2018 FDA Approvals Summary - pharmacircle.com...TESTOSTERONE ENANTHATE SUUTANEOUS SOLUTION ANTARES...

2018 FDA Approvals Summary

BLA, NDA, & Tentative Approvals

Key Drug-Device Supplements

PharmaCircle LLC

2019-01-14

Application Number

Product Name Molecule/API Name Route Dosage Form Company Name Approval

Date Marketing

Status Application

Category Indication

FDA Drugs Division - 2018 BLA Approvals (351(a) Biologics)

125294 GRANIX TBO-FILGRASTIM INJECTION INJECTABLE RATIOPHARM 2018-07-31 RX 351(a) Neutropenia

761051 POTELIGEO MOGAMULIZUMAB-KPKC INJECTION INJECTABLE KYOWA KIRIN 2018-08-08 RX 351(a) Mycosis Fungoides

761063 EMGALITY GALCANEZUMAB-GNLM INJECTION INJECTABLE ELI LILLY 2018-09-27 RX 351(a) Migraine

761065 TROGARZO IBALIZUMAB-UIYK INJECTION INJECTABLE TAIMED 2018-03-06 RX 351(a) Infections, HIV/AIDS, Other

761067 ILUMYA TILDRAKIZUMAB-ASMN INJECTION INJECTABLE SUN GLOBAL 2018-03-20 RX 351(a) Psoriasis, Other

761068 CRYSVITA BUROSUMAB-TWZA INJECTION INJECTABLE ULTRAGENYX 2018-04-17 RX 351(a) X-Linked Hypophosphatemia

761077 AIMOVIG ERENUMAB-AOOE INJECTION INJECTABLE AMGEN 2018-05-17 RX 351(a) Migraine

761079 PALYNZIQ PEGVALIASE-PQPZ INJECTION INJECTABLE BIOMARIN 2018-05-24 RX 351(a) Phenylketonuria

761089 AJOVY FREMANEZUMAB-VFRM INJECTION INJECTABLE TEVA 2018-09-14 RX 351(a) Migraine

761090 TAKHZYRO LANADELUMAB (SHP643) INJECTION INJECTABLE DYAX 2018-08-23 RX 351(a) Angioedema, Hereditary, Other

761092 REVCOVI ELAPEGADEMASE-LVLR INJECTION INJECTABLE LEADIANT 2018-10-05 RX 351(a) SCID, Other

761094 OXERVATE CENEGERMIN-BKBJ OPHTHALMIC SOLUTION DOMPE 2018-08-22 RX 351(a) Eye Diseases, Corneal

761097 LIBTAYO CEMIPLIMAB-RWLC INTRAVENOUS INJECTABLE REGENERON 2018-09-28 RX 351(a) Cancer, SCC

761102 ASPARLAS CALASPARGASE PEGOL-MKNL

INTRAVENOUS INJECTABLE SERVIER 2018-12-20 RX 351(a) Cancer, ALL

761104 LUMOXITI MOXETUMOMAB PASUDOTOX-TDFK

INJECTION INJECTABLE ASTRAZENECA 2018-09-13 RX 351(a) Cancer, HCL

761107 GAMIFANT EMAPALUMAB-LZSG INJECTION INJECTABLE NOVIMMUNE 2018-11-20 RX 351(a) Blood Cell Disorders, Other

761108 ULTOMIRIS RAVULIZUMAB-CWVZ INJECTION INJECTABLE ALEXION 2018-12-21 RX 351(a) PNH

761116 ELZONRIS TAGRAXOFUSP-ERZS INJECTION SOLUTION STEMLINE 2018-12-21 RX 351(a) Cancer, BPDCN

All Rights Reserved - PharmaCircle LLC (2019)

FDA Drugs Division - 2018 BLA Approvals (351(k) Biologics)

