List of Approved Drug for Marketing in India
(from 01.01.2009 to 30.12.2009)
S.No.
Drug Name
Indication
Approval Date
1
Zoledronic Acid Injection 5mg/100ml (Addl. Indication)
For the treatement of osteoporosis in
post-menopausal women and in men who are at increased risk of fracture,including those with a
recent low-trauma hip fracture.
07.01.09
2.
Misoprostol Tablet 600mcg
Addl. Strength
09.01.09
3
Acebrophylline Syrup 10mg/ ml
For the treatement of adult patients with
chronic obstructive pulmonary disease(COPD) and
bronchial asthma.
09.01.09
4
Selamectin Tropical solution (for verterinary use.)
60mg/120mg per ml
(I) For the treatement and lasting
prevention of flea infestations,treatment and
control of flea allergy dermatitis, prevention of heartworm disease,treatement and prevention of ear mites in dogs
and cats;
(II) For the treatement and prevention of sarcoptic mange,roundworms and for control of tick infestations in dogs.
09.01.09
5
Methylcobalamin1500mcg + Calcium 200mg + Calcitriol 0.25mcg + Folic Acid1.5mg + Pyridoxine3mg Capsules
For the treatment of vitamin deficiency states in adults
14.01.09
6
Metoprolol tartrate tablets 50 mg (Addl. Indication)
Adjunct to the treatement of Hyperthyroidism
14.01.09
7
Cinacalet (as HCl) Tablet 30/60/90mg
For the treatment of secondary hyper parathyroidism in patients with chronic kidney diseases (CKD) on dialysis and for
hypercalcemia in patients with parathyroid carcinoma
14.01.09
8
Mycophenolate mofetil Capsules 250mg, Tablets 500mg, Oral
suspension 200mg/ml (addl. Indication)
For the prophylaxis of acute organ rejection in patients recieving allogenic hepatic transplantation.
23.01.09
9
Liquid Paraffin1.25ml + Milk of Magnesia 3.75ml + Sodium Picosulphate 3.33mg per 5ml
For symptomatic treatment of constipation in adults
29.01.09
10
Ranolazine 1000mg ER Tabs (Additional Strength)
Same as approved
31.01.09
11
Hyaluronic acid (cross linked) Pre-filled syringe 18mg/0.6ml and 24mg/0.8ml
For intradermal implantation and facial soft tissue augmentation
31.01.09
12
Caspofungin acetate Injection (Addl. Indication)
For use in following: (I) Empirical therapy for presumed fungal
infections in febrile neutropenic patients.
(II) Treatment of Candidemia and the
following Candida infections: Intra-abdominal abscesses, Peritonitis and
Pleural space infections.
(III) Treatment of Esophageal Candidiasis.
(IV) Treatment of invasive Aspergillosis in patients who are
refractory to or intolerant of other therapies (i.e,
amphotericin B, lipid formulations of amphotericin B, and/or itraconazole)
31.01.09
13
Micafungin ( as sodium) Powder for solution for infusion 50mg / vial
For the treatment of patients with candidemia,
acute disseminated candidiasis, candida peritonitis, abscess and esophageal candidiasis.
For the prophylaxis of Candida infection in patients undergoing hematopoietic
stem cell transplantation (HSCT)
31.01.09
14
Loteprednol Etabonate Nasal spray 0.1% w/v
For prophylaxis and treatment of the nasal symptoms of seasonal
allergic rhinitis.
31.01.09
15
Rasagiline (as mesylate ) Tablet 0.5mg/1mg
For the tratment of signs and symptoms of
idiopathic Parkinson's disease as intial monotherapy and as an addition to levodopa.
31.01.09
16
Nicotine Polacrilex Gum 2mg & 4mg (Addl.
Indication)
To reduce the withdrawal symptoms, including nicotine craving,
associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco.
03.02.09
17
Closantel Injection100mg/ ml (for verterinary use.)
For the infestation of trematodes, nematodes, cestodes and arthropods
of domestic animals, including milch and other food
producing animals.
05.02.09
18
Lornoxicam 4mg + Paracetamol 500mg film coated tablets
For the short term use in acute painful & inflammatory conditions
in adults
05.02.09
19
Cetrimide15% w/v + Chlorhexidine Gluconate 7.5% v/v + Isopropyl Alcohol
7.5% v/v Concentrate Solution
For cleansing of physically contaminated wounds and for pre-operative
disinfection
09.02.09
20
Ketoconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) Solution
For the treatment of dandruff
09.02.09
21
Doripenem (as monohydrate) Injection 250mg/500mg
For the treatment of nosocomial pneumonia in adults.
16.02.09
22
Halobetasol Scalp Approved 0.05% w/v
For the relief of inflammatory and puritic manifestation of corticosteroid respensive dermatosis
18.02.09
23
Nicotine (as Polacrilex) Lozenges 2mg &
4mg
To reduce the withdrawal symptoms, including nicotine craving,
associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco.
18.02.09
24
Tranexamic Acid Tab SR 750mg
For the treatment of menorrhagia
20.02.09
25
Betahistine Mesilate Tablet 6mg/12mg
For the treatment of dizziness and feeling of dizziness resulting from
Meniere's disease, Meniere's syndrome and vertigo.
20.02.09
26
Abatacept Injection 250mg/vial (Addl. Indication)
In moderately to severly active rheumatoid arithritis in adults and may be used as monotherapy or concomitantly with DMARD's other than TNF
antagonists
20.02.09
27
Anidulafungin Injection (Lyophilized powder) 50mg/100mg per vial
For the treatment of invasive candidiasis including candidemia and esophageal candidiasis in adult patients.
23.02.09
28
Hydroquinone 2%+ Tretinoin 0.05% +
Hydrocortisone1%Cream
For the treatment of patients with skin hyperpigmentation
23.02.09
29
Doxyphylline 400 mg + Terbutaline 5mg tablets
For the treatment of asthma and chronic obstructive pulmonary disease
in adult patients only
23.02.09
30
Hydroquinone 20mg + Tretinoin 0.25mg +
Fluocinolone Acetonide 0.1mg per gm Cream
For the treatment of melasma of face in adults
23.02.09
31
Ketoconazole 2% + Zinc Pyrithone 1% Lotion
For the treatment of pityriasis and dandruff of the scalp
23.02.09
32
Lamivudine 30mg + Zidovudine 60mg + Nevirapine 50mg Oral Suspension (Tablets for oral
Suspension)
For the treatment of HIV patients
23.02.09
33
Glibenclamide 5mg + Pioglitazone 15mg + Metformin500mg
film coated tablets
As 3rd line treatment of type II diabetes mellitus when diet, exercise
and the single agents and the second line therapy with two drugs do not
result in adequate glycemic control
23.02.09
34
Aceclofenac 100mg + Tizanidine 2mg film coated tablets
For the treatment of acute low back pain in adult patients only
23.02.09
35
Octinoxate 7.5% + Avobenzone 3% + Oxybenzone 3% +
Titanium dioxide 2% lotion
As sunscreen lotion for prevention of sunburn skin
23.02.09
36
Cetrizine 5/10mg + Ambroxol 30mg per 5ml syrup
For the symptomatic relief of productive cough associated with
allergic rhinitis, when both anti-histamine and mucolytic agents are desired
23.02.09
37
Lidocaine Lozenges 200/300mg
For single agent anesthesia in upper gastro
intestinal endoscopy.
