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List of Approved Drug from 01.01.2010 to 31.12.2010

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List of Approved Drug from 01.01.2010 to 31.12.2010 LIST OF APPROVED DRUG FROM 01.01.2010 TO 31.12.2010 DATE OF S.N PRODUCT NAME INDICATION APPROVA O L Ferrous ascorbate 100mg + Folic For iron, folic acid & omega-3-fatty 1 acid 1.1 mg tablet and Omega-3- 08/01/2010 acid deficiency fatty acid 200mg capsules combikit Sphaeranthus Indicus Extract Tablets 2 For the management of psoriasis. 08/01/2010 700mg Febuxostat 40mg Additional 3 Same As approved 16/01/2010 Strength Dexamethasone Intravitreal Implant For the treatment of macular edema 4 0.7mg (in solid polymer drug following branch retinal vein 16/01/2010 delivery system) occlusion (CRVO) For the Symptomatic treatment of various allergic conditions (rhinitis, Buclizine Hcl 25mg Tablet 5 conjunctivitis and urticaria) and for 16/01/2010 (Additional Indication) prevention and treatment of motion sickness Indicated as a monotherapy for the maintenance treatment of locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell Pemetrexed Disodium histology in patients whose disease 6 500mg/100mg Powder for Injection 16/01/2010 has not progressed immediately (additional indication) following platinum-based chemotherapy. First line treatment should be a platinum doublet with gemcitabine, paclitaxel or docetaxel. For lowering of intraoccular Levobetaxolol HCl Opthalmic pressure in patients with chronic 7 16/01/2010 Suspension 0.5% open-angle glaucoma or occular hypertension. For the improvement of ischemic Sarpogrelate Hydrochloride film symptoms including ulcer, 8 16/01/2010 coated Tablets 100mg associated with chronic arterial occlusion. Propanol 1-ol 18gm + Ethanol 100% For hygenic and surgical hand 9 18/01/2010 45gm/100ml solution disinfection Aliskiren 150/160mg + 10 For the treatment of hypertension 19/01/2010 Valsartan 300/320mg tablets For treatment of fever and pain associated with acute upper respiratory tract inflammation, acute musculoskeletal disorders, Piroxicam 20mg tab& Paracetamol pain after operative intervetion and 11 19/01/2010 500mg tab combikit following trauma, chronic condition like rheumatoid arthritis, osteoarthritis etc for short term management of acute painful episodes. Soybean oil 60gm + Triglycerides (medium chain) 50gm + olive oil purified fish oil 30gm + dl- alpha-tocopherol 163-225mg + Total parenteral nutrition following 12 glycerol (anhydrous) 25gm + Egg major abdominal, major thoracic or 19/01/2010 lecithin 12gm + sodium hydroxide major urological surgery (to approx pH 8) + sodium pleate 0.3mg emulsion for infusion in 100ml. In combination with other anti retroviral agents for the treatment of human immunodeficiency virus Raltegravir (as Potassium) film 13 (HIV-1) infection in treatment 27/01/2010 coated Tablets 400mg experienced patients with evidence of HIV-1 replication despite ongoing retroviral therapy. Deflazacort Tablet 18mg (Additional 14 Same as approved 30/01/2010 Strength) Pregabalin SR Tablet 75mg 15 Same as approved 30/01/2010 (Additional Strength) For the prevention of venous Rivaroxaban film coated Tablets thromboembolism in patients 16 30/01/2010 10mg (VTE) in adult patients undergoing hip or knee replacement surgery. Cinnarizine 20mg + Dimenhydrinate 17 For the treatment of vertigo 03/02/2010 40mg tablets Indicated in the treatment of Lipid Based Amphotericin-B Gel cutaneous and mucocutaneous 18 05/02/2010 0.1% mycotic infections caused by candida (Monilia) species. Sodium Hyaluronate Injectable Gel 19 14mg/ml, 18mg/ml, 25.5mg/ml Same as approved 06/02/2010 (Additional Strength) Milnacipran Hcl 12.5mg (Addl. 20 Same as approved 06/02/2010 Strength) Ropinirole 6mg ER Tablets (Addl. 21 Same as approved 06/02/2010 Strength) (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 Coseal Surgical Sealent 2/4/8ml 22 formation. 06/02/2010 (Addl. Indication) (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. Pregabalin SR 75/150/300mg + For the treatment of adult patients 23 09/02/2010 Methylcobalamin 1500mcg tablets with peripheral neuropathy For Symptomatic Treatment of chronic stable angina pectoris in coronary artery disease patients Ivabradine Hcl Tablets 5/7.5mg with normal sinus rhythm, indicated 24 10/02/2010 (Additional Indication) in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is >60bpm. Paracetamol Solution for Infusion 25 (10mg/ml) in 50ml (Additional Same as approved 10/02/2010 Packsize) Indicated for the treatment of pain Ketorolac Tromethamine 26 and inflammation following cataract 10/02/2010 Ophthalmic Solution 0.45% surgery. 