mucopolysaccharidosis Type VI (Maroteaux-Lamy syndrome).



For blockade of the pharmacological effects of exogenously administered opioids as an adjunct to the maintenance of the opioid-free state in detoxified formerly opioid-dependent individuals.

DuPont Pharmaceuticals

Treatment of squamous non-small cell lung cancer

Treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma





of 400



3217

nimodipine Nymalize 9/16/20113218

nintedanib Ofev 6/29/20113219

nitazoxanide Alinia 2/14/2002 Treatment of intestinal giardiasis3220

Nitazoxanide Alinia 12/12/1996 Treatment of cryptosporidiosis.3221

Nitisinone Orfadin 5/16/1995 Treatment of tyrosinemia type 1.3222

Nitisinone Orfadin 5/16/1995 Treatment of tyrosinemia type 1.3223

Nitric oxide Inomax 6/22/1993 INO Therapeutics, Inc.3224

nivolumab n/a 1/23/20133225

nivolumab Opdivo 8/7/2014 Treatment of Hodgkin lymphoma3226

obeticholic acid Ocaliva 4/9/20083227

obiltoxaximab Anthim 6/9/20063228

obinutuzumab Gazyva 4/15/2015 Genentech, Inc.3229

obinutuzumab Gazyva 2/17/2012 Genentech, Inc.

Treatment of subarachnoid hemorrhage.

Arbor Pharmaceuticals, Inc.

Treatment of patients with idiopathic pulmonary fibrosis.






Treatment of persistent pulmonary hypertension in the newborn.

Treatment of Stage IIb to IV melanoma




Intercept Pharmaceuticals, Inc.

Treatment of exposure to B. anthracis spores

Elusys Therapeutics, Inc.




of 400



3230

Octreotide Sandostatin Lar 8/24/19983231

Octreotide Sandostatin Lar 8/24/19983232

Octreotide Sandostatin Lar 8/24/1998 Treatment of acromegaly.3233

ofatumumab Arzerra 3/10/20093234




Ofloxacin 4/18/1991 Allergan, Inc.3238

olaparib Lynparza 10/16/2013 Treatment of ovarian cancer3239

olaratumab Lartruvo 10/9/2014 Treatment of soft tissue sarcoma Eli Lilly and Company3240

omacetaxine mepesuccinate Synribo 3/10/2006

Treatment of severe diarrhea and flushing associated with malignant carcinoid tumors.


Treatment of diarrhea associated with vasoactive intestinal peptide tumors (VIPoma).











Ocuflox Ophthalmic Solution

Treatment of bacterial corneal ulcers.



IVAX International GmbH


of 400



3241

Oprelvekin Neumega 12/17/19963242

osimertinib Tagrisso 9/4/20143243

oxybate Xyrem 11/7/1994 Treatment of narcolepsy. Jazz Pharmaceuticals3244

oxybate Xyrem 11/7/1994 Treatment of narcolepsy. Jazz Pharmaceuticals3245

Paclitaxel Taxol 3/25/19973246

Abraxane 9/3/2009 Treatment of pancreatic cancer.3247

panobinostat Farydak 8/20/2012 Treatment of multiple myeloma3248

parathyroid hormone Natpara 8/31/20073249

paricalcitol Zemplar 10/27/2015 Abbvie, inc.3250

pasireotide n/a 8/25/2009 Treatment of acromegaly3251

pasireotide Signifor 7/24/2009 Treatment of Cushing's disease

Prevention of severe chemotherapy-induced thrombocytopenia.


Treatment of epidermal growth factor receptor mutation-positive non-small cell lung cancer




paclitaxel protein-bound particles

Abraxis BioScience, LLC



Shire-NPS Pharmaceuticals, Inc.

Treatment of pediatric hyperparathyroidism




of 400



3252

pazopanib Votrient 10/20/20093253

Pegademase bovine Adagen 5/29/19843254

Pegaspargase Oncaspar 10/20/1989 Baxalta US, Inc.3255

Pegfilgrastim Neulasta 11/20/2013 Amgen, Inc.3256

peginterferon alfa-2b Sylatron 4/9/20083257

pegloticase Krystexxa 2/21/20013258

Pegvisomant Somavert 6/24/1997 Treatment of acromegaly. Sensus Corporation3259




For enzyme replacement therapy for ADA deficiency in patients with severe combined immunodeficiency.