26.02.09
38
Calamine 8% + Liquid Paraffin10% lotion
As antipruritic and smoothening agent
26.02.09
39
Nifedipine 0.3% + Lidocaine1.5% cream
For the treatment of anal fissures
26.02.09
40
Quinapril 20mg + HCTZ 25mg film coated tablet
For the treatment of mild to moderate hypertension in adult patients
(in whom combination therapy is appropriate) who have been stabilized on the
individual components given in the same proportion
26.02.09
41
Levodopa 100/100/250 + Carbidopa 10/25/25mg mouth
dissolving tablet
For the symptomatic symptoms of idiopathic Parkinson's Disease
04.03.09
42
Paliperidone ER Tablets 1.5mg
Addl. Strength
04.03.09
43
Losartan 100mg+ HCTZ 25 mg tablet
Additional higher strength
16.03.09
44
Darunavir(as ethanolate) Tablet 300mg
For the treatment of human immunodeficiency virus (HIV) infection in
antiretroviral treatment experienced adult patients, such as those patients
with HIV-1 strains resistant to more than one protease inhibitor when
co-administered with 100mg ritonavir, and with
other antiretroviral agents.
19.03.09
45
Ropivacaine HCl Inj.2/5/7.5/10mg
For the production of local or regional anasthesia for surgery and for acute pain management.
19.03.09
46
Butaphosphan 100g + Methyl Hydroxybenzoate 1gm + Cyanocobalamin50 gm Oral powder
(Veterinary Drug)
As vitamin and phosphorous supplement for livestock, shirmp and fish.
19.03.09
47
Fluticasone furoate Nasal spray 27.5mcg per spray
For the treatment of symptoms of allergic rhinitis.
19.03.09
48
Octinoxate 7.5% + Avobenzone 2% + Oxybenzone 3% + Octocrylene 3%+ Zinc Oxide 2% lotion
A sunscreen lotion for prevention of sunburn skin
19.03.09
49
Omeprazole 20/40mg + Sodium Bicarbonate 600mg+ Magnesium Hydroxide 700mg sachet
Additional Strength
19.03.09
50
Ambroxol 30mg + Levo salbutamol 1mg+ Guiphenesin 50mg /5ml syrup
For the symptomatic relief of bronchospasm in bronchial asthma &
chronic bronchitis
19.03.09
51
Montelucast 4 mg+ Levocetrizine 2.5 mg tablet
Additional lower paedriatric dose
19.03.09
52
Surgical Sealant
To be indicated for use in sealing suture lines along arterial and
venous reconstructions.
26.03.09
53
Lidocaine Patch 700mg in aqueous base. (50 mg per gram adhesive)
For the relief of pain associated with post-herpetic neuralgia. It
should be applied only to intact skin.
26.03.09
54
Bimatoprost Opthalmic solution 0.03%
For the treatment of hypotrichosis of the eyelashes by increasing
their growth including length, thickness and darkness.
30.03.09
55
Trabectedin powder for concentrate for solution for infusion 1 mg/ vial
For the treatment of patients with advanced soft tissue sarcoma, after
failure of anthracyclines and ifosfamide,
or who are unsuited to recieve these agents.
30.03.09
56
Acebrophylline Syrup 10mg/ml (Additional Indication)
For the treatment of children (age 6to 12years) with chronic
obstructive pulmonary disease(COPD) and bronchial
asthma.
30.03.09
57
Mesalamine PR Tablets 1.2gm
For the induction of remission in patients with active, mild to
moderate ulcerative colitis.
30.03.09
58
Mycophenolate Mofetil Tablets 750mg Additional Strength
Same as approved
31.03.09
59
Ketorolac Tromethamine Gel 2%w/w
For the treatment of muscle, joint and post-traumatic stress.
31.03.09
60
Theophylline 400mg SR + Montelukast 10mg
Tablet
For the treatment of patients with bronchial asthma
31.03.09
61
Hyaluronic Acid Sodium Salt 0.2 gm + Silver Sulfadiazine 1.0 gm/25 gm tube
Hyaluronic Acid Sodium Salt 50 mg + Silver
Sulfadiazine 1.0 gm/ 100 gm gauze pads impregneted with cream.
For the treatment of wound of different etiology
31.03.09
62
Telmisartan 80mg + Amlodipine 5mg tablet
Additional higher strength
31.03.09
63
Hyaluronic Acid Sodium Salt
(i) Each 15gm tube contains: Hyaluronic Acid Sodium Salt 0.2gm/100gm
(ii) Sterile Gauze Pads impregnated with cream: Each gauze pad
contains Hyaluronic Acid Sodium Salt 50/100mg
For the treatment of wound of different etiology
31.03.09
64
Abatacept Injection 250mg/vial (additional indication)
For
reducing signs and symptoms of moderately to severly active polyarticular juvenile idiopathic arthritis/juvenile rheumatoid
arthritis in pediatric patients 6 years of age and
older who have had an inadequate response to one or more DMARD's such as MTX
10.04.09
65
Cetrizine 10 mg + Ambroxol 75 mg SR Tablet
For
symptomatic relief of productive cough associated with allergic rhinitis,
when both anti-histamine and mucolytic agents are desired
13.04.2009
66
Ciclesonide 200mcg + Formoterol 6mcg + Tiotropium 9mcg MDI
Indicated
as third line treatment of severe cases of COPD, when monotherapy and second line therapy with two drugs do not respond adequately.
13.04.2009
67
Each film
coated bilayred tablet contains: Metoprolol
25mg/50mg + Chlorthalidone 12.5mg
For the tretament of patients with mild to modrate essential hypertension
13.04.2009
68
Milnacipran 25/50mg Caps (Addl. Indication)
For
the management of fibromylagia.
15.04.2009
69
Lornoxicam SR 16mg Tabs
For
the symptomatic treatment of pain and inflammation in patients of
osteoarthritis & rheumatoid arthritis
25.04.2009
70
Palonosetron Hcl 0.075mg IV Inj (Addl. Strength)
Same
as approved
25.04.2009
71
Each film
coated bilayred tablet contains: Metoprolol
25mg/50mg + Chlorthalidone 6.25 mg /12.5mg
Additional
strength
25.04.2009
72
Albendazole 400 mg + Ivermectin 6 mg tablet
For the
treatment of intestinal helminthes and suppression
of microfilaraemia especially with bancrofti
infections
25.04.2009
73
Decitabine Lyophilized powder for injection 50mg/20ml vial
For
treatment of patients with myelodysplastic syndromes (MDS) including
previously treated and untreated, de novo and secondary MDS of all
French-American-British subtypes(refractory anemia,
refractory anemia with ringed sideroblasts,
refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic
myelomonocytic leukemia) and intermediate-1,
intermediate-2, and high-risk international Prognostic Scoring System groups.
25.04.2009
74
Retapamulin Ointment 1%
For the
topical treatment of bacterial skin and skin structure infections:- Primary impetigo, secondarily infected traumatic
lesions, secondarily infected dermatoses.
25.04.2009
75
Each ml
contains Calamine 15% w/v + Zinc oxide 5% w/v + Bentonite 3% w/v+ Glycerin 5%w/v + Sodium citrate 0.05 % w/v lotion
For the tretament of pruritis and
prickly heat
08.05.2009
76
Each 1000
ml of emulsion contains: Medium chain triglycerides 100 gm + Soya oil 80 gm +
Omega-3 acid triglycerides 20 gm + egg lecithin 12 gm + Glycerl 25 gm + Sodium oleate 0.30 gm + Alpha -tocopherol 0.20 gm + Ascorbypalmitate 0.30 gm + Sodium hydroxide max. 0.06 gm
+ water for injection 784 gm emulsion for infusion
For the
supply of fats, including essential omega-6 fatty acids and omega-3 fatty
acids, as part of a parenteral nutrition regimen in adults if oral or enteral nutrition is
impossible, inadequte or contraindicated.
14.05.2009
77
Sertaconazole Nitrate Powder 2% w/w & Lotion 2% w/v
For the
topical treatment of the superficial fungal infections of the skin.
