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List of Approved Drug for Marketing in India
(
from 01.01.2009 to 30.12.2009)

S.No.
Drug Name
Indication
Approval Date
1
Ferrous ascorbate 100mg + Folic acid 1.1 mg tablet and Omega-3-fatty acid 200mg capsules combikit
For iron, folic acid & omega-3-fatty acid deficiency 
08.01.10
2.
Sphaeranthus Indicus Extract Tablets
700mg
For the management of psoriasis
08.01.10
3
Febuxostat 40mg Additional Strength
Same As approved
16.01.10
4
Dexamethasone Intravitreal Implant 0.7mg
(in solid polymer drug delivery system)

For the treatment of macular edema following branch retinal vein occlusion (CRVO)

16.01.10
5
Buclizine Hcl 25mg Tablet (Additional
Indication)
For the Symptomatic treatment of various allergic conditions (rhinitis, conjunctivitis and urticaria) and for prevention and treatment of motion sickness
16-Jan-10
6
Pemetrexed Disodium 500mg/100mg
Powder for Injection (additional indication)
Indicated as a monotherapy for the maintenance treatment of locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.  First line treatment should be a platinum doublet with gemcitabine, paclitaxel or docetaxel.
16.01.10
7
Levobetaxolol HCl Opthalmic Suspension 0.5%
For lowering of intraoccular pressure in patients with chronic open-angle glaucoma or occular hypertension.
16.01.10
8
Sarpogrelate Hydrochloride film coated
Tablets 100mg
For the improvement of ischemic symptoms including ulcer, associated with chronic arterial occlusion.
16.01.10
9
Propanol 1-ol 18gm + Ethanol 100% 45gm/100ml solution
For hygenic and surgical hand disinfection
18.01.10
10
Aliskiren 150/160mg + Valsartan  300/320mg tablets
For the treatment of hypertension
19.01.10
11
Piroxicam 20mg tab& Paracetamol 500mg tab combikit 
For treatment of fever and pain associated with acute upper respiratory tract inflammation, acute musculoskeletal disorders, pain after operative intervetion and following trauma, chronic condition like rheumatoid arthritis, osteoarthritis etc for short term management of acute painful episodes.
19.01.10
12
Soybean oil 60gm + Triglycerides
(medium chain) 50gm + olive oil  purified
fish oil 30gm + dl-alpha-tocopherol 163-
225mg + glycerol (anhydrous) 25gm +
Egg lecithin 12gm + sodium hydroxide (to
approx pH 8) + sodium pleate 0.3mg
emulsion for infusion in 100ml.

Total parenteral nutrition following major abdominal, major thoracic or major urological surgery

