The Drugs Controller General of India has given marketing approvals for 80 new drugs belonging to a wide range of therapeutic segments during the last nine months. The approvals included a large number of fixed dose combinations (FDCs) as the state drugs control authorities have stopped the practice of issuing FDC licenses.
The list of drugs approved since February 2005 and their pharmacological classification are: Diflorasone Diacetate Cream (0.5mg/gm) (for corticosteroid responsive dermatoses), Etonogestrel (11.7mg) + Ethinylestradiol (2.7mg) Contraceptive rings (For Contraceptive in women), Metaxalone (400mg) + Diclofenac Potassium (50mg) tablet (For acute painful musculoskeletal condition in adult), Tranexamic Acid (500mg) + Mefenamic acid (250mg) tablet (for primary dysmenorrhoea and pain associated with menorrhagia in women), Fluconazole (2%) + Zinc Pyrethione (1%) suspension (For seborrhoic dermatitis), Azelaic acid Cream (15%) (for the treatment of inflammatory papules and pustules of mild to moderate rosacea), Levodropropizine oral suspension (30mg/5ml) (For non-productive cough in adults ), Duloxetine HCl (60mg) tablet (additional strength), Desloratadine (2.5mg) + Ambroxol (30mg) +Guiphenasine (50mg) + Menthol 1mg/5ml Syrup, (For productive cough), Levofloxacin Ophthalmic Solution (0.5%) (For susceptible bacterial conjunctivitis), Metformin Oral Solution (100mg/ml) (For type-II diabetes mellitus), Tirofiban (0.25mg/ml injection) (additional strength) (For acute coronary syndrome including patients undergoing PTCA or atherectomy), Omeprazole (20mg) Enteric coated + Domperidone (30mg) (S.R.) capsule (for GERD not responding to Omeprazole), Stavudine powder for suspension (For HIV-1 infusion), Erdosteine (150mg/300mg) Capsules (For chronic obstructive bronchitis), Tazarotene (1mg) +Mometasone Furoate (1mg) per gram cream (for plaque psoriasis), Levetiracetam (250mg,500mg, 750mg) Tablets (as adjunctive therapy in treatment of partial onset seizures in adults with epilepsy), Esomeprazole Sodium For injection (for GERD in patients with esophagitis and/or severe symptoms of reflux as an alternative to oral therapy when oral intake is not appropriate), Rupatadine (10mg) tablet (For perinial allergic rhinitis), Acesulfame Potassium (As sweetener in pharmaceutical preparation), Buprenorphine (0.4mg) + Naloxone (0.1mg) sublingual tablet (For opioid dependence), Lamivudine (40mg) +Stavudine (10mg/5ml) reconstituted solution (for HIV infection), S(-) Metoprolol Succinate S.R. tablets (equivalent to S(-) Metoprolol Tartrate 12.5mg/25mg/50mg) (For Hypertension), R(-) Ondansetron (2mg/4mg) tablet (for chemotherapeutic induced nausea and vomiting), Balanced salt intra ocular irrigating solution enriched with glutathione Dextrose, bicarbonate (For intraocular irrigating during intraocular surgical procedures), Gliclazide M.R. (30mg/60mg)+ Metformin HCl (500mg) ER Tablet (For type-II diabetes), Drosperinone (3mg) + Ethinylestradiol (0.035mg tablet) (Oral Contraceptive), Simvastatin (10/20mg) + Ezetimibe (10mg) Tab (For primary Hypercholesterolemia), Ramipril (5mg) + Telmisartan (40mg) tablet (For Hypertension), Intralipid 30% (For patients with essential fatty acid deficiencies), Montelukast Granules (4mg/pack) (for Prophylaxis and chronic treatment of asthma in adult and pediatric patients of 12 months age and older), Bortezomib for injection (3.5mg/vial) (For the treatment of myeloma patients), Nelfinavir 625mg tablet (addl.strength) (for HIV patients), Sevelamer (400mg/800mg) tablet (For control of serum phosphorus in patients with chronic