02.05.2009
78
Amlodipine
Tablets 5mg/10mg (additional
indication)
1. To
reduce of fatal coronary heart disease and non-fatal myocardial infarction,
and to reduce the risk of stroke. 2. To
reduce the risk of coronary revascularization procedures and the need for
hospitalization due to angina in patients with coronary artery disease.
02.05.2009
79
Clindamycin
Phosphate Inj. 150mg/ml & Clindamycin HCl Capsules 150mg/300mg (additional indication)
Prophylaxis
of infection in neck and head surgery
02.05.2009
80
Each 15 gm
sachet contains: Lactulose 10 gm + Ispaghula husk
3.50 gm granules
For the
treatment of chronic idiopathic constipation in adult patients only
16.05.2009
81
Sucralose
for use as sweetner in drug formulations
09.05.2009
82
CarvedilolTablets 3.125/6.25/12.5/25mg (additional indication)
To reduce
cardiovascular mortality in clinically stable patients who have survived the
acute phase of a myocardial infarction and have a left ventricular ejection
fraction of ≤ 40% (with or without
symptomatic heart failure)
09.05.2009
83
Dexketoprofen 12.5 mg/25 mg + Paracetamol 500 mg film coated tablets
For the
treatment of Acute musculoskeletal pain
18.05.2009
84
Pregabalin SR Tablet 150/300mg
For the
treatment of peripheral neuropathic pain in adults
16.05.2009
85
Guaiphenesin ER Tablet 1200mg
For the
treatment of productive cough accompanied by Phlegm
16.05.2009
86
Everolimus 5/10mg Tablets (Addl. Indication)
Treatment
of advance renal cell carcinoma
16.05.2009
87
Nimesulide ER 200mg
(
Additional Indication)
Acute pain
in Orthopaedic, ENT, Dental and Post Operative condition
16.05.2009
88
Palonesetron Injection 0.25mg/5ml (Additional Indication)
For
treatment of Post Operative Nausea & vomiting
16.05.2009
89
Bendamustine Hydrochloride Lyophilized powder Injection 100mg/ vial
For the
treatment of patients with chronic lymphocytic leukemia.
16.05.09
90
Caffeine(as Citrate) 10mg / ml Injection
For the
short term treatment of apnoea of prematurity of infants between 28 and < 33
weeks gestational age.
16.05.09
91
Perindopril arginine 2.5mg/5mg/10mg film
coated tablet
For the
treatment of arterial hypertension, congestive heart failure and coronary
artery disease.
16.05.09
92
Each gm
contains: Halobetasol 0.05% w/w + Mupirocin 2.0 % w/w gel
For the
topical treatment of inflammatory dermatitis with secondry bacterial infection
16.05.09
93
Mometasone 0.1 % + Fusidic acid 2% cream/ointment
For the
treatment of dermatoses where secondry bacterial
and/or candidial infection is present
25.04.09
94
Thiocolchicoside 8 mg + Etoricoxib 60 mg tablets
Additional
strength
25.04.09
95
Methadone
Hydrochloride 5mg/10mg per ml syrup; 5mg/ 10mg/ 20mg / 40mg tablet
For the
treatment of opiod dependence and in maintainence treatment for opioid dependence.
28.05.09
96
Trospium Chloride film coated tablet
20mg
For the
treatment of overactive bladder with the symptoms of urge urinary
incontinence, urgency, and urinary frequency.
28.05.09
97
Arformoterol (as Tartrate ) 15mcg / 2ml Inhalation Solution
For the
long term, twice daily (morning and evening) maintainence treatment of bronchoconstriction in patients with chronic obstructive
pulmonary disease (COPD), including chronic bronchitis and emphysema.
29.05.09
98
Zolmitriptan...5.0%
w/v Benzalkonium Chloride NF ...
0.01% w/v Nasal spray
For the
acute treatment of migraine with or without aura in adults.
29.05.09
99
Dexmedetomidine ( as HCl) 100mcg /ml Injection
For
sedation of initially and mechanically ventilated patients during treatment
in an intensive care setting.
29.05.09
100
Levetiracetam SR Tablet 500/750/1000mg
same as approved
2.05.2009
101
Glatiramer Acetate Injection (20mg/ ml) & Pre-filled syringe (20mg/ml)
For the reduction of the
frequency of relapses in patients with Relapsing-Remitting Multiple
Sclerosis.
3.06.2009
102
Yttrium-90 Microspheres
Injection (Yttrium-90...3GBq (at the
time of calibration) per vial)
For the treatment of unresectable metastatic liver tumors from primary colorectal cancer with intra-hepatic artery chemotherapy (IHAC)
of FUDR (Floxuridine)
3.06.2009
103
Luliconazole Cream 1%
For the treatment of
cutaneous mycosis viz. Tinea pedis, Tinea corporis, Tinea cruris.
3.06.2009
104
Magnesium Valporate Prolonged release tablet 600mg
1) For the treatment of generelized or partial seizures as monothreapy or adjunctive threapy. 2) For prophylaxis of
migraine headache in adults. 3) For the treatment of manic episodes
associated with bi polar disorders
4.06.2009
105
Tenofovir Disoproxil Fumerate 300mg
For the treatment of
chronic Hepatitis B in adults
19.6.2009
106
Bosentan (as monohydrate) Tablets 62.5/125mg
For the treatment of
pulmonary arterial hypertension (WHO Group I) in patients with WHO Class III
or IV symptoms, to improve excercise ability and
decrease the rate of clinical worsening.
23.6.2009
107
Lornoxicam 12 mg SR (additional strength)
same as approved
26.6.2009
108
Azithromycin SR Granules for oral suspension 2000mg
for the treatment for mild
to moderate susceptible infection including RTI, uncomplicated skin/ skin
structure, non gonococcal urethritis, cervicitis
26.6.2009
109
Metoprolol 50/50/25 mg + Atorvastatin 20/10/10 mg + Ramipril 10/5/2.5 mg capsules
As 2nd line treatment of patients with
both essential hypertension and hypercholesterolemia who are not adequately
controlled by combination of an anti-hypertensive with lipid lowering agent.
1.07.2009
110
Methyl Phenidate ER Tablet 10/20/30mg
For the treatment of
Attention Deficit Hyperactivity Disorder (ADHD)
10.07.2009
111
Dasatinib Tablets 100mg (addl. Strength)
same as approved
10.07.2009
112
Voglibose 0.2 mg + Metformin 500mg Tablets
As 2nd line treatment of type II
Diabetes mellitus when diet, exercise and the single agent do not result in
adequate glycemic control.
13.7.2009
113
Combipack of artesunate tablet and FDC Tablet
of sulphadoxine + pyrimethamine Composition:
A. combipack of 1 stip of
3 tablets of artesunate 25 mg and 1 strip of 1
tablet of sulphadoxine 125mg+ pyrimethamine 6.25 mg
B. combipack of 1 stip of 3 tablets of artesunate 50 mg and 1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg
C. combipack of 1 stip of 3 tablets of artesunate 100 mg and 1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg
D. combipack of 1 stip of 3
tablets of artesunate 200 mg and 1 strip of 1 tablet
of sulphadoxine 500mg+ pyrimethamine 25 mg.
For the treatment of P.
falciparum resistant malaria patients
15.7.2009
114
Milnacipran 100mg (additional Strength)
same as approved
16.7.2009
115
Rifaximin 400mg (additional Indication)
For the treatment of
hepatic encephalopathy
18.7.2009
116
Nevirapine tablet 50 mg for oral suspension mg
For the treatment of HIV
infection in combination with other anti retro viral agents
18.7.2009
117
Desvenlafaxine (as Succinate) ER Tablets 50mg/100mg
For the treatment of major
depressive disorder (MDD)
18.7.2009
118
Posaconazole Oral Suspension 40mg/ml
For the treatment of
oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole. For prophylaxis of invasive Aspergillus and
Candida infections in patients, 13 years of age and older, who are at high
risk of developing these infections due to being severly immunocompromised, such as hematopoietic stem cell
transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those
with hematologic malignancies with prolonged neutropenia from
chemotherapy.