Application Number

Product Name Molecule/API Name Route Dosage Form Company Name Approval

Date Marketing

Status Application

Category Indication

125545 RETACRIT EPOETIN ALFA-EPBX INJECTION INJECTABLE HOSPIRA 2018-05-15 RX 351(k) Anemia, Cancer/Chemo-Induced

761039 UDENYCA PEGFILGRASTIM-CBQV INJECTION INJECTABLE COHERUS 2018-11-02 RX 351(k) Neutropenia

761075 FULPHILA PEGFILGRASTIM-JMDB INJECTION INJECTABLE MYLAN 2018-06-04 RX 351(k) Neutropenia

761080 NIVESTYM FILGRASTIM-AAFI INJECTION INJECTABLE HOSPIRA 2018-07-20 RX 351(k) Neutropenia

761071 HYRIMOZ ADALIMUMAB-ADAZ INJECTION INJECTABLE SANDOZ 2018-10-30 RX 351(k) Psoriasis, Other

761088 TRUXIMA RITUXIMAB-ABBS INJECTION INJECTABLE CELLTRION 2018-11-28 RX 351(k) Cancer, NHL, Other

761091 HERZUMA TRASTUZUMAB-PKRB INJECTION INJECTABLE CELLTRION 2018-12-14 RX 351(k) Cancer, Breast, Other


FDA Vaccines, Blood & Biologics Division - 2018 BLA Approvals (351(a) Biologics)

Application Number

Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Marketing

Status Application

Category Indication

125586 ANDEXXA ANDEXANET ALFA INJECTION INJECTABLE PORTOLA 2018-05-03 RX 351(a) Hemostasis

125563 VAXELIS VAXELIS INJECTION INJECTABLE SANOFI

PASTEUR 2018-12-26 RX 351(a)

Infections, Diphtheria, Pertus-sis, Poliomyelitis, Haemophilus, Hepatitis B, Tetanus

125587 PANZYGA IMMUNOGLOBULIN G, HU-

MAN PLASMA-DERIVED INJECTION INJECTABLE OCTAPHARMA 2018-08-02 RX 351(a)

Primary humoral immunodefi-ciency, Chronic immune thrombocytopenic purpura

125644 ALBUMINEX SERUM ALBUMIN, HUMAN INJECTION INJECTABLE BIO PRODUCTS LABORATORY

2018-06-19 RX 351(a) Hypovolemia, ascites, hypoalbuminemia

125661 JIVI DAMOCTOCOG ALFA PEGOL INJECTION INJECTABLE BAYER 2018-08-29 RX 351(a) Hemophilia A


FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 1 (New Molecular Entity) (1/2)