Sigma-tau Pharmaceuticals, Inc.

Treatment of acute lymphocytic leukemia.

Treatment of subjects at risk of developing myelosuppression after a radiological or nuclear incident

Treatment of malignant melanoma stages IIb through IV.

Schering-Plough Corporation

To control the clinical consequences of hyperuricemia in patients with severe gout in whom conventional therapy is contraindicated or has been ineffective.

Horizon Pharma Rheumatology, LLC




of 400



3260


pemetrexed disodium Alimta 8/28/2001 Eli Lilly and Company3262

Pentamidine isethionate Nebupent 1/12/1988 Fujisawa USA, Inc.3263

Pentamidine isethionate Pentam 300 2/28/1984 Fujisawa USA, Inc.3264

Pentastarch Pentaspan 8/28/19853265

Pentosan polysulfate sodium Elmiron 8/7/1985 Treatment of interstitial cystitis. Alza Corporation3266

Pentostatin for injection Nipent 9/10/1987 Treatment of hairy cell leukemia. SuperGen, Inc.3267

phoxilium n/a 2/14/20143268

Pilocarpine Salagen 9/24/1990 MGI Pharma, Inc.3269

Pilocarpine HCl Salagen 2/28/1992 MGI Pharma, Inc.



Treatment of malignant pleural mesothelioma

Prevention of Pneumocystis carinii pneumonia in patients at high risk of developing this disease.

Treatment of Pneumocystis carinii pneumonia.

As an adjunct in leukapheresis to improve the harvesting and increase the yield of leukocytes by centrifugal means.

DuPont Pharmaceuticals

For use as a replacement solution in patients undergoing continuous renal replacement therapy

Gambro Renal Products, Inc.

Treatment of xerostomia induced by radiation therapy for head and neck cancer.

Treatment of xerostomia and keratoconjunctivitis sicca in Sjogren's syndrome patients.


of 400



3270pirfenidone Esbriet 3/5/2004 Genentech

3271

plerixafor Mozobil (R) 7/10/2003 Genzyme Corporation3272

Gliadel 12/13/1989 Treatment of malignant glioma.3273

Gliadel 12/13/1989 Treatment of malignant glioma.3274

pomalidomide Pomalyst 1/15/2003 Treatment of multiple myeloma Celgene Corporation3275

ponatinib Iclusig 11/20/20093276

ponatinib Iclusig 11/20/20093277

porfimer Photofrin 10/19/2001


For use to improve the yield of progentor cells in the apheresis product for subsequest stem cell transplantation following myelosuppressive or myeloablative chemotherapy

polifeprosan 20 with carmustine

Guilford Pharmaceuticals, Inc.

polifeprosan 20 with carmustine

Guilford Pharmaceuticals, Inc.

Treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL)

ARIAD Pharmaceuticals Inc.


ARIAD Pharmaceuticals Inc.

For the ablation of High-Grade Dysplasia in Barrett's Esophagus in patients who are not considered to be candidates for esophagectomy

Axcan Scandipharm Inc.


of 400



3278


Potassium citrate Urocit-K 11/1/19843280

Potassium citrate Urocit-K 11/1/19843281

Potassium Iodide Oral Solution Thyroshield 11/17/20043282

pralatrexate Folotyn 7/20/2006 Treatment of T-cell lymphoma3283

propranolol Hemangeol 9/5/20083284

Protein C concentrate Ceprotin 6/23/1992 Baxalta US, Inc.

For the photodynamic therapy of patients with primary or recurrent obstructing (either partially or completely) esophageal carcinoma.

QLT Phototherapeutics, Inc.

Prevention of uric acid nephrolithiasis.

University of Texas Health Science Center at Dallas

1. Prevention of calcium renal stones in patients with hypocitraturia 2. For avoidance of the complication of calcium stone formation in patients with uric lithiasis.

