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List of Approved Drug from 01.01.08 to 31.12.08

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List of Approved Drug from 01.01.08 to 31.12.08 LIST OF APPROVED DRUG FROM 01.01.08 TO 31.12.08 S. Approval Drug Name Indication No. Date For temporary relief from Me-salicylate 30% + Menthol 10% + camphor 4% pain, swelling & 1 29.11.07 Cream inflammation due to musculoskeletal disorder For improvement of parantial hyperphemia in diabetis mellitus only. When diet and/or exercise or oral, hypoglyceamic 2 Voglibose 0.2mg/0.3mg tablet (Mouth dissolving) 28.12.07 drug or insulin preparation in addition to diet and or exercise do not result in adequate glycemic control. Hydroxychloroquine 400mg tablets (Additional 3 Same as Approved 31.01.08 Strength) ISMN 30mg SR + Metoprolol Succinate equivalent 4 to metoprolol tartrate 25mg/50mg tablets Same as Approved 02.01.08 (Additional Strength) For the treatment of steroid responsive fungal 5 Halobetasol 0.05% + Clotrimazole 1.0% cream 04.01.08 infections including eczema and psoriasis For the treatment of disturbance of consciousness resulting 6 Citicholine Syrup 750mg/5ml from head injuries, brain 04.01.08 operation and acute stage of cerebral infarction in adults only 7 Levodopa 200mg + Carbidopa 50mg C.R. tablet For Parkinson's Disease 08.01.08 For the treatment of burns 8 Nanocrystalline Silver Gel 0.002% 04.01.08 and wound infections For the treatment of 9 Cinitapride (as hydrogen tartrate) 1mg tablet 04.01.08 gastroesophageal reflux disease and functional inconveniences of the gastrointestinal motility For the treatment of adult Tenofovir disoproxil fumarate 300mg + 10 patients with HIV 07.01.08 Lamivudine 300mg tablet infection For the treatment of Urinary tract infections, respiratory tract Cefixime 200mg/100mg + Lactic acid bacillus 2.5 11 infections, biliary tract 07.01.08 billion spores tablet & dispersible tablet infections in adult patients prone to antibiotic associated diarrhoea D-Trans Fentanyl Metrix system (12mcg/hr.) 12 Same as Approved 07.01.08 (Additional Strength) For the treatment of lower Ceftazidime 500mg + Tobramycin 60mg per vial respiratory tract infection 13 08.01.08 (Injection) caused by pseudomonas aeruginosa 14 Atazanavir 300mg capsules (Additional strength) Same as approved 08.01.08 For the prophylaxis of Ertapenem for injection 1gm/vial (additional surgical site infections 15 15.01.08 indication) following elective colorectal surgery As an adjunct to diet and exercise to improve 16 Vildagliptin Tablets 50mg/100mg glycemic control in 18.01.08 patients with type-II diabetes mellitus For the treatment of dyslipidemia associated with atherosclerotic 17 Atorvastatin 10mg + Aspirin 75/150mg Capsules arterial disease with risk 18.01.08 of myocardial infarction, stroke or peripheral vascular disease Smatriptan (as succinate ) 50mg + Naproxen For the treatment of acute 18 22.01.08 sodium 550mg tablets migraine Sodium Valproate 666mg + valproic acid 290mg 19 equivalent as sodium valproate 1000mg C.R. tablet Same as Approved 24.01.08 (Additional Strength) For serious CRTI, uncomplicated and complicated UTI, Cefepime (as hydrochloride) 2000/1000/500mg + Uncomplicated skin & 20 Sulbactam (as sodium) 1000/500/250mg per vial of 24.01.08 skin structure, infection injection acute exacerbation of chronic bronchitis & intraabdominal infection. Ovarian cancer, non-small Paclitaxel Nanoparticle Solution for Injection 21 cell lung cancer and AIDS 22.01.08 20mg/ml (Additional indication) related Kaposis Sarcoma For hepatocellular 22 Sorafenib tablets 200mg (Additional Indication) 22.01.08 Carcenoma For prophylaxes and treatment of both Zanamavir inhalation powder 5mg/blister 23 influenza A & B in adults 22.01.08 (Additional Indication) and children (greater than or equal to 5 years) For the prophylaxis of acute organ rejection in Mycophenolate Mofetil Capsule 250mg, 500mg & 24 patients receiving 23.01.08 Oral suspension 200mg/ml (Additional Indication) allogeneic hepatic transplantation Combikit 4 tablets of Alendronate sodium trihydrate equivalent to Alendronic acid 70mg each For the treatment of 25 + 24 tablets of Calcium carbonate 1250mg osteoporosis in post- 23.01.08 (equivalent to 500mg Calcium) + cholecalciferol- menopausal women 250IU For short term treatment of pain due to post 26 Aceclofenac injection 150mg/ml 23.01.08 operative and post traumatic cases For the treatment of Atorvastatin 10mg + Fenofibrate 80mg tablet 27 combined hyperlipidemia 25.01.08 (Additional Indication) in patients with normal hepatic and renal functions. Sodium Valproate 499.5mg + Valproic acid 28 217.5mg equivalent as sodium valproate- 750mg Same as Approved 24.01.08 CR tablet (Additional Strength) Diclofenac 50mg + Serratiopeptidase 10mg enteric For the treatment of acute 29 24.01.08 coated tablet pain in adults Gabapentin 100mg + methylcobalamin 500mcg 