Application Number


Status Application

Category Indication

206709 DIACOMIT STIRIPENTOL ORAL CAPSULE BIOCODEX 2018-08-20 RX Type 1 Myoclonic Seizure

207078 LOKELMA SODIUM ZIRCONIUM

CYCLOSILICATE ORAL FOR SUSPENSION ASTRAZENECA 2018-05-18 RX Type 1 Hyperkalemia

207924 OLUMIANT BARICITINIB ORAL TABLET ELI LILLY 2018-05-31 RX Type 1 Rheumatoid Arthritis,

208078 FIRDAPSE AMIFAMPRIDINE

PHOSPHATE ORAL TABLET CATALYST 2018-11-28 RX Type 1

Lambert Eaton Myasthenic Syndrome

208623 GALAFOLD MIGALASTAT

HYDROCHLORIDE ORAL CAPSULE AMICUS 2018-08-10 RX Type 1 Fabry Disease

208627 TPOXX TECOVIRIMAT ORAL CAPSULE SIGA TECHNO. 2018-07-13 RX Type 1 Infections, Smallpox

208700 LUTATHERA LUTETIUM DOTATATE LU-177 INTRAVENOUS SOLUTION AAA USA 2018-01-26 RX Type 1 Cancer, Neuroendocrine

209229 LUCEMYRA LOFEXIDINE

HYDROCHLORIDE ORAL TABLET

US WORLDMEDS

2018-05-16 RX Type 1 Opioid Dependence

209299 TAVALISSE FOSTAMATINIB

DISODIUM ORAL TABLET RIGEL 2018-04-17 RX Type 1

Idiopathic Thrombocytopenic Purpura

209521 SEYSARA SARECYCLINE

HYDROCHLORIDE ORAL TABLET ALLERGAN 2018-10-01 RX Type 1 Acne

209627 ANNOVERA SEGESTERONE ACETATE;

ETHINYL ESTRADIOL VAGINAL RING

POPULATION COUNCIL

2018-08-10 RX Type 1 Contraception

209816 NUZYRA OMADACYCLINE TOSYLATE ORAL TABLET PARATEK 2018-10-02 RX Type 1 Infections, SSTI

209817 NUZYRA OMADACYCLINE TOSYLATE INTRAVENOUS POWDER PARATEK 2018-10-02 RX Type 1 Infections, SSTI

210166 MOTEGRITY PRUCALOPRIDE ORAL TABLET SHIRE 2018-12-14 RX Type 1 Constipation,

210238 DOPTELET AVATROMBOPAG MALEATE ORAL TABLET AKARX 2018-05-21 RX Type 1 Thrombocytopenia

210303 ZEMDRI PLAZOMICIN SULFATE INTRAVENOUS SOLUTION ACHAOGEN 2018-06-25 RX Type 1 Infections, Urinary Tract

210365 EPIDIOLEX CANNABIDIOL ORAL SOLUTION GW RESEARCH 2018-09-28 RX Type 1 Myoclonic Seizure

210450 ORILISSA ELAGOLIX SODIUM ORAL TABLET ABBVIE 2018-07-23 RX Type 1 Pain Management,

210493 AKYNZEO

FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

INTRAVENOUS POWDER HELSINN 2018-04-19 RX Type 1 Nausea-Emesis


FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 1 (New Molecular Entity) (2/2)

Application Number


Status Application

Category Indication

210598 YUPELRI REVEFENACIN INHALATION SOLUTION MYLAN 2018-11-09 RX Type 1 COPD

210656 DAURISMO GLASDEGIB ORAL TABLET PFIZER 2018-11-21 RX Type 1 Cancer, AML

210795 KRINTAFEL TAFENOQUINE SUCCINATE ORAL TABLET GSK 2018-07-20 RX Type 1 Infections, Malaria

210806 PIFELTRO DORAVIRINE ORAL TABLET MSD MERCK 2018-08-30 RX Type 1 Infections, HIV/AIDS

210854 XOFLUZA BALOXAVIR MARBOXIL ORAL TABLET GENENTECH 2018-10-24 RX Type 1 Infections, Influenza

210861 VITRAKVI LAROTRECTINIB ORAL CAPSULE LOXO ONCOLOGY

2018-11-26 RX Type 1 Cancer, Solid

210867 MOXIDECTIN MOXIDECTIN ORAL TABLET MDGH 2018-06-13 RX Type 1 Infections, Onchocerciasis

210868 LORBRENA LORLATINIB ORAL TABLET PFIZER 2018-11-02 RX Type 1 Cancer, NSCLC

210910 AEMCOLO RIFAMYCIN ORAL TABLET, DELAYED

RELEASE COSMO TECHNOLOGIES

2018-11-16 RX Type 1 Infections, ETEC

210922 ONPATTRO PATISIRAN SODIUM INTRAVENOUS SOLUTION ALNYLAM 2018-08-10 RX Type 1 Amyloidosis

210923 MULPLETA LUSUTROMBOPAG ORAL TABLET SHIONOGI 2018-07-31 RX Type 1 Thrombocytopenia

210951 ERLEADA APALUTAMIDE ORAL TABLET JANSSEN BIOTECH

2018-02-14 RX Type 1 Cancer, CRPC

211109 XERAVA ERAVACYCLINE

DIHYDROCHLORIDE INTRAVENOUS POWDER TETRAPHASE 2018-08-27 RX Type 1

Infections, Complicated Intra-Abdominal

211155 COPIKTRA DUVELISIB ORAL CAPSULE VERASTEM 2018-09-24 RX Type 1 Cancer, CLL

211172 TEGSEDI INOTERSEN SODIUM SUBCUTANEOUS SOLUTION AKCEA 2018-10-05 RX Type 1 Familial Amyloid Polyneuropathy

211192 TIBSOVO IVOSIDENIB ORAL TABLET AGIOS 2018-07-20 RX Type 1 Cancer, AML

211349 XOSPATA GILTERITINIB ORAL TABLET ASTELLAS 2018-11-28 RX Type 1 Cancer, AML

211651 TALZENNA TALAZOPARIB TOSYLATE ORAL CAPSULE PFIZER 2018-10-16 RX Type 1 Cancer, Breast Metastatic

211710 VITRAKVI LAROTRECTINIB ORAL SOLUTION LOXO ONCOLOGY

2018-11-26 RX Type 1 Cancer, Solid

210491 SYMDEKO

(COPACKAGED) IVACAFTOR; IVACAFTOR,

TEZACAFTOR ORAL TABLET, TABLET VERTEX 2018-02-12 RX Type 1 Cystic Fibrosis


FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 1 (New Molecular Entity / New Combination)