University of Texas Health Science Center at Dallas

For use as a thyroid blocking agent in pediatric patients exposed to radiactive iodine

Fleming & Company, Pharmaceuticals


Treatment of proliferating infantile hemangiomas requiring systemic therapy

Pierre Fabre Dermatologie

For replacement therapy in congenital protein C deficiency for the prevention and treatment of thrombosis, pulmonary emboli, and purpura fulminans.


of 400



3285

Kcentra 12/27/2012 CSL Behring3286

Kcentra 12/27/2012 CSL Behring3287

Curosurf 8/2/1993 Chiesi USA, Inc.3288

quinine Sulfate n/a 6/3/2004 Treatment of malaria3289

raloxifene Evista 7/14/2005 Eli Lilly and Company3290

ramucirumab Cyramza 2/16/2012 Treatment of gastric cancer Eli Lilly and Company3291

ramucirumab Cyramza 2/16/2012 Treatment of gastric cancer Eli Lilly and Company3292

rasburicase Elitek 10/11/20003293

raxibacumab Abthraxtm 11/12/2003 Treatment of anthrax

prothrombin complex concentrate (human)

Treatment of patients needing urgent reversal of Vitamin K antagonist therapy for treatment of major bleeding and/or surgical procedures

prothrombin complex concentrate (human)

Treatment of patients needing urgent reversal of Vitamin K antagonist therapy for treatment of major bleeding and/or surgical procedures

Pulmonary surfactant replacement, porcine

For the treatment and prevention of respiratory distress syndrome in premature infants.

AR Holding Company, Inc.

Reduction of the risk of breast cancer in postmenopausal women

Treatment of malignancy-associated or chemotherapy-induced hyperuricemia.

Sanofi-Synthelabo Research

Human Genome Sciences, Inc.


of 400



3294

Idelvion 4/27/2012 CSL Behring, LLC3295

1. Myozyme 2. Lumizyme 8/19/1997 Genzyme Corporation3296



Atryn 12/7/20073299

Luveris 10/7/1994 EMD Serono, Inc.3300

n/a 11/23/2010 Baxalta US, Inc.

recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)

Treatment of patients with congenital factor IX deficiency (hemophilia B).

Recombinant human acid alpha-glucosidase; alglucosidase alfa

Treatment of glycogen storage disease type II.





recombinant human antithrombin

Treatment of congenital antithrombin deficiency to prevent the occurrence of serious, potentially life-threatening venous thromboembolisms which may develop as a result of surgical or obstetrical procedures

GTC Biotherapeutics, Inc.

Recombinant human luteinizing hormone

For use in association with recombinant human follicle stimulating hormone for the treatment of women with chronic anovulation due to hypogonadotropic hypogonadism.

recombinant von Willebrand factor (rhVWF)

Treatment of von Willebrand disease.


of 400



3301

regorafenib Stivarga 1/12/20113302

H.P. Acthar Gel 5/21/2003 Treatment of infantile spasms3303

Respigam 9/27/19903304

Winrho Sd 11/9/19933305

ribavirin Rebetol 4/4/2003 Schering Corporation3306

Photrexa Viscous 9/2/2011 Treatment of keratoconus Avedro, Inc.3307

Photrexa Viscous 12/2/2011 Avedro, Inc.3308

Rifabutin Mycobutin 12/18/19893309

Rifampin Rifadin I.V. 12/9/1985

Treatment gastrointestinal stromal tumors


repository corticotropin or adrenocorticotropic hormone

Questcor Pharmaceuticals, Inc.

Respiratory syncytial virus immune globulin (Human)

Prophylaxis of respiratory syncytial virus lower respiratory tract infections in infants and young children at high risk of RSV disease.

MedImmune & Massachussetts Public Health Biologics Labs.

Rho (D) immune globulin intravenous (human)


Rh Pharmaceuticals, Inc.

Treatment of chronic hepatitis C in pediatric patients

riboflavin ophthalmic solution & ultraviolet A

riboflavin ophthalmic solution ultraviolet-A (UVA) irradiation

Treatment of corneal ectasia following refractive surgery

Prevention of disseminated Mycobacterium avium complex disease in patients with advanced HIV infection.

Adria Laboratories, Inc.