19.01.10
13
Raltegravir (as Potassium) film coated Tablets 400mg
In combination with other anti retroviral agents for  the treatment of human immunodeficiency virus (HIV-1) infection in treatment experienced patients with evidence of HIV-1 replication despite ongoing retroviral therapy.
27.01.10
14
Deflazacort Tablet 18mg (Additional Strength)
Same as approved
30.01.10
15
Pregabalin SR tablet 75mg (Additional Strength)
Same as approved
30.01.10
16
Rivaroxaban film coated Tablets 10mg
For the prevention of venous thromboembolism in patients (VTE) in adult patients undergoing hip or knee replacement surgery.
30.01.10
17
Cinnarizine 20mg + Dimenhydrinate 40mg tablets 
For the treatment of vertigo
03.02.10
18
Lipid Based Amphotericin-B  Gel 0.1%
Indicated in the treatment of cutaneous and mucocutaneous mycotic infections caused by candida (Monilia) species.
05.02.10
19
Sodium Hyaluronate Injectable Gel 14mg/ml, 18mg/ml, 25.5mg/ml (Additional Strength)
Same as approved
06.02.10
20
Milnacipran Hcl 12.5mg (Addl. Strength)
Same as approved
06.02.10
21
Ropinirole 6mg ER Tablets (Addl. Strength)
Same as approved
6.02.10
22
Coseal Surgical Sealent 2/4/8ml (Addl. Indication)
(1)  Enforcement of suture and staple lines in lung resection procedures.                                     (2)Patients undergoing cardiac surgery to prevent or reduce the incidence, severity and extend of post surgical adhesion formation.                 (3)Patients undergoing laparotomy or laproscopic abdomino-pelvic surgery as an adjunct to good surgical technique intended to reduce the incidence, severity and extent of post surgical adhesion formation.
06.02.10
23
Pregabalin SR 75/150/300mg + Methylcobalamin 1500mcg tablets 
For the treatment of adult patients with peripheral neuropathy
09.02.10
24
Ivabradine Hcl Tablets 5/7.5mg (Additional Indication)
For Symptomatic Treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm, indicated in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is >60bpm.
10.02.10
25
Paracetamol Solution for Infusion (10mg/ml) in 50ml (Additional Packsize)
Same as approved
10.02.10
26
Ketorolac Tromethamine Ophthalmic Solution 0.45%
Indicated for the treatment of pain and inflammation following cataract surgery.
10.02.10
27
Cytarabine Injection 100mg Additional Packsize (20ml)
In combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children.  It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia.  Intrathecal administration of cytarabine is indicated in the prophylaxis and treatment of meningal leukemia.
10.02.10
28
Olopatadine Hcl Nasal Spray 0.6% w/w (Additional Indication)
For the relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older.
10.02.10
29
Sodium chloride 6.80gm + Potassium chloride 0.30 gm + Calcium chloride dihydrate 0.37gm  + Magnesium chloride  hexahydrate 0.20gm + Sodium acetate trihydrate 3.27gm + L-malic acid 0.67gm in 1000ml solution for infusion 
Replacement of extracellular fluid losses in case of isotonic dehydration, especially if acidosis is being imminent or present
11.02.10
30  
Chemically Modified Sodium Hyaluronate and Caboxymethylcellulose Absorbable Adhesion Barrier.
As an adjunct in abdominal or pelvic surgery for reducing the incidence, extent and severity of postoperative adhesions at the site of placement.
11.02.10
31
Lornoxicam 4mg/4mg + Thiocolchicoside 4mg/8mg tablets
For the treatment of patients with acute painful musculoskeletal conditions
12.02.10
32
Cefixime 100mg/200mg + Cloxacillin 500mg/500mg tablets
For the treatment of adult patients with upper & lower respiratory tract infections, skin and soft tissue infections
12.02.10
33
Celecoxib Mouth Dissolving Tablet 50/100/200 mg
For the Treatment of Osteoarthritis and Rheumatoid Arthritis
25.02.10
34
Propofol 2% w/v Injection (additionalStrength)
Same as Approved
27.02.10
35
Spironolactone 25mg + Furosemide 20mg tablets
For treatment of resistant oedema associated with secondary hyperaldosteronism; resistant hypertension, chronic cardic failure and hepatic cirrhosis
5.3.10
36
Olopatadine5mg + Ambroxol30mg tablets 
For the management of cough in adult patients only 
5.3.10
37