Application Number


Status Application

Category Indication

210251 BIKTARVY BICTEGRAVIR SODIUM;

EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

ORAL TABLET GILEAD SCIENCES

2018-02-07 RX Type 1, 4 Infections, HIV/AIDS,

210496 BRAFTOVI ENCORAFENIB ORAL CAPSULE ARRAY BIOPHARMA

2018-06-27 RX Type 1, 4 Cancer, Melanoma Metastatic

210498 MEKTOVI BINIMETINIB ORAL TABLET ARRAY BIOPHARMA

2018-06-27 RX Type 1, 4 Cancer, Melanoma Metastatic

211288 VIZIMPRO DACOMITINIB ORAL TABLET PFIZER 2018-09-27 RX Type 1, 4 Cancer, NSCLC Metastatic

210589 OMEGAVEN FISH OIL TRIGLYCERIDES INTRAVENOUS EMULSION FRESENIUS KABI 2018-07-27 RX Type 1, 4 Cholestasis


FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 1 (New Active Ingredient)

Application Number


Status Application

Category Indication

209381 PLENVU

ASCORBIC ACID; POLYETHYLENE GLYCOL

3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

ORAL FOR SOLUTION SALIX 2018-05-04 RX Type 2 Bowel Cleansing

211226 KHAPZORY LEVOLEUCOVORIN INTRAVENOUS POWDER SPECTRUM 2018-10-19 RX Type 2 Cancer, Chemo Side Effects


FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 3 (New Dosage Form) (1/2)

Application Number


Status Application

Category Indication

207223 DIACOMIT STIRIPENTOL ORAL FOR SUSPENSION BIOCODEX 2018-08-20 RX Type 3 Myoclonic Seizure

206185 XELPROS LATANOPROST OPHTHALMIC EMULSION SUN PHARMA 2018-09-12 RX Type 3 Ocular Hypertension

207356 ARIKAYCE KIT AMIKACIN SULFATE INHALATION SUSPENSION, LIPOSOMAL

INSMED 2018-09-28 RX Type 3 Infections, Respiratory Tract

208255 SYMFI LO EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL

FUMARATE ORAL TABLET MYLAN 2018-02-05 RX Type 3 Infections, HIV/AIDS

208313 INFUGEM GEMCITABINE

HYDROCHLORIDE INTRAVENOUS SOLUTION SUN PHARM 2018-07-16 RX Type 3 Cancer, Pancreatic Metastatic

208742 DEXTENZA DEXAMETHASONE OPHTHALMIC INSERT OCULAR THERAPEUTIX

2018-11-30 RX Type 3 Ophthalmic Pain

209080 TIGLUTIK KIT RILUZOLE ORAL SUSPENSION ITALFARMACO 2018-09-05 RX Type 3 ALS

209128 DSUVIA SUFENTANIL CITRATE SUBLINGUAL TABLET ACELRX 2018-11-02 RX Type 3 Acute Pain

209184 INBRIJA LEVODOPA INHALATION POWDER ACORDA 2018-12-21 RX Type 3 Parkinson's

209311 JORNAY PM METHYLPHENIDATE

HYDROCHLORIDE ORAL

CAPSULE, EXTENDED

RELEASE IRONSHORE 2018-08-08 RX Type 3 ADHD

209353 ALTRENO TRETINOIN TOPICAL LOTION DOW 2018-08-23 RX Type 3 Acne

209355 JEMDEL HALOBETASOL PROPIONATE UNKNOWN DOW 2018-11-06 RX Type 3 Psoriasis,

209410 OSMOLEX ER AMANTADINE

HYDROCHLORIDE ORAL

TABLET, EXTENDED RELEASE

OSMOTICA 2018-02-16 RX Type 3 Parkinson's

209863 XYOSTED

AUTOINJECTOR TESTOSTERONE ENANTHATE SUBCUTANEOUS SOLUTION ANTARES 2018-09-28 RX Type 3 Hypoandrogenism