For antituberculosis treatment where use of the oral form of the drug is not feasible.



of 400



3310Rifater 9/12/1985

3311Rifapentine Priftin 6/9/1995

3312

rifaximin Normix 2/10/19983313

Rilonacept Arcalyst 12/20/20043314

Riluzole Rilutek 3/16/19933315

riociguat Adempas 9/19/20133316

riociguat Adempas 9/19/20133317



rituximab Rituxan 2/14/2006 Genentech, Inc.

Rifampin, isoniazid, pyrazinamide

For the short-course treatment of tuberculosis.




Treatment of hepatic encephalopathy

Salix Pharmaceuticals, Inc.

Treatment of CIAS1-Associated Periodic Syndromes




Treatment of chronic thromboembolic pulmonary hypertension





Treatment of non-Hodgkin's B-cell lymphoma

Treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (Wegener's Granulomatosis, Microscopic Polyangiitis, and Churg-Strauss Syndrome)


of 400



3320romidepsin Istodax 9/30/2004 Celgene Corporation

3321romidepsin Istodax 9/30/2004 Celgene Corporation

3322romiplostim Nplate 3/27/2003 Amgen, Inc.

3323

rosuvastatin Crestor 2/14/20143324

rufinamide Banzel 10/8/2004 Eisai, Inc.3325

ruxolitinib Jakafi 3/26/2010 Treatment of polycythemia vera Incyte Corporation3326 ruxolitinib phosphate Jakafi 9/5/2008 Treatment of myelofibrosis Incyte Corporation3327

Sacrosidase Sucraid 12/10/1993 QOL Medical, LLC3328

sapropterin Kuvan 1/29/20043329

Sargramostim Leukine 3/6/1995 Immunex Corporation

Treatment of non-Hodgkin T-cell lymphomas

Treatment of non-Hodgkin T-cell lymphomas


For the treatment of pediatric homozygous familial hypercholesterolemia

iPR Pharmaceuticals, Inc.

Treatment of Lennox-Gastaut Syndrome.

Treatment of congenital sucrase-isomaltase deficiency



To reduce neutropenia and leukopenia and decrease the incidence of death due to infection in patients with acute myelogenous leukemia.


of 400



3330

Sargramostim Leukine 5/3/1990 Immunex Corporation3331

Satumomab pendetide Oncoscint Cr/Ov 9/25/1989 Detection of ovarian carcinoma. Cytogen Corporation3332

sebelipase alfa Kanuma 7/1/20103333

Selegiline HCl Eldepryl 11/7/19843334

selexipag Uptravi 4/30/2010 Actelion Ltd3335

Sermorelin acetate Geref 9/14/1988 EMD Serono, Inc.3336

siltuximab Sylvant 5/26/2006 Janssen Biotech, Inc.3337

sirolimus Rapamune 10/31/2012 Pfizer, Inc.3338

Nithiodote 4/9/2008

Treatment of neutropenia associated with bone marrow transplant, for the treatment of graft failure and delay of engraftment, and for the promotion of early engraftment.

Treatment of lysosomal acid lipase deficiency

Alexion Pharmaceuticals

As an adjuvant to levodopa and carbidopa treatment of idiopathic Parkinson's disease (paralysis agitans), postencephalitic Parkinsonism, and symptomatic Parkinsonism.

Somerset Pharmaceuticals, Inc.


Treatment of idiopathic or organic growth hormone deficiency in children with growth failure.

Treatment of Castleman's disease


sodium nitrite and sodium thiosulfate

Treatment of known or suspected cyanide poisoning



of 400



3339

sodium phenylbutyrate Buphenyl 11/22/19933340

Somatrem for injection Protropin 12/9/1985 Genentech, Inc.3341

Somatropin Norditropin 8/9/2006 Novo Nordisk Inc.3342

Somatropin Nutropin 3/6/1987 Genentech, Inc.3343

Somatropin Genotropin 9/6/1994 Pharmacia & Upjohn3344

Somatropin Humatrope 5/8/1990 Eli Lilly and Company

Treatment of urea cycle disorders: carbamylphosphate synthetase deficiency, ornithine transcarbamylase deficiency, and arginiosuccinic acid synthetase deficiency.


