LIST OF DRUGS APPROVED DURING 2005

S.No 267 268 269 270 271 Name Of Drug Centbucridine (0.5%) + Feracrylem (3%) Atenolol (25mg, 50mg) + HCTZ (12.5mg) Levocetirizine Syrup (2.5mg/5ml) Pitavastatin (1mg/2mg) Tablet Ofloxacin (200mg) + Ornidazole (500mg) Pharmacological Classification For hemorrhoid & anal fissure Anti-Hypertensive For allergic rhinitis & urticaria Lipid Lowering agent For diarrhea of mixed infection For alteration of intestinal bacterial flora Anti-HIV. Date of Approval 11-012005 13-012005 13-012005 14-012005 20-012005 28-012005 28-012005 08-022005 15-022005 22-022005 22-022005 22-022005 23-022005 25-022005 28-022005 02-032005 04-032005 04-032005

Bacillus calusii spores suspension (2billion/5ml vial) 272 Lamivudine (40mg) +Nevirapine (70mg 273 +Stavudine (10mg) (in 5ml) powder for suspension 274 Diflorasone Diacetate Cream (0.5mg/gm)

For corticosteroid responsive dermatoses Etonogestrel (11.7mg) + Ethinylestradiol (2.7mg) For Contraceptive in women 275 Contraceptive rings Metaxalone (400mg) + Diclofenac Potassium 276 (50mg) tablet Tranexamic Acid (500mg) + Mefenamic acid 277 (250mg) tablet 278 279 280 281 Levodropropizine oral suspension (30mg/5ml) Duloxetine HCl (60mg) tablet (additional strength) Fluconazole (2%) + Zinc Pyrethione (1%) suspension Azelaic acid Cream (15%) For acute painful musculoskeletal condition in adult For primary dysmenorrhoea and pain associated with menorrhagia in women For seborrhoic dermatitis For the treatment of inflammatory papules and pustules of mild to moderate rosacea For non-productive cough in adults

Desloratadine (2.5mg) + Ambroxol (30mg) For productive cough +Guiphenasine (50mg) + Menthol 1mg/5ml Syrup 282 283 284 Levofloxacin Ophthalmic Solution (0.5%) Metformin Oral Solution (100mg/ml) For susceptible bacterial conjunctivitis For type-II diabetes mellitus

Tirofiban (0.25mg/ml injection) 285 (additional strength) Omeprazole (20mg) 286 Enteric coated + Domperidone (30mg) (S.R.) capsule 287 Stavudine powder for suspension Erdosteine (150mg/300mg) Capsules 288 Tazarotene (1mg) +Mometasone Furoate (1mg) 289 per gram cream Levetiracetam (250mg,500mg, 290 750mg) Tablets Esomeprazole Sodium For injection 291 Rupatadine (10mg) tablet Acesulfame Potassium

For acute coronary syndrome including patients undergoing PTCA or atherectomy For GERD not responding to Omeprazole.

09-032005 10-032005

For HIV-1 infusion For chronic obstructive bronchitis

11-032005

For plaque psoriasis

11-032005 01-042005

292 293

Buprenorphine (0.4mg) + Naloxone (0.1mg) 294 sublingual tablet Lamivudine (40mg) +Stavudine (10mg/5ml) 295 reconstituted solution S(-) Metoprolol Succinate S.R. tablets (equivalent 296 to S(-) Metoprolol Tartrate 12.5mg/25mg/50mg) 297 R(-) Ondansetron (2mg/4mg) tablet

As adjunctive therapy in treatment of 04-04partial onset seizures in adults with 2005 epilepsy. For GERD in patients with 04-04esophagitis and/or severe symptoms 2005 of reflux as an alternative to oral therapy when oral intake is not appropriate For perinial allergic rhinitis 05-042005 As sweetener in pharmaceutical 05-04preparation 2005 For opioid dependence 06-042005 For HIV infection For Hypertension 08-042005 15-042005 15-042005 26-042005 27-042005 11-052005 11-052005

Balanced salt intra ocular irrigating solution 298 enriched with glutathione Dextrose, bicarbonate Gliclazide M.R. (30mg/60mg)+ 299 300 301 Metformin HCl (500mg) ER Tablet

For chemotherapeutic induced nausea and vomiting For intraocular irrigating during intraocular surgical procedures For type-II diabetes

Drosperinone (3mg) + Ethinylestradiol (0.035mg Oral Contraceptive tablet) Simvastatin (10/20mg) + Ezetimibe (10mg) Tab For primary Hypercholesterolemia

Ramipril (5mg) + Telmisartan (40mg) tablet 302 303 304 305 Bortezomib for injection (3.5mg/vial) Nelfinavir 625mg tablet (addl.strength) 306 Intralipid 30% Montelukast Granules (4mg/pack)

For Hypertension For patients with essential fatty acid deficiencies For Prophylaxis and chronic treatment of asthma in adult and pediatric patients of 12 months age and older For the treatment of myeloma patients For HIV patients