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 Cytarabine Injection 100mg useful in the treatment of acute 27 10/02/2010 Additional Packsize (20ml) lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of cytarabine is indicated in the prophylaxis and treatment of meningal leukemia. For the relief of the symptoms of Olopatadine Hcl Nasal Spray 0.6% 28 seasonal allergic rhinitis in patients 10/02/2010 w/w (Additional Indication) 6 years of age and older. Sodium chloride 6.80gm + Potassium chloride 0.30 gm + Calcium chloride dihydrate Replacement of extracellular fluid 0.37gm + Magnesium losses in case of isotonic 29 11/02/2010 chloride hexahydrate 0.20gm + dehydration, especially if acidosis is Sodium acetate trihydrate 3.27gm + being imminent or present L-malic acid 0.67gm in 1000ml solution for infusion As an adjunct in abdominal or Chemically Modified Sodium pelvic surgery for reducing the Hyaluronate 30 incidence, extent and severity of 11/02/2010 and Caboxymethylcellulose postoperative adhesions at the site Absorbable Adhesion Barrier. of placement. For the treatment of patients with Lornoxicam 4mg/4mg + 31 acute painful musculoskeletal 12/02/2010 Thiocolchicoside 4mg/8mg tablets conditions For the treatment of adult patients Cefixime 100mg/200mg + with upper & lower respiratory tract 32 12/02/2010 Cloxacillin 500mg/500mg tablets infections, skin and soft tissue infections Celecoxib Mouth Dissolving Tablet For the Treatment of Osteoarthritis 33 25/02/2010 50/100/200 mg and Rheumatoid Arthritis Propofol 2% w/v Injection 34 Same as Approved 27/02/2010 (additionalStrength) For treatment of resistant oedema associated with secondary Spironolactone 25mg + Furosemide 35 hyperaldosteronism; resistant 05/03/2010 20mg tablets hypertension, chronic cardic failure and hepatic cirrhosis Olopatadine5mg + Ambroxol30mg For the management of cough in 36 05/03/2010 tablets adult patients only Methylcobalamin750mcg + Pregabalin75/150mg + Vitamin For the treaetment of painful 37 05/03/2010 B61.5mg + Folic acid0.75mg + diabetic neuropathy in adults only Benfothiamine7.5mg capsules For the management of hyperphosphatemia in adults Calcium acetate 435mg + 38 patients with renal failure being 05/03/2010 Magnesium carbonate 235mg tablets treated with dialysis (hemodialysis or peritoneal dialysis For the treatment of the symptoms Dicyclomine2.5mg + Dried of functional gastrointestinal Aluminimum Hydroxide200mg + disorders like irratible bowel 39 Light Magnesium Oxide100mg + syndrome, functional dyspepsia, 05/03/2010 Simethicone 20mg per 5ml peptic ulcers., GERD which suspension. includes smooth muscle spasm, flatulence, abdominal distension, hyperacdity, gastric distress, bloting etc. For the treatment in adults patients Sertaconazole 2% w/v+ Zinc 40 with dandruff/seborrheic dermatitis 05/03/2010 Pyrithione 1% w/v Shampoo of the scalp For the Treatment of respiratory tract infections, urinary tract Faropenam Sodium Extended 41 infection, skin and skin structure 08/03/2010 Release Tablet 225/300/450 mg infections and gynaecological infections Amlodipine5mg + For the treatment of hypertension 42 Ramipril10mg/5mg Tablets 10/03/2010 only (additional strength) For the treatment of Bronchial 43 Doxofylline MR Tablet 650 mg 11/03/2010 Asthma and COPD in Adults Lidocaine7.5mg + Prilocaine2.5mg For the treatment of adult male 44 12/03/2010 per acutation spray patients with premature ejaculation For the treatment of the sign and Pramipexole Di HCl monohydrate 45 symptoms of idiopathic parkinsons 13/03/2010 ER Tablet 0.375/0.75/1.5/3/4.5 mg disease For the treatment of symptoms of Drosperinone 3mg + Ethinyl premenstrual dysphoric disorders 46 16/03/2010 Estradiol0.02mg tablets (PMDD) in women (additional indication) Miglitol 25 mg + Metformin 500mg 47 Additional Strength 16/03/2010 tablets Propranolol 40mg (SR Pellets) + 48 For the prophylaxis of migraine 16/03/2010 Fluarizine 5mg/10mg capsules Citicholine 500mg + Piracetam 49 For the treatment of acute stroke 16/03/2010 400mg Tablets For the treatment of acute Diclofenac 50mg + 50 inflammation conditions associated 16/03/2010 Chlorzoxazone500mg Tablets with spasm in adults only Mecobalamin 750 mcg + Pyridoxine For the treatment of diabetic 51 1.5mg + Nicotinamide 45 mg + 16/03/2010 neuropathy in adults Benfotiamine 150mg Tablets For the topical treatment of acute 52 Etoricoxib 1%+ Menthol 5% Spray 16/03/2010 musculoskeletal pain For the treatment of patients Pantoprazole 40mg + Cinitapride suffering from non-ulcer dyspepsia 53 17/03/2010 (ER) 3mg Capsules
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