Updated List 2014

8/17/2019 Updated List 2014

1/18

Drugs approved from 1st Jan 2014 till present

S.No Drug Indication

1

2

Same as already approved

3

4

5

6

Tolterodine Tartrate Extended release talets2mg!4mg "#dditional Dosage $orm%

$or t&e treatment ofovera'tive ladder (it&symptoms of urge urinaryin'ontinen'e) urinary

in'ontinen'e) urgen'y andfre*uen'y+

,orte-omi for in.e'tion 3+5mg "Su/'utaneous route of administration as analternate to intravenous route% "#dditionalroute of administration%

a'litaxel n.e'tion on'entrate foranodispersion 100mg and 300mg"#dditional Dosage $orm%

$or t&e treatment of ,reast'an'er after failure of'omination t&erapy

metastati' disease orrelapse (it&in six mont&s ofad.uvant '&emot&erapy+rior t&erapy s&ould &avein'luded an ant&ra'y'lineunless 'lini'ally'ontraindi'ated+

eparin Sodium Topi'al Solution 1000 !ml"#dditional Dosage $orm%

$or t&e management of postinfusion super'ialt&romop&leitis+

Simet&i'one 7rally disintegrating strip62+5mg

$or t&e treatment of8atulan'e and as ad.uvant in&ypera'idity+

Eltromopag 7lamine talet 25!50mg"#dditional ndi'ation%

ndi'ated in patients (it&'&roni' &epatitis 9irus"9% infe'tion for t&etreatment oft&romo'ytopenia to: Enalet&e initiation of interferon

ased t&erapy) optimiseinterferon ased t&erapy+


2/18

;

<

=

De'itaine lyop&ilised po(der for in.e'tion

50mg!20ml vial "additional indi'ation%

$or t&e treatment of adultpatients aged 65 years andaove (it& ne(ly diagnosedde novo or se'ondary a'utemyeloid leu>emia "#?@%)

a''ording to Aorld ealt&7rganisation "A7%'lassi'ation) (&o are not'andidates for standardindu'tion '&emot&erapy+

Bly'opyrronium romide in&alation po(der&ard 'apsule (it& in&aler+ Ea'& 'apsule

'ontains 63m'g Bly'opyrronium romide e*+to Bly'opyrronium 50 m'g+

ndi'ated as a on'e dailymaintenan'e ron'&odilatortreatment to relieve

symptoms of patients (it&&roni' 7stru'tiveulmonary Disease "7D%+

?i'afungin sodium for in.e'tion 100mg!vial"#dditional Strengt&%

Treatement of patient (it&'andidemia)a'uteDisseminated andidiasis)andida eritonitis andas'esses+Treatment of

patients (it& Esop&agealandidiasis)ro&ylaxis ofandidia and #spergillusnfe'tions in patientsundergoing emopoeiti'stem 'elltransplantaion+Treatment ofpatient (it& $ungemia)Cespiratory my'osis)Bastrointestinal my'osis'aused y #spergillus sp++


3/18

10

11

12

#'ute &emorr&oid piles

#pixaan talets 2+5mg!5mg "#dditionalStrengt& #dditional ndi'ation%

revention of stro>e andsystemi' emolism in adultpatients (it& non/valvularartrial rillation "9#$%)in'luding t&ose (it& one or

more ris> fa'tors) su'& asprior stro>e or transientis'&emi' atta'> "T#%ageF;5 years &ypertensiondiaetes mellitussymptomati' &eart failure"G# 'lassF%+ omparedto (arfarin apixaan alsoresults in less leeding)in'luding intra'ranial&emorr&age+

?ometasone furoate nasal spray 50m'g!a'tuation "#dditional ndi'ation%

$or t&e treatment of nasalsymptoms of seasonalallergi' and perennialallergi' r&initis) in adults andpediatri' patients 2 years ofage and older+

?i'ronised uried $lavonoid 1000mg

"?$$%+ HEa'& lm 'oated talet 'ontainsdiosmin =00mg and 8avonoids expressed asesperidine 100 mg of ?i'ronised uried$lavonoid fra'tion of Cuta'eae 1000mg"?$$%H


4/18

13

14$or ere'tile dysfun'tion

15

16

Bem'itaine l in.e'tion ready to useinfusion agsBem'itaine @ e*uivalent to Bem'itaine10mg per m@"100)120)130)140)150)160)1;0)1