18.7.2009
119
Caffeine Citrate 20mg / ml
(equivalent to 10mg of Caffeine base) Oral Solution (Addl. Dosage form)
same as approved
18.7.2009
120
Amphotericin B Emulsion
5mg/ml (Addl. Indication)
Febrile Neutropenia in
cancer patients
18.7.2009
121
Hydroxy ethyl starch 10%
Solution for infusion
For the treatment of
imminent or manifest hypovolemia and shock.
18.7.2009
122
Naratriptan (as HCl) Tablets 1/ 2.5mg
For the acute treatment of
migraine with or without aura in adults.
18.7.2009
123
Colistimethate Sodium
powder for solution for injection/infusion 500000IU and 2000000IU (additional
Strength)
same as approved
20.7.2009
124
Simvastatin 20 mg + Ramipril 5mg + Atenolol 50 mg + HCTZ 12.5 mg + Aspirin
100 mg (EC Pellets) Capsules
For secondary prevention of coronory heart disease/stroke in patients where use of
such combination is appropriate
21.7.2009
125
Colistimethate Sodium
powder for solution for inhalation 500000IU/1000000IU/2000000IU
Treatment by inhalation of
Pseudomonas aeruginosa lung infection in patients with cystic fibrosis
28.7.2009
126
Ramipril MR capsule 10mg
For the treatment of
hypertension/ cardiac failure and myocardial infarction
30.7.2009
127
Abacavir
Sulfate Tablet 60mg
For
the treatment of HIV-1 infection in combination with other antiretroviral
agents
1.08.2009
128
Zoledronic
Acid Solution for Infusion Addl. Indication
Prevention
of clinical fractures after hip fracture in men and women
1.08.2009
129
Sumatriptan
85 mg + Naproxen 500 mg Tablets
Additional
Strength
for the treatment of migraine
3.08.2009
130
Aceclofenac(100mg)
+ Thiocolchicoside ( 8 mg) tablets
For
the treatment of acute inflammation conditions associated with spasm in adults
only
3.08.2009
131
Oxcarbazepine
150/300/600mg Tablet (Addl. Indication
Treatment
of generalized tonic-clonic seizures in adults and children
13.08.2009
132
Ofloxacin
2mg + Ornidazole 5 mg
per ml Infusion
for
the treatment of diarrhoea of mixed infection in adult patients
17.08.2009
133
Clozapine
Tablet200mg (Addl. Strength)
Indicated
in the management of Schizophrenic patients
19.08.2009
134
Oxymetazoline
Hydrochloride Nasal Spray50mcg/0.05%w/w
Is
indicated for the relief of stuffy,running nose associated with colds and
influenza, also post nasal drip, sinusitis.
19.08.2009
135
Enoxaparin
Sodium Injection (Addl.Indication)
Treatment
of acute ST-segment elevation myocardial infarction including patients to be
managed medically or with subsequent percuaneous coronary intervention (PCI)
19.08.2009
136
Fluvoxamine
Maleate100/150mg ER Tablets
For
the treatment of obsessive compulsive disorder (OCD)and depression
19.08.2009
137
Lidocaine
Lozenges 200/300mg (Addl. Indication)
For
single agent anesthesia in procedure involving the introduction of instrument
& tubes into respiratory tract.
19.08.2009
138
Risperidone
long acting injection (Addl. Indication)
Indicated
as monotherapy or as adjunctive therapy in lithium
or valproate for the maintenance treatment of Bipolar-1 disorder.
29.08.2009
139
Exemestane
25mg Tablet (Addl. Indication)
Indicated
for adjuvant treatment of Post Menopausal Women with estrogen receptor
positive early breast cancer who have received two-three year of tamoxifen and
are switched to exemestane for completion of total of five years of adjuvant
hormonal therapy.
29.08.2009
140
Artesunate (25/50/100mg) + Amodiaquine (67.5 mg/135/270mg) bilayerd Tablets
For the treatment of uncomplicated malaria due to plasmodium falciparum strain in various age groups
01.09.2009
141
Ezetimibe 10 mg + Fenofibrate 145 mg Film coated tablets
For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function
01.09.2009
142
Buprenorphine Transdermal Patch Each Transdermal Patch having an area of 6.25cm², 12.5cm², and 25cm²contains: Buprenorphine…5mg/10mg/20mg having release rate of 5mcg, 10mcg, 20mcg Buprenorphine per hour respectively(over a period of 7 days).
For the treatment of severe opioid responsive painconditions which are not adequately responding to non-opioid analgesics.For Hospital supply only.
03.09.09
143
Trospium Chloride ER Capsules 60 mg
For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency and urinary frequency.
04.09.2009
144
Metoclopramide (as HCl) 200mg / 400mg per ml Intranasal Solution
For the treatment of nausea and vomiting.
09.09.09
145
Isosorbibe 20 mg + Hydralazine 37.5 mg tablets
For the treatment of heart failure as an adjunct to standard therapy in patients to improve survival, to prolong time to hospitalization for heart failure and to improve patients reported functional status.
18.09.2009
146
Cefixime 200 mg + Dicloxacillin ER 500 mg Tablets
For the treatment of adult patients with Upper and Lower respiratory tract infections, skin and soft tissue infections
22.09.2009
147
Chlorthalidone Tablet 6.25mg
For the treatment of mild to moderate hypetension.
03.10.09
148
Cefovecin( as sodium) 80mg/ ml Lyophilised powder for injection (Veterinary)
For the treatment of skin bacterial infections in dogs and cats.
03.10.09
149
Imidacloprid 10% + Moxidectin 1.0% & 2.5% Topical solution (Veterinary) Each pippette contains: (a) 0.4ml, 1.0ml, 2.5ml, 4ml of 10% Imidacloprid and 1.0% moxidectin (b) 0.4ml, 0.8ml of 10% Imidacloprid and 2.5% moxidectin
For the treatment and prevention of flea infestations, prevention of heartworm disease and treatment of infections with gastrointestinal nematodes in dogs and cats.
03.10.09
150
Saxagliptin (as HCl) 2.5mg/ 5mg Tablets
As an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. (It should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
24.10.09
List of Approved Drug for Marketing in India
(from 01.01.2009 to 30.12.2009)
| S.No. | Drug Name | Indication | Approval Date |
| 1 | Zoledronic Acid Injection 5mg/100ml (Addl. Indication)
|
For the treatement of osteoporosis in
post-menopausal women and in men who are at increased risk of fracture,including those with a
recent low-trauma hip fracture.
|
07.01.09
|
| 2. | Misoprostol Tablet 600mcg
|
Addl. Strength
|
09.01.09
|
| 3 | Acebrophylline Syrup 10mg/ ml
|
For the treatement of adult patients with
chronic obstructive pulmonary disease(COPD) and
bronchial asthma.
|
09.01.09
|
| 4 | Selamectin Tropical solution (for verterinary use.)