1. Long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion (prevalence 15,000) 2. Treatment of short stature associated with Turner's syndrome (prevalence 8000).

Treatment of short stature in patients with Noonan syndrome

For use in the long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion.

Treatment of adults with growth hormone deficiency.

Treatment of short stature associated with Turner syndrome.


of 400



3345

Somatropin Humatrope 12/15/2005 Eli Lilly and Company3346

Somatropin (r-DNA) Zorbtive 3/6/1995 EMD Serono, Inc.3347

Somatropin (rDNA origin) Saizen 3/6/1987 EMD Serono, Inc.3348

Somatropin (rDNA origin) Nutropin Depot 10/28/1999 Genentech, Inc.3349

Norditropin 7/10/19873350

Somatropin for injection Nutropin 11/18/1996 Genentech, Inc.3351

Somatropin for injection Serostim 11/15/1991 EMD Serono, Inc.

Treatment of short stature in pediatric patients with short stature homeobox-containing gene (SHOX) deficiency

For use alone or in combination with glutamine in the treatment of short bowel syndrome.

Treatment of idiopathic or organic growth hormone deficiency in children with growth failure.

Long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion.

Somatropin (rDNA origin) injection

1. Treatment of growth failure in children due to inadequate growth hormone secretion 2. Treatment of short stature associated with Turner's syndrome

Novo Nordisk Pharmaceuticals

As replacement therapy for growth hormone deficiency in adults after epiphyseal closure.

Treatment of AIDS-associated catabolism/weight loss.


of 400



3352


Somatropin for injection Humatrope 6/12/1986 Eli Lilly and Company3354


Somatropin [rDNA] Genotropin 7/6/1999 Pharmacia & Upjohn3356

somatropin [rDNA] Genotropin 12/27/20003357

Sorafenib Nexavar 10/8/20043358

sorafenib Nexavar 12/12/20113359

Sorafenib Nexavar 4/20/2006

Treatment of growth retardation associated with chronic renal failure.

For the long-term treatment of children who have growth failure due to inadequate secretion of normal endogenous growth hormone.

Treatment of short stature associated with Turner's syndrome.

Treatment of short stature in patients with Prader-Willi syndrome.

Treatment of growth failure in children who were born small for gestational age.

Pharmacia and Upjohn Company


Bayer Pharmaceutical Corporation

Treatment of medullary thyroid cancer, anaplastic thyroid cancer, and recurrent or metastatic follicular or papillary thyroid cancer



Bayer Pharmaceuticals Corporation


of 400



3360

sotalol (IV) So-Aqueous 7/25/20083361

Sotalol HCl Betapace 9/23/19883362

Sterile talc powder 9/18/1995 Bryan Corporation3363

Succimer Chemet Capsules 5/9/19843364

Sulfadiazine n/a 3/14/19943365

Synthetic human secretin Chirostim 6/16/1999 ChiRhoClin, Inc.3366

Synthetic porcine secretin Secreflo 6/18/1999 ChiRhoClin, Inc.3367

Synthetic porcine secretin Secreflo 6/18/1999 ChiRhoClin, Inc.

For ventricular tachycardia, ventricular fibrillation, or the maintenance of sinus rhythm in patients converted from atrial fibrillation or atrial flutter when oral administration is not possible.

Academic Pharmaceuticals

1. Treatment of life-threatening ventricular tachyarrhythmias 2. Prevention of life treatening ventricular tachyarrhythmias


Sclerosol Intrapleural Aerosol


Treatment of lead poisoning in children.

Bock Pharmacal Company

For use in combination with pyrimethamine for the treatment of Toxoplasma gondii encephalitis in patients with and without AIDS.

Eon Labs Manufacturing, Inc.

For use in the diagnosis of gastrinoma associated with Zollinger-Ellison syndrome.

For use in the evaluation of exocrine pancreas function.