210115 PROGRAF TACROLIMUS ORAL FOR SUSPENSION ASTELLAS 2018-05-24 RX Type 3 Transplant Rejection

210361 QBREXZA GLYCOPYRRONIUM TOSYL-

ATE TOPICAL CLOTH DERMIRA 2018-06-28 RX Type 3 Hyperhidrosis

210428 KAPSPARGO

SPRINKLE METOPROLOL SUCCINATE ORAL

CAPSULE, EXTENDED RELEASE

SPIL 2018-01-26 RX Type 3 Hypertension,


FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 3 (New Dosage Form) (2/2)

Application Number


Status Application

Category Indication

210563 IMBRUVICA IBRUTINIB ORAL TABLET PHARMACY-CLICS

2018-02-16 RX Type 3 Cancer, MCL

210655 PERSERIS KIT RISPERIDONE SUBCUTANEOUS FOR SUSPENSION,

EXTENDED RELEASE

INDIVIOR 2018-07-27 RX Type 3 Schizophrenia

210793 NUPLAZID PIMAVANSERIN TARTRATE ORAL CAPSULE ACADIA 2018-06-28 RX Type 3 Psychotic Disorders

210833 SYMPAZAN CLOBAZAM ORAL FILM AQUESTIVE THERAPEUTICS

2018-11-01 RX Type 3 Lennox-Gastaut Syndrome

211210 QMIIZ ODT MELOXICAM ORAL TABLET, ORALLY DISINTEGRATING

TERSERA 2018-10-19 RX Type 3 Osteoarthritis

211358 ORKAMBI IVACAFTOR; LUMACAFTOR ORAL GRANULE VERTEX 2018-08-07 RX Type 3 Cystic Fibrosis

208276 REMODULIN TREPROSTINIL INTRAVENOUS,

SUBCUTANEOUS SOLUTION

UNITED THERAPEUTICS

2018-07-30 RX Type 3 Pulmonary Arterial Hypertension

208612 BALCOLTRA ETHINYL ESTRADIOL; LEVONORGESTREL

ORAL TABLET AVION 2018-01-09 RX Type 3 Female Contraception

204441 JYNARQUE TOLVAPTAN ORAL TABLET OTSUKA 2018-04-23 RX Type 3 Polycystic Kidney Disease


FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 3,4 (New Dosage Form, New Combination)

Application Number


Status Application

Category Indication

206976 LICART DICLOFENAC EPOLAMINE TOPICAL SHAMPOO INSTITUT BIOCHIMIQUE

2018-12-19 RX Type 3,4 Acute Pain

208085 XTRELUS GUAIFENESIN; HYDROCO-DONE BITARTRATE

ORAL TABLET ECI 2018-04-25 RX Type 3,4 Cough And Cold

210566 HALOBETASOL PROPIONATE

HALOBETASOL PROPIONATE TOPICAL AEROSOL, FOAM MAYNE 2018-05-24 RX Type 3,4 Psoriasis

FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 4 (New Combination)

Application Number


Status Application

Category Indication

22141 CIMDUO LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

ORAL TABLET MYLAN 2018-02-28 RX Type 4 Infections, HIV/AIDS

22142 SYMFI EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

ORAL TABLET MYLAN 2018-03-22 RX Type 4 Infections, HIV/AIDS

22343

EFAVIRENZ, LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

ORAL TABLET AUROBINDO 2018-08-15 RX Type 4 Infections, HIV/AIDS

205626 LAMIVUDINE, NEVIRAPINE, ZIDOVUDINE

LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE

ORAL TABLET MICRO LABS 2018-08-13 RX Type 4 Infections, HIV/AIDS

208653 APADAZ ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE

ORAL TABLET KEMPHARM 2018-02-23 RX Type 4 Acute Pain

210045 CONSENSI AMLODIPINE BESYLATE; CELECOXIB

ORAL TABLET KITOV 2018-05-31 RX Type 4 Pain Management

210132 BIJUVA ESTRADIOL; PROGESTERONE ORAL CAPSULE THERAPEUTICS- MD

2018-10-28 RX Type 4 Menopause

210455 SYMTUZA

COBICISTAT; DARUNAVIR ETHANOLATE; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