60mg/120mg per ml
|
(I) For the treatement and lasting
prevention of flea infestations,treatment and
control of flea allergy dermatitis, prevention of heartworm disease,treatement and prevention of ear mites in dogs
and cats;
(II) For the treatement and prevention of sarcoptic mange,roundworms and for control of tick infestations in dogs.
|
09.01.09
|
| 5 | Methylcobalamin1500mcg + Calcium 200mg + Calcitriol 0.25mcg + Folic Acid1.5mg + Pyridoxine3mg Capsules
|
For the treatment of vitamin deficiency states in adults
|
14.01.09
|
| 6 | Metoprolol tartrate tablets 50 mg (Addl. Indication)
|
Adjunct to the treatement of Hyperthyroidism
|
14.01.09
|
| 7 | Cinacalet (as HCl) Tablet 30/60/90mg
|
For the treatment of secondary hyper parathyroidism in patients with chronic kidney diseases (CKD) on dialysis and for
hypercalcemia in patients with parathyroid carcinoma
|
14.01.09
|
| 8 | Mycophenolate mofetil Capsules 250mg, Tablets 500mg, Oral
suspension 200mg/ml (addl. Indication)
|
For the prophylaxis of acute organ rejection in patients recieving allogenic hepatic transplantation.
|
23.01.09
|
| 9 | Liquid Paraffin1.25ml + Milk of Magnesia 3.75ml + Sodium Picosulphate 3.33mg per 5ml
|
For symptomatic treatment of constipation in adults
|
29.01.09
|
| 10 | Ranolazine 1000mg ER Tabs (Additional Strength)
|
Same as approved
|
31.01.09
|
| 11 | Hyaluronic acid (cross linked) Pre-filled syringe 18mg/0.6ml and 24mg/0.8ml
|
For intradermal implantation and facial soft tissue augmentation
|
31.01.09
|
| 12 | Caspofungin acetate Injection (Addl. Indication)
|
For use in following: (I) Empirical therapy for presumed fungal
infections in febrile neutropenic patients.
(II) Treatment of Candidemia and the
following Candida infections: Intra-abdominal abscesses, Peritonitis and
Pleural space infections.
(III) Treatment of Esophageal Candidiasis.
(IV) Treatment of invasive Aspergillosis in patients who are
refractory to or intolerant of other therapies (i.e,
amphotericin B, lipid formulations of amphotericin B, and/or itraconazole)
|
31.01.09
|
| 13 | Micafungin ( as sodium) Powder for solution for infusion 50mg / vial
|
For the treatment of patients with candidemia,
acute disseminated candidiasis, candida peritonitis, abscess and esophageal candidiasis.
For the prophylaxis of Candida infection in patients undergoing hematopoietic
stem cell transplantation (HSCT)
|
31.01.09
|
| 14 | Loteprednol Etabonate Nasal spray 0.1% w/v
|
For prophylaxis and treatment of the nasal symptoms of seasonal
allergic rhinitis.
|
31.01.09
|
| 15 | Rasagiline (as mesylate ) Tablet 0.5mg/1mg
|
For the tratment of signs and symptoms of
idiopathic Parkinson's disease as intial monotherapy and as an addition to levodopa.
|
31.01.09
|
| 16 | Nicotine Polacrilex Gum 2mg & 4mg (Addl.
Indication)
|
To reduce the withdrawal symptoms, including nicotine craving,
associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco.
|
03.02.09
|
| 17 | Closantel Injection100mg/ ml (for verterinary use.)
|
For the infestation of trematodes, nematodes, cestodes and arthropods
of domestic animals, including milch and other food
producing animals.
|
05.02.09
|
| 18 | Lornoxicam 4mg + Paracetamol 500mg film coated tablets
|
For the short term use in acute painful & inflammatory conditions
in adults
|
05.02.09
|
| 19 | Cetrimide15% w/v + Chlorhexidine Gluconate 7.5% v/v + Isopropyl Alcohol
7.5% v/v Concentrate Solution
|
For cleansing of physically contaminated wounds and for pre-operative
disinfection
|
09.02.09
|
| 20 | Ketoconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) Solution
|
For the treatment of dandruff
|
09.02.09
|
| 21 | Doripenem (as monohydrate) Injection 250mg/500mg
|
For the treatment of nosocomial pneumonia in adults.
|
16.02.09
|
| 22 | Halobetasol Scalp Approved 0.05% w/v
|
For the relief of inflammatory and puritic manifestation of corticosteroid respensive dermatosis
|
18.02.09
|
| 23 | Nicotine (as Polacrilex) Lozenges 2mg &
4mg
|
To reduce the withdrawal symptoms, including nicotine craving,
associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco.
|
18.02.09
|
| 24 | Tranexamic Acid Tab SR 750mg
|
For the treatment of menorrhagia
|
20.02.09
|
| 25 | Betahistine Mesilate Tablet 6mg/12mg
|
For the treatment of dizziness and feeling of dizziness resulting from
Meniere's disease, Meniere's syndrome and vertigo.
|
20.02.09
|
| 26 | Abatacept Injection 250mg/vial (Addl. Indication)
|
In moderately to severly active rheumatoid arithritis in adults and may be used as monotherapy or concomitantly with DMARD's other than TNF
antagonists
|
20.02.09
|
| 27 | Anidulafungin Injection (Lyophilized powder) 50mg/100mg per vial
|
For the treatment of invasive candidiasis including candidemia and esophageal candidiasis in adult patients.
|
23.02.09
|
| 28 | Hydroquinone 2%+ Tretinoin 0.05% +
Hydrocortisone1%Cream
|
For the treatment of patients with skin hyperpigmentation
|
23.02.09
|
| 29 | Doxyphylline 400 mg + Terbutaline 5mg tablets
|
For the treatment of asthma and chronic obstructive pulmonary disease
in adult patients only
|
23.02.09
|
| 30 | Hydroquinone 20mg + Tretinoin 0.25mg +
Fluocinolone Acetonide 0.1mg per gm Cream
|
For the treatment of melasma of face in adults
|
23.02.09
|
| 31 | Ketoconazole 2% + Zinc Pyrithone 1% Lotion
|
For the treatment of pityriasis and dandruff of the scalp
|
23.02.09
|
| 32 | Lamivudine 30mg + Zidovudine 60mg + Nevirapine 50mg Oral Suspension (Tablets for oral
Suspension)
|
For the treatment of HIV patients
|
23.02.09
|
| 33 | Glibenclamide 5mg + Pioglitazone 15mg + Metformin500mg
film coated tablets
|
As 3rd line treatment of type II diabetes mellitus when diet, exercise
and the single agents and the second line therapy with two drugs do not
result in adequate glycemic control
|
23.02.09
|
| 34 | Aceclofenac 100mg + Tizanidine 2mg film coated tablets
|
For the treatment of acute low back pain in adult patients only
|
23.02.09
|
| 35 | Octinoxate 7.5% + Avobenzone 3% + Oxybenzone 3% +
Titanium dioxide 2% lotion
|
As sunscreen lotion for prevention of sunburn skin
|
23.02.09
|
| 36 | Cetrizine 5/10mg + Ambroxol 30mg per 5ml syrup
|
For the symptomatic relief of productive cough associated with
allergic rhinitis, when both anti-histamine and mucolytic agents are desired
|
23.02.09
|
| 37 | Lidocaine Lozenges 200/300mg
|
For single agent anesthesia in upper gastro
intestinal endoscopy.
|
26.02.09
|
| 38 | Calamine 8% + Liquid Paraffin10% lotion
|
As antipruritic and smoothening agent
|
26.02.09
|
| 39 | Nifedipine 0.3% + Lidocaine1.5% cream
|
For the treatment of anal fissures
|
26.02.09
|
| 40 | Quinapril 20mg + HCTZ 25mg film coated tablet
|
For the treatment of mild to moderate hypertension in adult patients
(in whom combination therapy is appropriate) who have been stabilized on the
individual components given in the same proportion
|
26.02.09
|
| 41 | Levodopa 100/100/250 + Carbidopa 10/25/25mg mouth
dissolving tablet
|
For the symptomatic symptoms of idiopathic Parkinson's Disease
|
04.03.09
|
| 42 | Paliperidone ER Tablets 1.5mg
|
Addl. Strength
|
04.03.09
|
| 43 | Losartan 100mg+ HCTZ 25 mg tablet
|
Additional higher strength
|
16.03.09
|
| 44 | Darunavir(as ethanolate) Tablet 300mg
|
For the treatment of human immunodeficiency virus (HIV) infection in
antiretroviral treatment experienced adult patients, such as those patients
with HIV-1 strains resistant to more than one protease inhibitor when
co-administered with 100mg ritonavir, and with
other antiretroviral agents.
