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LIST OF APPROVED DRUG FROM 01-01-2014 to 11.07.

2014
1 Regorafenib flm coated tablet
40 mg
For the treatment of patients
with metastatic colorectal
cancer (CRC) who have been
previously treated with
uoropyrimidine! o"aliplatin
and irinotecan#base
chemotherapy! ananti#$%&F
therapy! and! if 'R() wild
type! an anti#%&FR therapy*+
,,+0-+.0,
4
2 (/acitidine for in0ection ,00
mg1vial
For the treatment of adult
patients with all subtypes of
2yelodysplastic )yndrome
,3+03+,4
3 4ulobuterol 4ransdermal 5atch
0+3 mg1 ,+0 mg 1 .+0 mg+
For treatment of patients with
(sthma and C657 without
co#morbidity
,3+03+,4
4 5egaspargase 8n0ection 9!-30 8:13
m;
8ndicated as a component of
multi agent
chemotherapeutic regimen
for the treatment of
patients with acute
lymphoblastic leu<emia who
are hypersensitive to
asparaginase
0,+03+,4
5 4olterodine 4artrate %"tended
release tablets .mg14mg
((dditional 7osage Form)
For the treatment of
overactive bladder with
symptoms of urge urinary
incontinence! urinary
incontinence! urgency and
fre=uency
9,+0,+,4
6 >orte/omib for in0ection 9+3mg
()ub#cutaneous route of
administration as an alternate
to intravenous route)
((dditional route of
administration)
)ame as already approved .?+0,+,4
7 5aclita"el 8n0ection Concentrate
for @anodispersion ,00mg and
900mg
((dditional 7osage Form)
For the treatment of >reast
cancer after failure of
combination therapy
metastatic disease or relapse
within si" months of ad0uvant
chemotherapy+ 5rior therapy
should have included an
anthracycline unless clinically
contraindicated
..+0,+.0,
4
8 Aeparin )odium 4opical
)olution ,000 8:1ml ((dditional
7osage Form)
For the management of post
infusion superfcial
thrombophlebitis+
,B+0,+.0,
4
C
)imethicone 6rally
disintegrating strip B.+3mg
((dditional 7osage Form)
Flatulance and as ad0uvant in
hyperacidity+
,4+,,+.0,
0
,0+ 2ontelu<ast sodium chewable (s add on therapy in mild to .B+0.+.00
tablet 4mg13mg and
2ontelu<ast sodium flm
coated tablet ,0mg+
moderate asthma
inade=uately controlled by
inhaled corticosteroids and
short active >. agonist!
%"ercise induced
bronchoconstriction+ .
,,
%ltrombopag 6lamine tablet
.3130mg ((dditional 8ndication)
8ndicated in patients with
chronic hepatitis C $irus
(AC$) infection for the
treatment of
thrombocytopenia toD %nable
the initiation of interferon
based therapy! optimise
interferon based therapy+
0-+04+.0,
4
,.
7ecitabine lyophilised powder
for in0ection 30mg1.0ml vial
((dditional indication)
For the treatment of adult
patients aged B3 years and
above with newly diagnosed
de novo or secondary acute
myeloid leu<emia ((2;)!
according to Eorld Aealth
6rganisation (EA6)
classifcation! who are not
candidates for standard
induction chemotherapy+
0C+04+.0,
4
,9
&lycopyrronium bromide
inhalation powder hard capsule
with inhaler+ %ach capsule
contains B9mcg
&lycopyrronium bromide e=+ to
&lycopyrronium 30 mcg+
8ndicated as a once# daily
maintenance bronchodilator
treatment to relieve
symptoms of patients with
Chronic 6bstructive
5ulmonary 7isease (C657)+
0,+04+.0,
4
,4
2icafungin sodium for in0ection
,00mg1vial ((dditional
)trength)
4reatement of patient with
candidemia! acute
7isseminated Candidiasis!
Candida 5eritonitis and
abscesses+ 4reatment of
patients with %sophageal
Candidiasis! 5rohyla"is of
Candidia and (spergillus
8nfections in patients
undergoing Aemopoeitic
stem cell transplantaion+
4reatment of patient with
Fungemia! Respiratory
mycosis! &astrointestinal
mycosis caused by
(spergillus sp++ .+03+.0,4
,3 (pi"aban tablets .+3mg13mg
((dditional )trength and
(dditional 8ndication)
5revention of stro<e and
systemic embolism in adult
patients with non#valvular
artrial fbrillation (@$(F)!
including those with one or
more ris< factors! such as
prior stro<e or transient
,B+03+.0,
4
ischemic attac< (48()F
ageG-3 yearsF hypertensionF
diabetes mellitusF
symptomatic heart failure
(@HA( classG88)+ Compared to
warfarin api"aban also
results in less bleeding!
including intracranial
hemorrhage+
,B
2ometasone furoate nasal
spray 30 mcg1dose
((dditional 8ndication)
For the treatment of nasal
symptoms of seasonal
allergic and perennial allergic
rhinitis! in adults and
pediatric patients . years of
age and older+
.,+03+.0,
4
,- &emcitabine ACl in0ection
ready to use infusion bags
&emcitabine AC; e=uivalent to
&emcitabine ,0mg per m;
(,00!,.0!,90!,40!,30!,B0!,-0!
,?0!,C0 and .00m;)
((pproved as infusion bags)
6varian cancer#&emcitabine
in0ection in combination with
cisplatin is indicated for the
treatment of patients with
advanced ovarian cancer that
has replaced at least B
months after completion of
platinum based therapy+
>reast Cancer#&emcitabine
in0ection in combination with
5aclita"el is indicated for the
frst line treatment of
patients with metastatic
breast cancer after failure of
prior anthracycline containing
ad0uvant chemotherapy!
unless anthracyclinces were
clinically contraindicated+
@on#small cell lung concer#
&emcitabine in0ection is
indicated in combination with
cisplatin for the frst line
treatment of patients with
inoperable! locally advanced
()tage 888( or 888>)! or
metastatic (stage 8$) non#
small cell lung cancer+
5ancreatic cancer#
&emcitabine in0ection is
indicated as frst#line
treatment for patient with
locally advanced
(nonresectable )tage 88 or
)tage 888) or metastatic
()tage 8$) adenocarcinoma of
the pancreas+&emcitabine
in0ection is indicated for
patients previously treated
,-+0B+.0,
4
with 3 #F:+
,?
4adalafl 6rally 7isintegrating
)trip ,0mg I .0mg
((dditional dosage form)
For erectile dysfunction 90+0-+.0,
4
,C
Aydro"ychloro=uine )ulphate
400 mg tablets
((dditional 8ndication)
(s an ad0unct to diet and
e"ercise to improve glycemic
control of patients on
metformine! sulfonylurea
combination in patients with
4ype 88 7iabetes+
.?+0-+.0,
4
.0
@evirapine %"tended release
tablet 400mg
((dditional )trength)
For use in combination with
other anti#retroviral agents
for the treatment of A8$#,
infection in adults
0,+0-+.0,
4
.,
Cerebrolysin solution for
in0ection+ %ach ml containsD
5orcine brain derived peptide
preparation (Cerebrolysine
concentrate) .,3+.mg
For amelioration of cranial
in0ury! cerebrovascular
pathological se=uelae and
aprose"ia in dementia+
.3+0-+.0,
4
..
(rtesunate powder for in0ection
with phosphate buJer+
(rtesunate B0mg1vial
alongwith Bml ampoule of
phosphate buJer solution (pA
?+0F0+902)
For the treatment of severe
Falciparum malaria in areas
where there is evidence if
=uinine resistance
0.+0-+.0,
4