ORAL TABLET JANSSEN 2018-07-17 RX Type 4 Infections, HIV/AIDS

210807 DELSTRIGO DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

ORAL TABLET MSD MERCK 2018-08-30 RX Type 4 Infections, HIV/AIDS


FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 5 (New Formulation or Manufacturer) (1/3)

Application Number


Status Application

Category Indication

209566 SEIZALAM MIDAZOLAM

HYDROCHLORIDE INTRAMUSCULAR SOLUTION MERIDIAN 2018-09-14 RX Type 5 Status Epilepticus

22517 NOCDURNA DESMOPRESSIN ACETATE SUBLINGUAL TABLET FERRING 2018-06-21 RX Type 5 Nocturia

202158 RADIOGENIX

SYSTEM

TECHNETIUM TC-99M SODIUM PERTECHNETATE

GENERATOR

INTRAVENOUS, INTRAVESICULAR,

OPHTHALMIC SOLUTION

NORTHSTAR MEDICAL

2018-02-08 RX Type 5 Diagnostic Agents

204417 ELEPSIA XR LEVETIRACETAM ORAL TABLET, EXTENDED

RELEASE SUN PHARMA 2018-12-20 RX Type 5 Epilepsy

205054 LUTRATE DEPOT

KIT LEUPROLIDE ACETATE INTRAMUSCULAR FOR SUSPENSION GP-PHARM 2018-08-28 RX Type 5 Cancer, Prostate

205580 BELRAPZO BENDAMUSTINE HYDRO-

CHLORIDE IV (INFUSION) SOLUTION EAGLE 2018-05-15 RX Type 5 Cancer, NHL

207962 ZTLIDO LIDOCAINE TOPICAL PATCH SCILEX 2018-02-28 RX Type 5 Neuropathic Pain

207987 ABLYSINOL ALCOHOL INTRA-ARTERIAL SOLUTION BELCHER 2018-06-21 RX Type 5 Cardiomyopathy

208042 CASSIPA BUPRENORPHINE HYDROCHLORIDE;

NALOXONE HYDROCHLORIDE SUBLINGUAL FILM TEVA 2018-09-07 RX Type 5 Opioid Dependence

208288 SOLUPREP CHLORHEXIDINE

GLUCONATE; ISOPROPYL ALCOHOL

TOPICAL SOLUTION 3M HEALTH CARE

2018-08-08 RX Type 5 Infections, Bacterial

208564 IMVEXXY ESTRADIOL VAGINAL INSERT THERAPEU-TICSMD

2018-05-29 RX Type 5 Vaginal Atrophy

208614 DOXERCALCI-

FEROL DOXERCALCIFEROL INJECTION INJECTABLE HOSPIRA 2018-07-24 RX Type 5 Secondary Hyperparathyroidism