|
19.03.09
|
| 45 | Ropivacaine HCl Inj.2/5/7.5/10mg
|
For the production of local or regional anasthesia for surgery and for acute pain management.
|
19.03.09
|
| 46 | Butaphosphan 100g + Methyl Hydroxybenzoate 1gm + Cyanocobalamin50 gm Oral powder
(Veterinary Drug)
|
As vitamin and phosphorous supplement for livestock, shirmp and fish.
|
19.03.09
|
| 47 | Fluticasone furoate Nasal spray 27.5mcg per spray
|
For the treatment of symptoms of allergic rhinitis.
|
19.03.09
|
| 48 | Octinoxate 7.5% + Avobenzone 2% + Oxybenzone 3% + Octocrylene 3%+ Zinc Oxide 2% lotion
|
A sunscreen lotion for prevention of sunburn skin
|
19.03.09
|
| 49 | Omeprazole 20/40mg + Sodium Bicarbonate 600mg+ Magnesium Hydroxide 700mg sachet
|
Additional Strength
|
19.03.09
|
| 50 | Ambroxol 30mg + Levo salbutamol 1mg+ Guiphenesin 50mg /5ml syrup
|
For the symptomatic relief of bronchospasm in bronchial asthma &
chronic bronchitis
|
19.03.09
|
| 51 | Montelucast 4 mg+ Levocetrizine 2.5 mg tablet
|
Additional lower paedriatric dose
|
19.03.09
|
| 52 | Surgical Sealant
|
To be indicated for use in sealing suture lines along arterial and
venous reconstructions.
|
26.03.09
|
| 53 | Lidocaine Patch 700mg in aqueous base. (50 mg per gram adhesive)
|
For the relief of pain associated with post-herpetic neuralgia. It
should be applied only to intact skin.
|
26.03.09
|
| 54 | Bimatoprost Opthalmic solution 0.03%
|
For the treatment of hypotrichosis of the eyelashes by increasing
their growth including length, thickness and darkness.
|
30.03.09
|
| 55 | Trabectedin powder for concentrate for solution for infusion 1 mg/ vial
|
For the treatment of patients with advanced soft tissue sarcoma, after
failure of anthracyclines and ifosfamide,
or who are unsuited to recieve these agents.
|
30.03.09
|
| 56 | Acebrophylline Syrup 10mg/ml (Additional Indication)
|
For the treatment of children (age 6to 12years) with chronic
obstructive pulmonary disease(COPD) and bronchial
asthma.
|
30.03.09
|
| 57 | Mesalamine PR Tablets 1.2gm
|
For the induction of remission in patients with active, mild to
moderate ulcerative colitis.
|
30.03.09
|
| 58 | Mycophenolate Mofetil Tablets 750mg Additional Strength
|
Same as approved
|
31.03.09
|
| 59 | Ketorolac Tromethamine Gel 2%w/w
|
For the treatment of muscle, joint and post-traumatic stress.
|
31.03.09
|
| 60 | Theophylline 400mg SR + Montelukast 10mg
Tablet
|
For the treatment of patients with bronchial asthma
|
31.03.09
|
| 61 | Hyaluronic Acid Sodium Salt 0.2 gm + Silver Sulfadiazine 1.0 gm/25 gm tube Hyaluronic Acid Sodium Salt 50 mg + Silver Sulfadiazine 1.0 gm/ 100 gm gauze pads impregneted with cream. |
For the treatment of wound of different etiology
|
31.03.09
|
| 62 | Telmisartan 80mg + Amlodipine 5mg tablet
|
Additional higher strength
|
31.03.09
|
| 63 | Hyaluronic Acid Sodium Salt
(i) Each 15gm tube contains: Hyaluronic Acid Sodium Salt 0.2gm/100gm
(ii) Sterile Gauze Pads impregnated with cream: Each gauze pad
contains Hyaluronic Acid Sodium Salt 50/100mg
|
For the treatment of wound of different etiology
|
31.03.09
|
| 64 | Abatacept Injection 250mg/vial (additional indication)
|
For
reducing signs and symptoms of moderately to severly active polyarticular juvenile idiopathic arthritis/juvenile rheumatoid
arthritis in pediatric patients 6 years of age and
older who have had an inadequate response to one or more DMARD's such as MTX
|
10.04.09
|
| 65 | Cetrizine 10 mg + Ambroxol 75 mg SR Tablet
|
For
symptomatic relief of productive cough associated with allergic rhinitis,
when both anti-histamine and mucolytic agents are desired
|
13.04.2009
|
| 66 | Ciclesonide 200mcg + Formoterol 6mcg + Tiotropium 9mcg MDI
|
Indicated
as third line treatment of severe cases of COPD, when monotherapy and second line therapy with two drugs do not respond adequately.
|
13.04.2009
|
| 67 | Each film
coated bilayred tablet contains: Metoprolol
25mg/50mg + Chlorthalidone 12.5mg
|
For the tretament of patients with mild to modrate essential hypertension
|
13.04.2009
|
| 68 | Milnacipran 25/50mg Caps (Addl. Indication)
|
For
the management of fibromylagia.
|
15.04.2009
|
| 69 | Lornoxicam SR 16mg Tabs
|
For
the symptomatic treatment of pain and inflammation in patients of
osteoarthritis & rheumatoid arthritis
|
25.04.2009
|
| 70 | Palonosetron Hcl 0.075mg IV Inj (Addl. Strength)
|
Same
as approved
|
25.04.2009
|
| 71 | Each film
coated bilayred tablet contains: Metoprolol
25mg/50mg + Chlorthalidone 6.25 mg /12.5mg
|
Additional
strength
|
25.04.2009
|
| 72 | Albendazole 400 mg + Ivermectin 6 mg tablet
|
For the
treatment of intestinal helminthes and suppression
of microfilaraemia especially with bancrofti
infections
|
25.04.2009
|
| 73 | Decitabine Lyophilized powder for injection 50mg/20ml vial
|
For
treatment of patients with myelodysplastic syndromes (MDS) including
previously treated and untreated, de novo and secondary MDS of all
French-American-British subtypes(refractory anemia,
refractory anemia with ringed sideroblasts,
refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic
myelomonocytic leukemia) and intermediate-1,
intermediate-2, and high-risk international Prognostic Scoring System groups.
|
25.04.2009
|
| 74 | Retapamulin Ointment 1%
|
For the
topical treatment of bacterial skin and skin structure infections:- Primary impetigo, secondarily infected traumatic
lesions, secondarily infected dermatoses.
|
25.04.2009
|
| 75 | Each ml
contains Calamine 15% w/v + Zinc oxide 5% w/v + Bentonite 3% w/v+ Glycerin 5%w/v + Sodium citrate 0.05 % w/v lotion
|
For the tretament of pruritis and
prickly heat
|
08.05.2009
|
| 76 | Each 1000
ml of emulsion contains: Medium chain triglycerides 100 gm + Soya oil 80 gm +
Omega-3 acid triglycerides 20 gm + egg lecithin 12 gm + Glycerl 25 gm + Sodium oleate 0.30 gm + Alpha -tocopherol 0.20 gm + Ascorbypalmitate 0.30 gm + Sodium hydroxide max. 0.06 gm
+ water for injection 784 gm emulsion for infusion
|
For the
supply of fats, including essential omega-6 fatty acids and omega-3 fatty
acids, as part of a parenteral nutrition regimen in adults if oral or enteral nutrition is
impossible, inadequte or contraindicated.
|
14.05.2009
|
| 77 | Sertaconazole Nitrate Powder 2% w/w & Lotion 2% w/v
|
For the
topical treatment of the superficial fungal infections of the skin.