For use in the diagnosis of gastrinoma associated with Zollinger-Ellison syndrome.


of 400



3368

Synthetic porcine secretin Secreflo 3/7/2000 ChiRhoClin, Inc.3369

tacrolimus Envarsus Xr 12/20/20133370

Tacrolimus Prograf 6/6/20053371

tadalafil Adcirca 12/18/2006 Eli Lilly and Company3372

Taliglucerase alfa Elelyso For Injection 9/3/2009 Treatment of Gaucher's disease Pfizer, Inc.3373

talimogene laherparepvec Imlygic 3/14/20113374

tasimelteon Hetlioz 1/19/20103375

Lymphoseek 9/17/2014

For use in conjunction with diagnostic, therapeutic, or combined diagnostic/therapeutic procedures for pancreatic disorders to increase pancreatic fluid secretion.

Prophylaxis of organ rejection in patients receiving allogeneic kidney transplant

Veloxis Pharmaceuticals, Inc.

Prophylaxis of organ rejection in patients receiving heart transplants.

Astellas Pharma US, Inc.


Treatment of stage IIb-stage IV melanoma

BioVex, Inc. (subsidiary of Amgen)

Non-24-hour sleepwake disorder in blind individuals without light perception

Vanda Pharmaceuticals, Inc.

technetium Tc 99m tilmanocept

Use in sentinel lymph node detection (SLN) with a hand-held gamma-counter, with scintigraphic imaging, in patients with cancer of the head and neck

Navidea Biopharmaceuticals


of 400



3376

3/17/2009 Pharmalucence, Inc.3377

teduglutide [rDNA origin] Gattex 6/29/20003378

temozolomide Temodar 10/5/19983379

temozolomide Temodar 10/5/19983380

Temsirolimus Torisel 12/16/20043381

Teniposide Vumon For Injection 11/1/19843382

tenofovir Viread 3/17/2009 Gilead Sciences, Inc.3383

Teriparatide Parathar 1/9/19873384

Tetrabenazine Xenazine 12/11/1997

Technetium Tc99m sulfur colloid injection, lyophilized

Technetium Tc99m Sulfur Colloi

For localization of sentinel lymph nodes in patients with melanoma.

Treatment of short bowel syndrome.

NPS Pharmaceuticals, Inc.

Treatment of recurrent malignant glioma.


Treatment of recurrent malignant glioma.




Treatment of refractory childhood acute lymphocytic leukemia.


Treatment of pediatric HIV infection.

Diagnostic agent to assist in establishing the diagnosis in patients presenting with clinical and laboratory evidence of hypocalcemia due to either hypoparathyroidism or pseudohypoparathyroidism.



Prestwick Pharmaceuticals, Inc


of 400



3385Thalidomide Thalomid 7/26/1995 Celgene Corporation

3386Thalidomide Thalomid 10/14/1998 Treatment of multiple myeloma Celgene Corporation

3387

Thyrotropin alfa Thyrogen 8/3/2001 Genzyme Corporation3388

Thyrotropin alpha Thyrogen 2/24/1992 Genzyme Corporation3389

tinidazole Tindamax 4/18/2002 Treatment of giardiasis3390

Tinidazole Tindamax 8/20/2003 Treatment of amebiasis3391

Tiopronin Thiola 1/17/1986 Pak, Charles Y.C. M.D.3392

Tobramycin for inhalation Tobi 10/13/19943393

tocilizumab Actemra 7/31/2012 Genentech, Inc.3394

Topiramate Topamax 11/25/1992

Treatment of erythema nodosum leprosum.

Treatment of well-differentiated papillary, follicular or combined papillary/follicular carcinomas of the thyroid

As an adjunct in the diagnosis of thyroid cancer.

Presutti Laboratories, Inc.

Presutti Laboratories, Inc.

Prevention of cystine nephrolithiasis in patients with homozygous cystinuria.

Treatment of bronchopulmonary infections of Pseudomonas aeruginosa in cystic fibrosis patients.