208647 EZALLOR ROSUVASTATIN ORAL CAPSULE SUN PHARMAL 2018-12-18 RX Type 5 Hypertriglyceridemia

208901 TOLSURA ITRACONAZOLE ORAL CAPSULE MAYNE 2018-12-11 RX Type 5 Skin Infections, Fungal

208910 FIRVANQ KIT VANCOMYCIN

HYDROCHLORIDE ORAL FOR SOLUTION RXMTM 2018-01-26 RX Type 5 Diarrhea

208912 DEXYCU KIT DEXAMETHASONE INTRAOCULAR SUSPENSION EYEPOINT 2018-02-09 RX Type 5 Eye Inflammation,

209191 BORTEZOMIB BORTEZOMIB INTRAVENOUS,

SUBCUTANEOUS POWDER HOSPIRA 2018-07-12 RX Type 5 Cancer, Multiple Myeloma



Application Number


Status Application

Category Indication

209260 ATROPINE SULFATE

ATROPINE SULFATE

IV (INFUSION), INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL

SOLUTION FRESENIUS KABI 2018-01-26 RX Type 5 Intoxication/Poisoning

209481 VANCOMYCIN HYDROCHLO-

RIDE

VANCOMYCIN HYDROCHLORIDE

INTRAVENOUS POWDER MYLAN 2018-07-10 RX Type 5 Sepsis

209607 AZEDRA IOBENGUANE I 131 INJECTION INJECTABLE PROGENICS 2018-07-30 RX Type 5 Pheochromocytoma

209830 ARISTADA INI-

TIO KIT ARIPIPRAZOLE LAUROXIL INTRAMUSCULAR

SUSPENSION, EXTENDED

RELEASE ALKERMES 2018-06-29 RX Type 5 Schizophrenia

209844 LYMEPAK DOXYCYCLINE HYCLATE ORAL TABLET CHARTWELL 2018-06-15 RX Type 5 Infections, Lyme Disease

210308 YONSA ABIRATERONE ACETATE ORAL TABLET SUN PHARMA 2018-05-22 RX Type 5 Cancer, CRPC Metastatic

210331 YUTIQ FLUOCINOLONE ACETONIDE INTRAVITREAL IMPLANT EYEPOINT 2018-10-12 RX Type 5 Uveitis

210565 INVELTYS LOTEPREDNOL ETABONATE OPHTHALMIC SUSPENSION/

DROPS KALA 2018-08-22 RX Type 5 Eye Inflammation

210607 ARAKODA TAFENOQUINE SUCCINATE ORAL TABLET 60 DEGREES 2018-08-08 RX Type 5 Infections, Malaria

210913 CEQUA CYCLOSPORINE OPHTHALMIC SOLUTION SUN PHARMA 2018-08-14 RX Type 5 Dry Eye Syndrome

210997 GLYRX-PF GLYCOPYRROLATE INTRAMUSCULAR,

INTRAVENOUS SOLUTION EXELA PHARMA 2018-07-11 RX Type 5 Anesthesia

211158 TIGECYCLINE TIGECYCLINE INTRAVENOUS POWDER AMNEAL 2018-08-02 RX Type 5 Infections, SSTI

211284 TEMIXYS LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

ORAL TABLET CELLTRION 2018-11-16 RX Type 5 Infections, HIV/AIDS

211580 SPY AGENT GREEN KIT

INDOCYANINE GREEN INTRAVENOUS, INTERSTITIAL

POWDER NOVADAQ 2018-11-21 RX Type 5 Diagnostic Agents

212319 ATROPINE

AUTOINJECTOR ATROPINE INTRAMUSCULAR SOLUTION RAFA LABS 2018-07-09 RX Type 5 Intoxication/Poisoning

22344

LAMIVUDINE TENOFOVIR DISOPROXIL FUMARATE

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

ORAL TABLET AUROBINDO 2018-05-15 RX Type 5 Infections, HIV/AIDS



Application Product Name Molecule/API Name Route Dosage Form Company Name Approval Date Marketing Application Indication

208744 TIGECYCLINE TIGECYCLINE INTRAVENOUS POWDER ACCORD 2018-01-18 RX Type 5 Infections, SSTI

209552 ARGATROBAN

IN SODIUM CHLORIDE

ARGATROBAN INTRAVENOUS SOLUTION AUROBINDO 2018-11-27 RX Type 5 Anticoagulant, antithrombotic

210906

CALCIUM GLUCONATE IN

SODIUM CHLORIDE

CALCIUM GLUCONATE INTRAVENOUS SOLUTION HQ SPECIALITY 2018-10-29 RX Type 5 Hypocalcemia

207964 READYPREP

CHG CHLORHEXIDINE

GLUCONATE TOPICAL CLOTH MEDLINE 2018-11-20 RX Type 5 Infections, Surgical Preparation

205920 PRIMATENE

MIST EPINEPHRINE INHALATION AEROSOL ARMSTRONG 2018-11-07 OTC Type 5,8 Asthma

FDA Drugs Division - 2018 NDA (New Drug) Approvals, Type 9 (New Indication …)

Application Number


Status Application

Category Indication

208855 VERZENIO ABEMACICLIB ORAL TABLET ELI LILLY 2018-02-26 RX Type 9 Cancer, Breast Metastatic


FDA Drugs Division - 2018 NDA (New Drug) Tentative Approvals

Application Number


Status Application

Category Indication

210296 MONOMETHYL

FUMARATE MONOMETHYL FUMARATE ORAL CAPSULE BANNER 2018-11-16 TENTAPP Type 2 MS, Relapsing Remitting