11-052005 12-052005 17-052005 18-052005 20-052005

For control of serum phosphorus in patients with chronic kidney disease and hemodialysis. S(-)Pantoprazole (10mg/20mg) tablet For gastric ulcer, duodenal ulcer & 308 GERD Tazarotene (0.05%) + Mometasone Furoate (0.1%) For Plaque psoriasis 309 Cream (addl.strength) 307 For Chemotherapy induced nausea and vomiting Gatifloxacin (200mg) +Ornidazole (500mg) tablet For diarrhoea of mixed infection in 311 adults Combikit of 2 tablet of Stavudine (40mg) + For HIV infection in adults 312 Lamivudine (150mg) each & 1 tablet of Efavirenz (600mg) Combikit of 2 tablet of Lamivudine (150mg) + For HIV infection in adults Zidovudine (300mg) each and 1 tablet of 313 Egavirenz (600mg) 310 Aceclofenac gel 1.5% alongwith linseed oil, 314 menthol, Salicylate, Capsaicin 315 316 317 Emtricitabine (200mg) capsule Eplerenone Tablet (25mg/50mg) Strontium Ranelate Granules (2gm/Sachet) For pain, swelling etc For HIV infection in adults For hypertension For post-menopausal women with Osteoporosis For pediatric patients with HIV infection For urogenital infection in adults. Anesthetic IBS For debriment of necrotic tissues. R (-) Ondansetron oral Solution (1mg/5ml)

Sevelamer (400mg/800mg) tablet

20-052005 20-052005 24-052005 24-052005 06-062005 07-062005 07-062005 08-062005 09-062005 10-062005 14-062005 14-062005 30-062005 05-072005 06-072005 11-072005

Lamivudine 30/60mg + Stavudine 6mg/12mg + 318 Nevirapine 50mg/100mg dispersible tablet Nitazoxanide (500mg) + 319 Ofloxacin (200mg) Tablet 320 321 322 Midazolam Maleate Bulk Calcium Polycarbophil (500mg) Tablet FDC of Papain + Urea Ointment

Testosterone Gel 1%. 323 Erlotinib Hydrochloride (25mg/100mg/150mg Tablet Chloroquine Phosphate eye drops 325 (0.3mg/ml) Mecobalamine E.R. tablet (1500mcg) 326 324 327 328 329 330 331 332 333 Olmesartan Medoxomil (5mg/20mg/40mg) Tablet Ursodeoxycholic Acid (500mg) S.R Tablet FDC of Amlodipine (5mg) + Bisoprolol (2.5mg) FDC of Ceftriaxone (500mg/100mg) + Tazobactum (12.5mg/62.5mg) Injection Feropenem Sodium (150mg/200mg) Tablet Levodopa (50mg/100mg/150mg) + Carbidopa (12.5mg/25mg/37.5mg + Entacapone (200mg) tablet Saquinavir (as mesylate) 500mg Tablet

For replacement therapy in male with Testosterone deficiencies and hypogonadotropic hypogonadism For metastatic non-small cell lung cancer. For dry eye syndrome For neuropathic pain Anti-hypertension Addl. Strength Anti-hypertension Anti-bacterial Anti-bacterial For Parkinsons disease Addl. Strength. For Parkinsons disease For Hypercholesterolemia

12-072005

13-072005 13-072005 19-072005 21-072005 20-072005 21-072005 21-072005 21-072005 25-072005 25-072005 25-072005

Pramipexole Di-hydrochloride Tablet 334 (0.125mg/0.25mg/0.5mg/1mg/1.5mg). FDC of Atorvastatin (10mg) + Niacin 335 (375mg/500mg E.R) Capsule FDC of Levocetirizine (5mg) + Ambroxol 336 (75mg S.R) Capsule FDC of Gabapentin (300mg) + 337 Methylcobalamin (500mcg) Tablet Phenytoin Sodium (300mg) tablet 338

FDC of Calciptriol (50mcg) + 339 Betamethasone Dipro (0.5mg/gm) Ointment FDC of Glimepiride (1mg/2mg) + Anti-diabetic 340 Pioglitazone (15mg)+ Metformin (500mg E.R) Tablet Tenofovir Disoproxil Fumarate Tablet Anti-HIV 341 (300mg) Sucralfate (7%) + Povidone Iodine (5%) Anti-infective 342 Ointment 343 344 345 Bivalirudin Injection (250mg/vial) Efavirenz Oral Solution (30mg/ml) Didanosine Powder for oral solution (2gm/4gm per bottles)

26-072005 Anti-histaminic & mucolytic 29-072005 For neuropathic pain in adults. 05-082005 Addl. Strength 05-082005 For psoriasis vulgaris. 12-082005 12-082005 17-082005 18-082005 25-082005 25-082005 26-082005