30 Same as Approved 24.01.08 tablets (Additional Strength) For the treatment of infection caused by Cefpirome (as sulphate) 500/1000mg/2000mg + sensitive organisms viz. 31 Sulbactam (as sodium ) 250mg/500mg/1000mg 24.01.08 lower RTI, complicated powder for injection UTI, Septicemia, bacteremia For the treatment of Type- Metformin HCl ER 500mg + Fenofibrate 32 II diabetes associated with 25.01.08 80mg/160mg tablet mixed dyslipidemia Salicylic acid 10mg/20mg (Foaming facewash For the treatment of acne 33 28.01.08 solution) vulgaris For the treatment of 34 Ozagrel Hcl. Tablets 100mg/200mg 28.01.08 bronchial asthma For the treatment of patients with mild to Rivastigmine transdermal patch (each patch of 5m2, moderately severe 35 10m2,15m2 & 20m2 contain Rivastigmine base dementia of the Alzheimer 28.01.08 9/18/27/36mg respectively type and dementia associated with Parkinsons disease For the treatment of complicated skin and skin Daptomycin powder for concentrate for solution for structure infections and 36 28.01.08 infusion (350mg/500mg per vial) for staphylococus aureus bloodstream infections (bacteremia) For the relief of persistent Dextromethorphan Orodispersible strip 37 dry irritating cough in 28.01.08 5.5mg/11mg adult patients only Diclofenac sodium 50mg + Dicyclomine HCl 20mg For the treatment of acute 38 28.01.08 per ml of injection colicky pain in adults For decrease of intraocular pressure in patients with open angle glaucoma or Travoprost 40mcg + Timolol (as Maleate) 5mg per ocular hypertension, who 39 28.01.08 ml of eye drops are insufficiently responsive to topical beta blockers or prostaglandin analogues For RTI, SRS of tissue infection, bons & joint Amoxicillin 250mg/125mg + Cloxacillin infection, ENT infection 40 250mg/125mg + Lactic Acid Bacillus 1.7 Billion 30.01.08 in adults prone to spores antibiotic associated diarrhoea For RTI, SRS of tissue infection, bons & joint Amoxicillin 250mg + Lacto- Bacillus 1.7 billion infection, ENT infection 41 31.01.08 Spores in adults prone to antibiotic associated diarrhoea Mecobalamin1500mcg +Alpha Lipoic Acid100mg+Benfothiamine15mg+B63mg+Calcium For Vitamins and Pantothenate25mg+Folic Acid 1.5mg+Zinc 42 Minerals deficiency states 30.01.08 oxide22.5mg+Chromium in adult patients picolinate65mcg+Inositol10mcg+Lutein5mg capsule Methylcobalamine 750mcg + Alphalipoic acid For Vitamins and 100mg + Benfothiamine 7.5mg + B6 1.5mg + 43 Minerals deficiency states 30.01.08 Calcium pantothenate25mg + Nicotinamide 50mg + in adult patients Folic acid0.75mg capsule Mecobalamin500mcg + Alpha Lipoic Acid200mg + For Vitamins deficiency 44 Benfotiamin 10mg + Pyridoxine3mg + Biotin5mg + 30.01.08 states in adult patients Folic acid 1.5mg capsule For the treatment of lower RTI, skin & soft tissue Amoxycillin 250mg + Cloxacillin 250mg + bone & joint infections, 45 30.01.08 Lactobacillus 2 billion spores capsules ENT infections in adult patients prone to antibiotic associated diarrhoea As 3rd line treatment of sever cases of COPD Tiotropium (as Tiotropium Bromide Monohydrate) when monotherapy and 46 18mcg + Formoterol Fumarate Dihydro. 12mcg + 31.01.08 second line therapy with Ciclesomide 400mcg per capsules two drugs do not respond adequately For the treatment of Metoprolol Succinate Equivalent to Metoprolol patient with both essential 47 Tartrate [ER 25/50mg] + Atorvastatin (As calcium ) 28.01.08 hypertension and 10mg tablets hypercholesterolemia Levocetrizine Di HCl Dispersible tablet 5mg/10mg For allergic rhinitis & 48 28.01.08 (New Dosage form) chronic urticaria Oseltamivir 30mg & 45mg Capsules (Additional 49 Same as Approved 28.01.08 Strength) Treatment of acute Fondaparinax Sodium injection (Additional coronary syndrome (ACS) 50 28.01.08 Indication) with and without ST- segment elevation For remission of acute symptoms of chronic 51 Camostat Mesylate tablets 100mg pancreatitis and post- 29.01.08 operative reflux esophagitis For intradermal Hyaluronic Acid Salt 25mg + Cross-Linked 52 implantation and facial 30.01.08 Hyaluronic acid 25mg per ml in prefilledsyringe soft tissue agumentation For the treatment of 53 Ursodeoxycholic acid tablets 600mg patients with chronic 30.01.08 cholestatic liver disease For the extended treatment of symptomatic venous thromboembolism (VTE) proximal deep 54 Dalteparin Sodium Injection(Additional Indication) thrombosis (DVT) and/or 30.01.08 pulmonary embolism (PE), to reduce the recurrence of VTE in patients with cancer For the topical treatment Beclomethasone Dipropionate 0.25mg + Econazole 55 of bacterial and fungal 30.01.08 10mg + Neomycin 5mg per gm of Cream infections For adjunctive therapy to improve glycemic control in patients with type-II diabetes mellitus, who Exenatide injection (Each 2ml vial contains- have not achieved 56 Exenatide 5mcg/10mcg per 0.2ml ) (Additional 30.01.08 adequate glycemic control Strength)
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