Methylcobalamin750mcg + Pregabalin75/150mg + Vitamin B61.5mg + Folic acid0.75mg + Benfothiamine7.5mg capsules
For the treaetment of painful diabetic neuropathy in adults only
5.3.10
38
Calcium acetate 435mg + Magnesium carbonate 235mg tablets
For the management of hyperphosphatemia in adults patients with renal failure being treated with dialysis (hemodialysis or peritoneal dialysis
5.3.10
39
Dicyclomine2.5mg + Dried Aluminimum Hydroxide200mg + Light Magnesium Oxide100mg + Simethicone 20mg per 5ml suspension.
For the treatment of the symptoms of functional gastrointestinal disorders like irratible bowel syndrome, functional dyspepsia, peptic ulcers., GERD which includes smooth muscle spasm, flatulence, abdominal distension, hyperacdity, gastric distress, bloting etc.
5.3.2010
40
Sertaconazole 2% w/v+ Zinc Pyrithione 1% w/v Shampoo
For the treatment in adults patients with dandruff/seborrheic dermatitis of the scalp
5.3.10
41
Faropenam Sodium Extended Release Tablet 225/300/450 mg
For the Treatment of respiratory tract infections, urinary tract infection, skin and skin structure infections and gynaecological infections
8.3.10
42
Amlodipine5mg + Ramipril10mg/5mg Tablets (additional strength)
For the treatment of hypertension only
10.3.10
43
Doxofylline MR Tablet 650 mg
For the treatment of Bronchial Asthma and COPD in Adults
11.3.10
44
Lidocaine7.5mg + Prilocaine2.5mg per acutation spray
For the treatment of adult male patients with premature ejaculation
12.3.10
45
Pramipexole Di HCl monohydrate ER Tablet 0.375/0.75/1.5/3/4.5 mg
For the treatment of the sign and symptoms of idiopathic parkinsons disease
13.3.2010
46
Drosperinone 3mg + Ethinyl Estradiol0.02mg tablets 
For the treatment of symptoms of premenstrual dysphoric disorders (PMDD) in women (additional indication)
16.3.10
47
Miglitol 25 mg + Metformin 500mg tablets
Additional Strength
16.3.2010
48
Propranolol 40mg (SR Pellets) + Fluarizine 5mg/10mg capsules 
For the prophylaxis of migraine
16.3.2010
49
Citicholine 500mg + Piracetam 400mg Tablets 
For the treatment of acute stroke 
16.3.2010
50
Diclofenac 50mg + Chlorzoxazone500mg Tablets
For the treatment of acute inflammation conditions associated with spasm in adults only
16.3.2010
51
Mecobalamin 750 mcg + Pyridoxine 1.5mg + Nicotinamide 45 mg + Benfotiamine 150mg Tablets
For the treatment of diabetic neuropathy in adults
16.3.2010
52
Etoricoxib 1%+ Menthol 5% Spray 
For the topical treatment of acute musculoskeletal pain
16.3.2010
53
Pantoprazole 40mg + Cinitapride (ER) 3mg Capsules
For the treatment of patients suffering from non-ulcer dyspepsia (NUD) or gasteroesophageal reflux disease (GERD)
17.3.2010
54
Atorvastatin 20mg + Ramipril 2.5mg/5mg Capsules 
Additional higher strength
17.3.2010
55
Lamotrigine Orodispersible Tablet 12.5 mg(additional strength)
Same as Approved
20.3.2010
56
Trabectedin powder for Conc. solution for infusion (Additional Indication)
In combination with pegylated liposomal doxorubicin, it is indicated for the treatment of patients with relapsed platinum- sensitive ovarian cancer
20.3.2010
57
Lornoxicam 8mg/8mg + Thiocolchicoside 4mg/8mg Tablets 
Additional higher strength
23.3.2010
58
Diclofenac sodium SR Tablet 150 mg
For the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondilytis,gout,painful post perative pain following dental surgery etc.
26.3.2010
59
Magnesium Valproate CR Tablet 200/ 300/400/ 500 mg (additonal strength)
Same as Approved 
26.3.2010
60
Lidocaine 2.5% w/w+Prilocaine 2.5% w/w Gel
Additional higher Strength
26.3.2010
61
Nicotinic Acid and Laropiprant Modified Release Tablets: Nicotinic Acid.........1000 mg
Laropiprant...........20mg
1. For the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDl-cholesterol) and in patients with primary hypercholesterolemia (heterozygous familial and non-familial).
2. In combination with HMG-CoA reductase inhibitors (statins), when cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated. Diet or other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy.
26.3.2010
62
Pantoprazole Mouth Dissolving Tablet 20/40 mg
For the treatment of gastric ulcer, duodenal ulcer & gastroesophageal reflux disease (GERD).
30.3.2010
63