5/18

1;

1<

1=

20

21

22

#rtesunate in.e'tion+ Ea'& 'omipa'>'ontains: H#rtesunate for in.e'tion 120mg" Ea'& vial 'ontains #rtesunate 120mg%)Sodium i'aronate in.e'tion 5I(!v "Ea'&2ml ampoule 'ontains: Sodium ,i'aronate

5I (!v%) Sodium '&loride n.e'tion 0+=I(!v "Ea'& 10ml ampoule 'ontains: Sodium'&loride 0+=I (!v%H

romoted for use in severemalaria in'luding 'ereralmalaria as a se'ond line in'&loro*uine resistant malaria

'ases only+

ererolysin solution for in.e'tion+ Ea'& ml'ontains: or'ine rain derived peptidepreparation "ererolysine 'on'entrate%215+2mg

$or amelioration of 'ranialin.ury) 'ererovas'ularpat&ologi'al se*uelae andaprosexia in dementia+

#rtesunate po(der for in.e'tion 60mg!vialalong(it& 6ml ampoule of p&osp&ate uersolution "p ast sodium lm'oated talet 10mg+

#s add on t&erapy in mild tomoderate ast&mainade*uately 'ontrolled yin&aled 'orti'osteroids ands&ort a'tive ,2 agonist)

Exer'ise indu'edron'&o'onstri'tion+

@a'toa'illus revis D2 @o-enges 100mg"'orresponding to not less t&an 1 illion% of

live) lyop&ilised) la'ti' a'id a'teria)@a'toa'illus revis D2+

"#dditional indi'ation%

revention of radiot&erapyand '&emot&erapy indu'ed

oral mu'ositis in 'an'erpatients+

Civaroxaan talet 15!20mg"#dditional strengt&!indi'ation%

1+ Treatment of deep veint&romosis and for

prevention of re'urrent D9Tand pulmonary emolism+ 2+$or t&e prevention of stro>eand systemi' emolism inpatient (it& non/valvular

arterial rillation+


6/18

23

24

25

26

2;

2<

ydroxy'&loro*uine Sulp&ate Talet 300mg"#dditional strengt&!indi'ation%

ndi'ated for t&e treatmentof patietns (it& lo(er ody

(eig&t i+e 45 to 60>g inC&emuatoid art&ritis)

Systemi' @upus

Eryt&ematosus olymorp&i' @ig&t Eruption

Bin>go iloa extra't Talet 120mg"#dditional strengt&%

$or t&e treatment ofdementia) vertigo and

tinnitus in adult patients+

,endamustine ydro'&loride lyop&ilisedin.e'tion 25mg

"#dditional strengt&%

Treatment of patients (it&'&roni' lymp&o'yti'

leu>emia

?etformin EC talet ;50mg"#dditional strengt&%

#s an ad.un't to diet andexer'ise to improve gly'emi'

'ontrol in adult patients(it& Type Diaetes+

Sorafeni tosylate talet 200mg"#dditional indi'ation%

$or t&e treatment of patients

(it& lo'ally advan'ed ormetastati' dierentiated

t&yroid 'ar'inoma refra'toryto radioa'tive iodine+

Deferasirox Dispersile talet 100!400mg"#dditional indi'ation%

Treatment of '&roni' ironoverload in patients (it&

non/transfusion dependentt&alassemia "TDT%

syndromes aged 10 years

and older+


7/18

2=

30

31

32

?#T, mesilate100!400mg talets and 100

mg 'apsules "#dditionalindi'ation%

Treatment of aediatri'patients (it& ne(ly

diagnosed &iladelp&ia'&romosome positive a'ute@ymp&olasti'@eu>aemia"&K#@@% integrated (it&

'&emot&erapy

Tapentadol Extended release talet100!150!200mg "#dditional strengt&%

$or use in in/patients under&ospital setting for severea'ute pain for a period not

ex'eeding 5 days

7lan-apine pamoate rolonged releasepo(der for suspension for +? in.e'tion"'omi pa'>%Ea'& 'omipa'> 'ontainsa+ 9ial of 7lan-apine pamoate rolongedrelease po(der for suspension+