Anti-coagulant in PTCA Anti-AIDS Anti-AIDS

Sodium Valproate (750mg/1000mg) C.R. Addl. Strength Tablet Oxcarbazepine S.R. Anti-epileptic 347 (150mg/300mg/600mg) Tablet Acitretin For sever psoriasis in adults. 348 346 349 350 351 Dried IVY Leaf Extract (7.5gm/100ml) Nimesulide 1% + Methyl Salicylate 5%. Feracrylum (1%) + Metronidazole 1%)

FDC of Methylcobalamin (1500mcg E.R) 352 + Pyridoxine (20mg) + Folic Acid (5mg) Tablet Ketorolac Tromethamine 0.4% Eye drops Ophthalmic 353 (addl. Strength) Levetiracetam Oral Solution (100mg/ml) Anti-epileptic 354 355 356 357 Zinc (Gluconate) oral solution (20mg/5ml) Trimebutine Maleate

26-082005 08-092005 09-092005 Cough Syrup 15-092005 Aerosol For local application 16-092005 in acute pain. Antiseptic gel. 16-092005 For hyper-homocysteinemia 16-092005 20-092005 22-092005 05-102005 10-102005 17-102005 25-102005 08-112005 09-112005 10-112005 10-112005 11-112005 11-112005 17-112005 21-112005 21-112005 22-112005 24-112005 25-112005

For acute diarrhoea For irritable bowel syndrome For Hypertension For influenzae Anti-histaminic For the treatment of hyperphosphatemia. For relief of productive cough. Ophthalmic use. For essential hypertension For HIV infection Anti-diabetic For the treatment of constipation. For Veterinary use. For dyspepsia, colicy pain & GERD. For Ophthalmic use. For neuropathic pain.

Enalapril (2.5mg/5mg) + HCTZ (12.5) Tablet (Addl. Strength) Oseltamivir (as phosphate) Capsule 358 (75mg) & oral suspension (12mg/ml) Cetirizine HCl drops (10mg/ml) 358 Lanthanum Carbonate Chewable tablet (250mg/500mg) Ambroxol HCl 75mg (S.R) + 360 Desloratadine 5mg Capsule. 359 Sodium Hyaluronate 0.1% eye drops (addl. Strength) FDC of S-Metoprolol Succinate Tartrate 362 equivalent to Metoprolol Tartrate (E.R) 25/50mg + HCTZ (12.5mg) Tablet. Stavudine 10mg+Lamivudine 40mg+ 363 Nevirapine 70mg dispersible tablet Voglibose (0.2mg/0.3mg) Tablet 364 361 365 366 367 Lactitol Sachet (10gm/20gm). Aspirin Bolus (Vet.) 6gm/bolus)

Domperidone (10mg) + Activaed dimethicone (125mg) chewable tablet Moxifloxacin (0.5%) + Dexamethasone 368 Phosphate (0.1%) Eye drops Pregabalin capsule (75/150/300mg) 369

Methotrexate Topical gel (1%) Addl. 370 Strength Brimonidine Tartrate (2mg/1.5mg) + 371 Timolol (as HCl) 5mg/ml. Testosterone Spray (25mg) 372 Omeprazole Powder for suspension (20mg/Sachet) Doxazosin (as Mesylate) 4mg/8mg E.R. 374 Tablet Amlodipine (as besylate) 5mg + 375 Bisoprolol 5mg Tablet (Addl. Strength) FDC of Olmesartan Medoxomil 376 (20mg/40mg/40mg) + HCTZ(12.5mg/12.5mg/25mg) Phenylephrine 2.5% Eye drops 377 373 Entecavir Tablet (0.5mg/1.0mg) & oral solution (0.05mg/ml). Ketorolac Tromethamine 5mg + 379 Ofloxacin 3mg/ml Eye drops 378 Hyoscine-N-Butylbromide (10mg) + Paracetamol 500mg Tablet Amlodipine (as besylate ) 5mg + 381 Losartan Pot. 50mg Travoprost Eye drops (40mcg/ml) 382 380

Psoriasis. Ophthalmic For replacement therapy in males with testosterone deficiency. Anti-ulcer For hypertension For hypertension For essential hypertension Ophthalmic For chronic Hepatitis-B infection. Ophthalmic For spasmodic pain For hypertension For glaucoma & ocular hypertension. For LRTI

25-112005 25-112005 29-112005 30-112005 30-112005 30-112005 02-122005 02-122005 05-122005 07-122005 08-122005 08-122005 08-122005 08-122005 15-122005 16-122005 21-122005 22-122005 23-122005

Ceftriaxone (as sodium) (500mg/1000mg) + Sulbactam (as 383 sodium) (250mg/500mg) powder for injection. Atomoxetine (as HCl) Sachet For ADHD 384 (10/18/25/40mg) Levofloxacin Oph. Solu. (1.5%) 15mg/ml. Ophthalmic 385 (Addl. Strength). Zonisamide (100mg) capsule Anti-epileptic 386 387 388 Methimazole Tablet ( 5mg/10mg) Caspofungin Acetate injection (50mg/70mg per vial).

For hyperthyroidism. For invasive candidiasis fungal infection.