kidney disease and hemodialysis), S(-)Pantoprazole (10mg/20mg) tablet (For gastric ulcer, duodenal ulcer & GERD), Tazarotene (0.05%) + Mometasone Furoate (0.1%) Cream (addl.strength) (For Plaque psoriasis), R (-) Ondansetron oral Solution (1mg/5ml) (For Chemotherapy induced nausea and vomiting), Gatifloxacin (200mg) +Ornidazole (500mg) tablet (For diarrhoea of mixed infection in adults), Combikit of 2 tablet of Stavudine (40mg) + Lamivudine (150mg) each & 1 tablet of Efavirenz (600mg) (For HIV infection in adults), Combikit of 2 tablet of Lamivudine (150mg) + Zidovudine (300mg) each and 1 tablet of Egavirenz (600mg) (For HIV infection in adults), Aceclofenac gel 1.5% alongwith linseed oil, menthol, Salicylate, Capsaicin (For pain, swelling etc), Emtricitabine (200mg) capsule (For HIV infection in adults), Eplerenone Tablet (25mg/50mg) (For hypertension), Strontium Ranelate Granules (2gm/Sachet) (For post-menopausal women with Osteoporosis ), Lamivudine 30/60mg + Stavudine 6mg/12mg + Nevirapine 50mg/100mg dispersible tablet (For pediatric patients with HIV infection), Nitazoxanide (500mg) + Ofloxacin (200mg) Tablet (for urogenital infection in adults), Midazolam Maleate Bulk (Anesthetic), Calcium Polycarbophil (500mg) Tablet (IBS), FDC of Papain + Urea Ointment (For debriment of necrotic tissues), Testosterone Gel 1% (For replacement therapy in male with Testosterone deficiencies and hypogonadotropic hypogonadism), Erlotinib Hydrochloride (25mg/100mg/150mg Tablet (For metastatic non-small cell lung cancer), Chloroquine Phosphate eye drops (0.3mg/ml) ( For dry eye syndrome), Mecobalamine E.R. tablet (1500mcg) (For neuropathic pain), Olmesartan Medoxomil (5mg/20mg/40mg) Tablet (Anti-hypertension), Ursodeoxycholic Acid (500mg) S.R Tablet (Addl. Strength), FDC of Amlodipine (5mg) + Bisoprolol (2.5mg) (anti-hypertension), FDC of Ceftriaxone (500mg/100mg) + Tazobactum (12.5mg/62.5mg) Injection (Anti-bacterial), Feropenem Sodium (150mg/200mg) Tablet (anti-bacterial), Levodopa (50mg/100mg/150mg) + Carbidopa (12.5mg/25mg/37.5mg + Entacapone (200mg) tablet (For Parkinson's disease), Saquinavir (as mesylate) 500mg Tablet (Addl. Strength), Pramipexole Di-hydrochloride Tablet (0.125mg/0.25mg/0.5mg/1mg/1.5mg) (For Parkinson's disease), FDC of Atorvastatin (10mg) + Niacin (375mg/500mg E.R) Capsule (For Hypercholesterolemia), FDC of Levocetirizine (5mg) + Ambroxol (75mg S.R) Capsule (Anti-histaminic & mucolytic), FDC of Gabapentin (300mg) + Methylcobalamin (500mcg) Tablet (For neuropathic pain in adults), Phenytoin Sodium (300mg) tablet (Addl. Strength), FDC of Calciptriol (50mcg) + Betamethasone Dipro (0.5mg/gm) Ointment (For psoriasis vulgaris), FDC of Glimepiride (1mg/2mg) + Pioglitazone (15mg)+ Metformin (500mg E.R) Tablet (Anti-diabetic), Tenofovir Disoproxil Fumarate Tablet (300mg) (anti-HIV), sucralfate (7%) + Povidone Iodine (5%) Ointment (Anti-infective), Bivalirudin Injection (250mg/vial) (Anti-coagulant in PTCA), Efavirenz Oral Solution (30mg/ml) (Anti-AIDS), Didanosine Powder for oral solution (2gm/4gm per bottles) (Anti-AIDS), Sodium Valproate (750mg/1000mg) C.R. Tablet (addl. Strength), Oxcarbazepine S.R. (150mg/300mg/600mg) Tablet (Anti-epileptic), Acitretin (For sever psoriasis in adults), Dried IVY Leaf Extract (7.5gm/100ml) (Cough Syrup), Nimesulide 1% + Methyl Salicylate 5% (Aerosol For local application in acute pain), Feracrylum (1%) + Metronidazole 1%) (Antiseptic gel.), FDC of Methylcobalamin (1500mcg E.R) + Pyridoxine (20mg) + Folic Acid (5mg) Tablet (For hyper-homocysteinemia) and Trimebutine Maleate (For irritable bowel syndrome).