Ea'& vial 'ontains: 7lan-apine pamoatemono&ydrate e* to 7lan-apine+++++210mg!300mg!405mg+#fter re'onstituton ea'& m@ of suspension'ontains 150mg+

+ 9ial of ve&i'le: 3m@ 'lear) 'olourless toslig&t yello( solution 'ontains:?anitol ++++ 5+0;0I(!vSodium 'aroxymet&yl 'ellulose ++++ 0+;;0I(!v olysorate


8/18

33

34

Pegasperagase 3,750 IU/5 mL

35

Tulobuterol Transdermal Patch 0.5 mg/ 1.0 mg /2.0 mg

36

!ac"t"d"ne 100 mg / #"al

3;

!ac"t"d"ne

3<

$egora%en"b %"lm coated tablet &0 mg

Daigatran Etexilate ?esilate &ard gelatin'apsule ;5!110!150mg

"#dditional ndi'ation%

1+ Treatment of a'ute deepvein t&romosis "D9T% and

!or pulmonary emolism "E%and prevention of related

deat&+ 2+revention ofre'urrent deep vein

t&romosis "D9T% and !orpulmonary emolism "E%

and related deat&

Ind"cated as a component o% mult"agent chemotherapeut"c reg"men%or the treatment o% pat"ents '"thacute l(mphoblast"c leu)em"a 'hoare h(persens"t"#e to asparag"nase

*or treatment o% pat"ents '"thsthma and +P- '"thout comorb"d"t(

*or the treatment o% adult pat"ents'"th all subt(pes o% (elod(splast"c(ndrome

*or the treatment o% adult pat"ents'"th all subt(pes o% (elod(splast"c(ndrome

*or the treatment o% pat"ents '"thmetastat"c colorectal cancer +$+'ho ha#e been pre#"ousl( treated'"th %luorop(r"m"d"ne, o4al"plat"nand "r"notecanbase chemotherap(,anant"6* therap(, and, "% 8$'"ld t(pe, an ant"6*$ therap(9.


9/18

3=

$o%lum"last Tab 500 mcg

40

41

42

43

*or : $elaps"ng rem"tt"ng mult"ple sc

44

45

46

logl"pt"n Tablet ;.25 mg/12.5 mg/ 25 mg

4;

4<

4=

50

51

#xitini Talet 1mg!5mg52

53

linastatin n.e'tion54

55

anagli8o-in Talet 100!300mg56

*or the treatment o% se#ere chron"cobstruct"#e pulmonar( d"sease+P-*61 postbronchod"latorless than 50< pred"cted assoc"ated'"th chron"c bronch"t"s "n adult pat"ents '"th a h"stor( o% %re=uente4acerbat"ons as add on to

bronchod"lator treatment.

-"meth(l *umarate dela(ed release 120 mg/2&0 mgTablet

: To "mpro#e gl(cem"c control "ncomb"nat"on '"th other glucoselo'er"ng med"c"n"al products

"nclud"ng "nsul"n 'hen thesetogether '"th d"et and e4erc"se, donot pro#"de ade=uated gl(cem"ccontrol or as monotherap( asad>unct to d"et and e4erc"se to"mpro#e gl(cem"c control "n adultsaged 1? (ears or older '"th t(pe 2-"abet"c mell"tus.:

*or the treatment o% ad#ancedrenal cell carc"noma a%ter %a"lure o%one pr"or s(stem"c therap(9

*or the treatment o% m"ld to se#ereacute pancreat"t"s.

Ind"cated as an ad>unct to d"et and

e4erc"se to "mpro#e gl(cem"ccontrol "n adults '"th T(pe2-"abet"c ell"tus9.


10/18

Date

31+01+14

2


11/18

0=+04+2014

01+04+2014

2+05+2014


12/18

16+05+2014

21+05+2014

2


13/18

1;+06+2014

30+0;+2014

2


14/18

13+11+2013

25+0;+2014

02+0;+2014

26+02+2002

=!

2+=+14


15/18

=!

=!12!2014

1=+=+2014

25+=+14

25+=+14

26+=+2014


16/18

=!=!2014

=+12+13

14+10+14

2


17/18

1;+11+14

07 03 201&

2& 0& 1&

2@ 0& 1&

23 07 1&

01 07 1&


18/18

17 07 1&

27 0? 1&

27 0? 1&

1

Updated List 2014

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Transcript of Updated List 2014