|
02.05.2009
|
| 78 | Amlodipine
Tablets 5mg/10mg (additional
indication)
|
1. To
reduce of fatal coronary heart disease and non-fatal myocardial infarction,
and to reduce the risk of stroke. 2. To
reduce the risk of coronary revascularization procedures and the need for
hospitalization due to angina in patients with coronary artery disease.
|
02.05.2009
|
| 79 | Clindamycin
Phosphate Inj. 150mg/ml & Clindamycin HCl Capsules 150mg/300mg (additional indication)
|
Prophylaxis
of infection in neck and head surgery
|
02.05.2009
|
| 80 | Each 15 gm
sachet contains: Lactulose 10 gm + Ispaghula husk
3.50 gm granules
|
For the
treatment of chronic idiopathic constipation in adult patients only
|
16.05.2009
|
| 81 | Sucralose
|
for use as sweetner in drug formulations
|
09.05.2009
|
| 82 | CarvedilolTablets 3.125/6.25/12.5/25mg (additional indication)
|
To reduce
cardiovascular mortality in clinically stable patients who have survived the
acute phase of a myocardial infarction and have a left ventricular ejection
fraction of ≤ 40% (with or without
symptomatic heart failure)
|
09.05.2009
|
| 83 | Dexketoprofen 12.5 mg/25 mg + Paracetamol 500 mg film coated tablets
|
For the
treatment of Acute musculoskeletal pain
|
18.05.2009
|
| 84 | Pregabalin SR Tablet 150/300mg
|
For the
treatment of peripheral neuropathic pain in adults
|
16.05.2009
|
| 85 | Guaiphenesin ER Tablet 1200mg
|
For the
treatment of productive cough accompanied by Phlegm
|
16.05.2009
|
| 86 | Everolimus 5/10mg Tablets (Addl. Indication)
|
Treatment
of advance renal cell carcinoma
|
16.05.2009
|
| 87 | Nimesulide ER 200mg
(
Additional Indication)
|
Acute pain
in Orthopaedic, ENT, Dental and Post Operative condition
|
16.05.2009
|
| 88 | Palonesetron Injection 0.25mg/5ml (Additional Indication)
|
For
treatment of Post Operative Nausea & vomiting
|
16.05.2009
|
| 89 | Bendamustine Hydrochloride Lyophilized powder Injection 100mg/ vial
|
For the
treatment of patients with chronic lymphocytic leukemia.
|
16.05.09
|
| 90 | Caffeine(as Citrate) 10mg / ml Injection
|
For the
short term treatment of apnoea of prematurity of infants between 28 and < 33
weeks gestational age.
|
16.05.09
|
| 91 | Perindopril arginine 2.5mg/5mg/10mg film coated tablet | For the
treatment of arterial hypertension, congestive heart failure and coronary
artery disease.
|
16.05.09
|
| 92 | Each gm
contains: Halobetasol 0.05% w/w + Mupirocin 2.0 % w/w gel
|
For the
topical treatment of inflammatory dermatitis with secondry bacterial infection
|
16.05.09
|
| 93 | Mometasone 0.1 % + Fusidic acid 2% cream/ointment
|
For the
treatment of dermatoses where secondry bacterial
and/or candidial infection is present
|
25.04.09
|
| 94 | Thiocolchicoside 8 mg + Etoricoxib 60 mg tablets
|
Additional
strength
|
25.04.09
|
| 95 | Methadone
Hydrochloride 5mg/10mg per ml syrup; 5mg/ 10mg/ 20mg / 40mg tablet
|
For the
treatment of opiod dependence and in maintainence treatment for opioid dependence.
|
28.05.09
|
| 96 | Trospium Chloride film coated tablet
20mg
|
For the
treatment of overactive bladder with the symptoms of urge urinary
incontinence, urgency, and urinary frequency.
|
28.05.09
|
| 97 | Arformoterol (as Tartrate ) 15mcg / 2ml Inhalation Solution
|
For the
long term, twice daily (morning and evening) maintainence treatment of bronchoconstriction in patients with chronic obstructive
pulmonary disease (COPD), including chronic bronchitis and emphysema.
|
29.05.09
|
| 98 | Zolmitriptan...5.0%
w/v Benzalkonium Chloride NF ...
0.01% w/v Nasal spray
|
For the
acute treatment of migraine with or without aura in adults.
|
29.05.09
|
| 99 |
Dexmedetomidine ( as HCl) 100mcg /ml Injection
|
For
sedation of initially and mechanically ventilated patients during treatment
in an intensive care setting.
|
29.05.09
|
| 100 | Levetiracetam SR Tablet 500/750/1000mg
|
same as approved
|
2.05.2009
|
| 101 | Glatiramer Acetate Injection (20mg/ ml) & Pre-filled syringe (20mg/ml)
|
For the reduction of the
frequency of relapses in patients with Relapsing-Remitting Multiple
Sclerosis.
|
3.06.2009
|
| 102 |
Yttrium-90 Microspheres
Injection (Yttrium-90...3GBq (at the
time of calibration) per vial)
|
For the treatment of unresectable metastatic liver tumors from primary colorectal cancer with intra-hepatic artery chemotherapy (IHAC)
of FUDR (Floxuridine)
|
3.06.2009
|
| 103 |
Luliconazole Cream 1%
|
For the treatment of
cutaneous mycosis viz. Tinea pedis, Tinea corporis, Tinea cruris.
|
3.06.2009
|
| 104 |
Magnesium Valporate Prolonged release tablet 600mg
|
1) For the treatment of generelized or partial seizures as monothreapy or adjunctive threapy. 2) For prophylaxis of
migraine headache in adults. 3) For the treatment of manic episodes
associated with bi polar disorders
|
4.06.2009
|
| 105 | Tenofovir Disoproxil Fumerate 300mg
|
For the treatment of
chronic Hepatitis B in adults
|
19.6.2009
|
| 106 |
Bosentan (as monohydrate) Tablets 62.5/125mg
|
For the treatment of
pulmonary arterial hypertension (WHO Group I) in patients with WHO Class III
or IV symptoms, to improve excercise ability and
decrease the rate of clinical worsening.
|
23.6.2009
|
| 107 | Lornoxicam 12 mg SR (additional strength)
|
same as approved
|
26.6.2009
|
| 108 |
Azithromycin SR Granules for oral suspension 2000mg
|
for the treatment for mild
to moderate susceptible infection including RTI, uncomplicated skin/ skin
structure, non gonococcal urethritis, cervicitis
|
26.6.2009
|
| 109 |
Metoprolol 50/50/25 mg + Atorvastatin 20/10/10 mg + Ramipril 10/5/2.5 mg capsules
|
As 2nd line treatment of patients with
both essential hypertension and hypercholesterolemia who are not adequately
controlled by combination of an anti-hypertensive with lipid lowering agent.
|
1.07.2009
|
| 110 | Methyl Phenidate ER Tablet 10/20/30mg
|
For the treatment of
Attention Deficit Hyperactivity Disorder (ADHD)
|
10.07.2009
|
| 111 | Dasatinib Tablets 100mg (addl. Strength)
|
same as approved
|
10.07.2009
|
| 112 |
Voglibose 0.2 mg + Metformin 500mg Tablets
|
As 2nd line treatment of type II
Diabetes mellitus when diet, exercise and the single agent do not result in
adequate glycemic control.
|
13.7.2009
|
| 113 | Combipack of artesunate tablet and FDC Tablet of sulphadoxine + pyrimethamine Composition: A. combipack of 1 stip of 3 tablets of artesunate 25 mg and 1 strip of 1 tablet of sulphadoxine 125mg+ pyrimethamine 6.25 mg B. combipack of 1 stip of 3 tablets of artesunate 50 mg and 1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg C. combipack of 1 stip of 3 tablets of artesunate 100 mg and 1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg D. combipack of 1 stip of 3
tablets of artesunate 200 mg and 1 strip of 1 tablet
of sulphadoxine 500mg+ pyrimethamine 25 mg.