Praziquntel 175mg + Pyrantel 504mg + Febental 525mg Tablets 
For the treatment of mixed infections with roundworms and tapeworms in dogs 
30.3.2010
64
Difluprednate Opthalmic Emulsion 0.05% w/v
For the treatment of inflammation and pain 
associated with ocular surgery. 
30.3.2010
65
Tolperisone Hcl SR 450mg Tablets
For the relief of painful muscle spasms of the skeletal muscualture.
31.3.2010
66
S(-)Metoprolol 25mg/50mg (ER) + Atorvastatin (IR)10mg tablets
For the treatment of patients with both essential hypertension and hypercholesterolemia
1.4.2010
67
Atorvastatin10mg + Ramipril 5mg + Aspirin (EC pellets) 75mg/150mg + Metoprolol (ER tablets) 25mg Capsules
For secondary prophylaxis of ischemic heart disease in patients where use of such combinations in appropriate 
5.4.2010
68
Lamotrigine 25mg Modified Release Tablet (Addl. Strength)
Same as Approved
5.4.2010
69
Imatinib Mesylate 100/400mg Tablets (Addl. Indication)
Adjuvant treatment of adult patients following resection of gastro-intestinal stromal tumours (GIST)
5.4.2010
70
Azithromycin SR Granules for Oral Suspension 1gm (Addl. Strength)
Same as Approved
5.4.2010
71
Gemfibrozil Capsule USP & Gemfibrozil Tablet USP 200mg/600mg (Addl. Indication)
For the treatment of other dyslipidemias: (a) Fredrickson Types III and V.(b) Associated with diabetes.(C) Associated with xanthomata.
5.4.2010
72
Ibuprofen 400mg + Chlorzoxazone 500mg Tablets
For the short term treatment of musculoskeletal pain associated with inflammation and spasm in adults only
7.4.2010
73
Doxophylline (SR) 400mg/800mg + Montelukast 10mg/10mg Tablets
For the treatment of bronchial asthma in adults
7.4.2010
74
Dronedarone( as Hydrochloride) film coated tablet .... 400 mg. 
To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age > 70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter > 50mm or left ventricular ejection fraction [LVEF] < 40%), who are in sinus rhythm or who will be cardioverted.
8.4.2010
75
Dosulepin Hcl Tablet 25mg/75mg (Additional Indication)
For the treatment of chronic pain.
8.4.2010
76
Prasugrel (as Hydrochloride) film coated tablet ....5 mg / 10mg.
To reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:
• Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI). 
• Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI.
13.4.2010
77
Tofisopam uncoated tablet JP... 50/100mg
For the treatment of anxiety and depression.
13.4.2010
78
Zotepine tablet ....25/50/100mg
For the treatment of schizophrenia
15.4.2010
79
Armodafinil uncoated tablet ..50/150/250mg
To improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder (SWD) or narcolepsy.
23.4.2010
80
Indacaterol ( as Maleate ) Inhalation Powder Hard Capsules ….. ...150/300mcg
For maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
24.4.2010
81
Ranolazine ER Tablets 750mg (Additional Strength)
Same as Approved
24.4.2010
82
Tacrolimus Capsules 3mg (Additional Strength)
Same as approved
24.4.2010
83
Cefixime 100mg/200mg + Ofloxacin 100mg/200mg Tablets
For the treatment of patients with typhoid fever and urinary tract infection in adults 
26.4.2010
84
Liquid paraffin 6% + White soft paraffin 15%w/v Cream 
For symptomatic relief of dermatological condition associated with dry skin including atopic dermatitis, eczema, pruritus, ichthyosis, xerosis, psoriasis
29.4.2010
85
Levosimendan Injection 2.5mg / ml
For the short term treatment of acutely decompensated chronic heart failure (ADHF) in situations where conventional therapy is not sufficient and in cases where ionotropic support is considered appropriate.
30.4.2010
86

Thiocolchicosde

SR Tablet 16mg

As an adjuvant treatment in
painful
spasms associated with
degenerative vertebral
disorders
and vertebral static problems,
torticollis dorsal pain,
low back
pain, traumatological and
neurological disorders.
31.4.2010
87
Telmisartan 40/80 mg+ Indapamide SR 1.5/1.5 mg tablet 
For the treatment essential hypertension 
04.05.2010
88
one strip of 3 uncoated tablets of artesunate 150mg & one strip of 2 uncoated tablets of FDC of Sulphadoxine IP 500mg + Pyrimethamine IP 25mg 
Additional strength 
04.05.2010
       
       

 


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