210661 PEMETREXED PEMETREXED INJECTION INJECTABLE APOTEX 2018-03-28 TENTAPP Type 2 Cancer, NSCLC Metastatic

210136 BRIXADI BUPRENORPHINE SUBCUTANEOUS INJECTION, EXTENDED RELEASE

BRAEBURN 2018-12-21 TENTAPP Type 3, 4 Opioid Dependence

205493



ORAL TABLET MICRO LABS 2018-01-25 TENTAPP Type 4 Infections, HIV/AIDS, Other

210237 DOLUTEGRAVIR EMTRICITABINE;

TENOFOVIR

DOLUTEGRAVIR; EMTRICITABINE;

TENOFOVIR ALAFENAMIDE ORAL TABLET MYLAN 2018-02-09 TENTAPP Type 4 Infections, HIV/AIDS, Other

209764 LUSDUNA INSULIN GLARGINE INJECTION INJECTABLE MERCK SHARP DOHME

2018-02-22 TENTAPP Type 5 Diabetes, Type 2

210540 LOPINAVIR; RITONAVIR

LOPINAVIR; RITONAVIR ORAL UNKNOWN MYLAN 2018-08-16 TENTAPP Type 5 Infections, HIV/AIDS, Other

205389 EFAVIRENZ EFAVIRENZ ORAL TABLET MICRO LABS 2018-02-23 TENTAPP Type 5 Infections, HIV/AIDS, Other

207970 CABAZITAXEL

INJECTION CABAZITAXEL INJECTION INJECTABLE ACTAVIS 2018-01-17 TENTAPP Type 5 Cancer, CRPC Metastatic

210326 FULVESTRANT FULVESTRANT INJECTION INJECTABLE FRESENIUS KABI 2018-06-29 TENTAPP Type 5 Cancer, Breast, Other

210850 SINCALIDE SINCALIDE INJECTION INJECTABLE MAIA 2018-02-23 TENTAPP Type 5 Diagnostic Agents, Other

210601 BENDA-

MUSTINE HY-DROCHLORIDE

BENDAMUSTINE HYDROCHLORIDE

IV (INFUSION) SOLUTION APOTEX 2018-11-13 TENTAPP Type 5 Cancer, CLL


FDA Drugs Division - 2018 NDA (New Drug) Approvals - Notable Supplements

Application Number


Status Application

Category Indication

21945 MAKENA 17 ALPHA-

HYDROXYPROGESTERONE CAPROATE

INJECTION AUTOINJECTORS,

DISPOSABLE AMAG 2018-02-14 RX Supplement Preterm Birth

206538 TOUJEO MAX

SOLOSTAR INSULIN GLARGINE

RECOMBINANT INJECTION

INJECTION PENS, DISPOSABLE

SANOFI 2018-03-26 RX Supplement Diabetes

125472 ACTEMRA TOCILIZUMAB INJECTION AUTOINJECTORS,

DISPOSABLE CHUGAI 2018-11-19 RX Supplement Rheumatoid Arthritis

207534 SYMJEPI EPINEPHRINE INJECTION SPECIALTY SYRINGES

ADAMIS 2018-09-27 RX Supplement Anaphylaxis

103976 XOLAIR OMALIZUMAB INJECTION PREFILLED SYRINGE

GENENTECH 2018-09-28 RX Supplement

Allergic Rhinitis Urticaria Asthma Sinusitis

19959 NOVOLIN N

(FlexPen) INSULIN ISOPHANE INJECTION


NOVO NORDISK 2018-06-01 OTC Supplement Diabetes

19991 NOVOLIN 70/30

(FlexPen) INSULIN,

HUMAN RECOMBINANT INJECTION


NOVO NORDISK 2018-06-01 OTC Supplement Diabetes

19938 NOVOLIN R (FlexPen)

INSULIN, HUMAN RECOMBINANT

INJECTION INJECTION PENS,

DISPOSABLE NOVO NORDISK 2018-06-01 OTC Supplement Diabetes


2018 FDA Approvals Summary - pharmacircle.com...TESTOSTERONE ENANTHATE SUUTANEOUS SOLUTION ANTARES...

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