|
For the treatment of P.
falciparum resistant malaria patients
|
15.7.2009
|
| 114 | Milnacipran 100mg (additional Strength)
|
same as approved
|
16.7.2009
|
| 115 | Rifaximin 400mg (additional Indication)
|
For the treatment of
hepatic encephalopathy
|
18.7.2009
|
| 116 | Nevirapine tablet 50 mg for oral suspension mg
|
For the treatment of HIV
infection in combination with other anti retro viral agents
|
18.7.2009
|
| 117 | Desvenlafaxine (as Succinate) ER Tablets 50mg/100mg
|
For the treatment of major
depressive disorder (MDD)
|
18.7.2009
|
| 118 | Posaconazole Oral Suspension 40mg/ml
|
For the treatment of
oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole. For prophylaxis of invasive Aspergillus and
Candida infections in patients, 13 years of age and older, who are at high
risk of developing these infections due to being severly immunocompromised, such as hematopoietic stem cell
transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those
with hematologic malignancies with prolonged neutropenia from
chemotherapy.
|
18.7.2009
|
| 119 | Caffeine Citrate 20mg / ml
(equivalent to 10mg of Caffeine base) Oral Solution (Addl. Dosage form)
|
same as approved
|
18.7.2009
|
| 120 | Amphotericin B Emulsion
5mg/ml (Addl. Indication)
|
Febrile Neutropenia in
cancer patients
|
18.7.2009
|
| 121 | Hydroxy ethyl starch 10%
Solution for infusion
|
For the treatment of
imminent or manifest hypovolemia and shock.
|
18.7.2009
|
| 122 | Naratriptan (as HCl) Tablets 1/ 2.5mg
|
For the acute treatment of
migraine with or without aura in adults.
|
18.7.2009
|
| 123 | Colistimethate Sodium
powder for solution for injection/infusion 500000IU and 2000000IU (additional
Strength)
|
same as approved
|
20.7.2009
|
| 124 | Simvastatin 20 mg + Ramipril 5mg + Atenolol 50 mg + HCTZ 12.5 mg + Aspirin
100 mg (EC Pellets) Capsules
|
For secondary prevention of coronory heart disease/stroke in patients where use of
such combination is appropriate
|
21.7.2009
|
| 125 | Colistimethate Sodium powder for solution for inhalation 500000IU/1000000IU/2000000IU | Treatment by inhalation of
Pseudomonas aeruginosa lung infection in patients with cystic fibrosis
|
28.7.2009
|
| 126 | Ramipril MR capsule 10mg
|
For the treatment of
hypertension/ cardiac failure and myocardial infarction
|
30.7.2009
|
| 127 | Abacavir Sulfate Tablet 60mg | For the treatment of HIV-1 infection in combination with other antiretroviral agents | 1.08.2009 |
| 128 | Zoledronic Acid Solution for Infusion Addl. Indication | Prevention of clinical fractures after hip fracture in men and women | 1.08.2009 |
| 129 | Sumatriptan 85 mg + Naproxen 500 mg Tablets | Additional Strength for the treatment of migraine | 3.08.2009 |
| 130 | Aceclofenac(100mg) + Thiocolchicoside ( 8 mg) tablets | For the treatment of acute inflammation conditions associated with spasm in adults only | 3.08.2009 |
| 131 | Oxcarbazepine 150/300/600mg Tablet (Addl. Indication | Treatment of generalized tonic-clonic seizures in adults and children | 13.08.2009 |
| 132 | Ofloxacin 2mg + Ornidazole 5 mg per ml Infusion | for the treatment of diarrhoea of mixed infection in adult patients | 17.08.2009 |
| 133 | Clozapine Tablet200mg (Addl. Strength) | Indicated in the management of Schizophrenic patients | 19.08.2009 |
| 134 | Oxymetazoline Hydrochloride Nasal Spray50mcg/0.05%w/w | Is indicated for the relief of stuffy,running nose associated with colds and influenza, also post nasal drip, sinusitis. | 19.08.2009 |
| 135 | Enoxaparin Sodium Injection (Addl.Indication) | Treatment of acute ST-segment elevation myocardial infarction including patients to be managed medically or with subsequent percuaneous coronary intervention (PCI) | 19.08.2009 |
| 136 | Fluvoxamine Maleate100/150mg ER Tablets | For the treatment of obsessive compulsive disorder (OCD)and depression | 19.08.2009 |
| 137 | Lidocaine Lozenges 200/300mg (Addl. Indication) | For single agent anesthesia in procedure involving the introduction of instrument & tubes into respiratory tract. | 19.08.2009 |
| 138 | Risperidone long acting injection (Addl. Indication) | Indicated as monotherapy or as adjunctive therapy in lithium or valproate for the maintenance treatment of Bipolar-1 disorder. | 29.08.2009 |
| 139 | Exemestane 25mg Tablet (Addl. Indication) | Indicated for adjuvant treatment of Post Menopausal Women with estrogen receptor positive early breast cancer who have received two-three year of tamoxifen and are switched to exemestane for completion of total of five years of adjuvant hormonal therapy. | 29.08.2009 |
| 140 | Artesunate (25/50/100mg) + Amodiaquine (67.5 mg/135/270mg) bilayerd Tablets | For the treatment of uncomplicated malaria due to plasmodium falciparum strain in various age groups | 01.09.2009 |
| 141 | Ezetimibe 10 mg + Fenofibrate 145 mg Film coated tablets | For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function | 01.09.2009 |
| 142 | Buprenorphine Transdermal Patch Each Transdermal Patch having an area of 6.25cm², 12.5cm², and 25cm²contains: Buprenorphine…5mg/10mg/20mg having release rate of 5mcg, 10mcg, 20mcg Buprenorphine per hour respectively(over a period of 7 days). | For the treatment of severe opioid responsive painconditions which are not adequately responding to non-opioid analgesics.For Hospital supply only. | 03.09.09 |
| 143 | Trospium Chloride ER Capsules 60 mg | For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency and urinary frequency. | 04.09.2009 |
| 144 | Metoclopramide (as HCl) 200mg / 400mg per ml Intranasal Solution | For the treatment of nausea and vomiting. | 09.09.09 |
| 145 | Isosorbibe 20 mg + Hydralazine 37.5 mg tablets | For the treatment of heart failure as an adjunct to standard therapy in patients to improve survival, to prolong time to hospitalization for heart failure and to improve patients reported functional status. | 18.09.2009 |
| 146 | Cefixime 200 mg + Dicloxacillin ER 500 mg Tablets | For the treatment of adult patients with Upper and Lower respiratory tract infections, skin and soft tissue infections | 22.09.2009 |
| 147 | Chlorthalidone Tablet 6.25mg | For the treatment of mild to moderate hypetension. | 03.10.09 |
| 148 | Cefovecin( as sodium) 80mg/ ml Lyophilised powder for injection (Veterinary) | For the treatment of skin bacterial infections in dogs and cats. | 03.10.09 |
| 149 | Imidacloprid 10% + Moxidectin 1.0% & 2.5% Topical solution (Veterinary) Each pippette contains: (a) 0.4ml, 1.0ml, 2.5ml, 4ml of 10% Imidacloprid and 1.0% moxidectin (b) 0.4ml, 0.8ml of 10% Imidacloprid and 2.5% moxidectin | For the treatment and prevention of flea infestations, prevention of heartworm disease and treatment of infections with gastrointestinal nematodes in dogs and cats. | 03.10.09 |
| 150 | Saxagliptin (as HCl) 2.5mg/ 5mg Tablets | As an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. (It should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. | 24.10.09 |
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