Treatment of pediatric patients (age 16 years and younger) with polyarticular-course juvenile idiopathic arthritis


Johnson & Johnson Pharmaceutical R & D, LLC


of 400



3395

Toremifene Fareston 9/19/1991 Orion Corporation3396

Bexxar 5/16/1994 GlaxoSmithKline LLC3397

trabectedin Yondelis 9/30/2004 Treatment of soft tissue sarcoma3398

trametinib Mekinist 12/20/20103399

trametinib and dabrafenib Mekinist And Tafinlar 9/20/20123400

trametinib and dabrafenib Mekinist And Tafinlar 9/20/20123401

trastuzumab Herceptin 10/13/2009 Genentech, Inc.3402

treprostinil Remodulin 6/4/19973403

treprostinil (inhalational) Tyvaso 6/17/2010 LungRx, Inc.3404

Tretinoin Vesanoid 10/24/1990

Hormonal therapy of metastatic carcinoma of the breast.

Tositumomab and iodine I 131 tositumomab

Treatment of non-Hodgkin's B-cell lymphoma.


Treatment of Stage IIb through Stage IV melanoma


Treatment of Stage IIb through IV melanoma.


Treatment of Stage IIb through IV melanoma.


Treatment of HER2-overexpressing advanced adenocarcinoma of the stomach, including gastroesophageal junction


United Therapeutics Corp.





of 400



3405

Trientine HCl Syprine 12/24/19843406

Trimetrexate glucuronate Neutrexin 5/15/19863407

Trypan blue Membraneblue 8/2/20063408



Urofollitropin Metrodin 11/25/1987 EMD Serono, Inc.3411

Ursodiol Urso 250 6/20/19913412

n/a 6/18/20043413

Cnj-016 6/18/2004 Cangene Corporation

Treatment of patients with Wilson's disease who are intolerant, or inadequately responsive to penicillamine.

Merck Sharp & Dohme Research

Treatment of Pneumocystis carinii pneumonia in AIDS patients.


Selectively staining epiretinal membranes during ophthalmic surgical vitrectomy procedures

Dutch Ophthalmic Research Center Int'l BV

An antidote in the treatment of 5-fluorouracil or capecitabine poisoning

Wellstat Therapeutics Corp.

Treatment of hereditary orotic aciduria

Wellstat Therapeutics, Inc.

For induction of ovulation in patients with polycystic ovarian disease who have an elevated LH/FSH ratio and who have failed to respond to adequate clomiphene citrate therapy.

Treatment of patients with primary biliary cirrhosis


Vaccinia Immune Globulin (Human) Intravenous

Treatment of severe complications from the smallpox vaccine

DynPort Vaccine Company LLC

Vaccinia Immune Globulin (Human) Intravenous

Treatment of complications of vaccinia vaccination


of 400



3414

Valrubicin Valstar 5/23/19943415

vandetanib Caprelsa(R) 10/21/2005 Genzyme Corporation3416

Varizig 11/7/20063417

velaglucerase-alfa Vpriv 6/8/2009 Treatment of Gaucher disease3418

vemurafenib Zelboraf 12/20/20103419

venetoclax Venclexta 9/20/2012 AbbVie, Inc3420

vigabatrin Sabril 6/12/2000 Treatment of infantile spasms. H. Lundbeck A/S3421

Marqibo 1/8/20073422

vorinostat Zolinza 3/16/2004 Merck & Co., Inc.

Treatment of carcinoma in situ of the urinary bladder.

Anthra Pharmaceuticals, Inc.

Treatment of patients with follicular thyroid carcinoma, medullary thyroid carcinoma, anaplastic thyroid carcinoma, and locally advanced and metastatic papillary thyroid carcinoma

Varicella Zoster Immune Globulin (Human)

Passive immunization for the treatment of exposed, susceptible individuals who are at risk of complications from varicella

Cangene bioPharma, Inc.

Shire Human Genetics Therapies, Inc.

Treatment of patients with IIb to Stage IV melanoma positive for the BRAF(v600) mutation



vinCRIStine sulfate LIPOSOME injection


Talon Therapeutics, Inc.



of 400



3423Zalcitabine Hivid 6/28/1988 Treatment of AIDS.

3424zidovudine Retrovir 7/17/1985 Treatment of AIDS Glaxo Wellcome Inc.

3425Zinc acetate Galzin 11/6/1985 Treatment of Wilson's disease. Lemmon Company

3426

Zoledronate Zometa, Zabel 8/18/2000


Treatment of tumor induced hypercalcemia.


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