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New Drugs Approved by Drugs Controller NEW DRUGS APPROVED BY DRUGS CONTROLLER NEW DRUGS APPROVED BY DRUGS CONTROLLER (I) DURING THE PERIOD JANUARY 1988 TO AUGUST 2004 (Rearranged in Alphabetical Order) Date of Name of Drug Indications Approval 5-Aminosalicyclic Acid Ulcerative colitis June-1989 Abacavir Anti-HIV 22.03.2002 Abciximab Adjunct to PTCA 02.05.1997 Acamprosate Calcium For Alcohol dependency 30.10.2002 Aceclofenac NSAID 15-09-2003 Aceclofenac (100 mg) + Paracetamol(500 For acute painful condition in adults 29-06-2004 mg) Aclarubicin Injection Anti-Cancer March-1988 Adenosine Anti-epileptic July-1997 Adefovir Dipivoxil Anti-Viral (Hepatitis-B) 04-03-2004 Alendronate Sodium For post menopausal osteoporosis September-97 Alfuzosin E.R. Tablets (10 mg) For BPH 14-05-2004 Alprazolam Anxiolytic agent June-1988 Alprostadil Injection For Erectile Dysfunction 09.05.02 Altretamine Anti-cancer March-95 Acute and chronic disease of the respiratory tract associated Ambroxol HCI wiht abnormal bronchial secretions in particular acute attacks 1.12.1995 of chronic bronchitis asthamatic bronchitis, bronchial asthma. Chemoprotective agent against the serious toxicities Amifostine 21.03.1996 associated with intensive regimens of platinum and alkylating Amineptine Anti-depressant January-88 Amiodarone HCI Cardiac April-90 Amitraz Veterinary August-96 Amlodipine Antihypertensive May-93 Amorolfine Anti-Fungal 25-11-2003 Amrinone Lactate Inotropic agent May-88 Amsacrine In. Anti-cancer February-92 Anastrazole Anti cancer 10.02.2003 Anti-Rabies Vaccine (Killed) Vet. Vaccine March-1989 Apraclonidine Opthalmic Solution a-2 Adrenergic Agosit(Ophth) 15.03.02 Aripiprazole Anti schizophrenia 11.06.2003 Arteether Anti-Malarial 14.01.1997 Artemether injection (Finished Promoted for use in severer malaria a second line in 02.08.1996 formulation) chloroquine resistant malaria cases only Artesunate Malaria 02.08.1996 Astemizole Anti-allergic February-88 Atorvastatin Anti-Hyperlipidaemia 17.09.1999 Atorvastatin Anti-lipid 10.09.1999 Azelaic Acid Anti-Acne 8.7.03 Azelastine Hydrochloride Anti-allergic rhinitis July-97 Azithromycin Antibacterial May-94 Aztreonam Anti-Bacterial 01.11.2002 Babies vaccine Inactivated (Vero-Cell) Vaccine November-88 Bacillocid special Disinfectant (surface) May-92 Voluntary muscle spasticity due to cerebrovascular accidents Page 1 NEW DRUGS APPROVED BY DRUGS CONTROLLER Voluntary muscle spasticity due to cerebrovascular accidents Baclofen 29.09.1995 cerebral palsy, meningitis multiple sclerosis, spinal lesions Balsalezide Disodium For ulcerative colitis 12.11.2002 Bambuterol Bronchodilator 13.12.1999 Basiliximab Injection Immuno Suppressant 28.05.1999 Benazepril HCI Anti-hypertensive and congestive heart failure 22.04.1996 Bendrofluazide Diuretic 24.07.2003 Benidipine HCI Hypertension Angina Pectoris 12.08.1996 Benoxinate HCI Ophthalmic November-92 Benzydamine Topical analgesic April-88 Betaxolol HCI Ophthalmic May-92 Bezafibrate Lipid Lowering Agent January-88 Bicalutamide Tablets Anti-Cancer 07.03.02 Bifonazole Anti - fungal November-97 Bimatoprost (Opthalmic Solution) Anti-Glaucoma 08.01.02 Bipheny-acetic acid NSAID 27.04.1998 Bisoprolol fumarate Anti-hypertensive February-92 Botulinum Toxin Type A.I.M. Injection Neurotoxin acting January-94 Brimonidine Tartrate Opthalmic 18.05.1999 Budesonide Anti-asthmatic February-88 Bulaquine Compound Antimalaria 21.12.1999 Bupropion SR Tab 150mg Smoking cessation 10.4.2001 Buspirone Anxiolytic October-90 Butafosfane+Cyanocobalmin Inj. Veterinary 04.03.1998 Butalex Vet. Drug April-91 Butarphenol Tartarate Opoid Analgesic 11.09.2002 Butenafine HCL cream 1% Anti fungal 14.2.2001 Cabergoline For hyperprolactemia 05.09.2002 Cabergoline 1 mg/2 mg/4 mg tablets For Parkinson's disease 07-05-2004 Calcitriol Injection Vit. D3 Biologically Acitive March-94 Calcitriol Soft Gelatin Capsule Metabolic Bone Disease August-93 Calcium Dobesilate For Chronic Venous September-97 Candesartan Anti-Hypertensive 31.08.2000 Capecitabine Anti-Cancer 12.10.2000 Carboplatin Injection Anti-Cancer March-1989 In Management of Hypertension opth. 20% is in ocular Carteolol HCI hypertension chronic open angle glaucoma and some 09.07.1996 secondary Glaucoma. Carvedilol Antihypertensive agent 16.10.1998 Cefaclor Antibiotic April-91 Cefadroxyl Antibiotic February-1989 Cefdinir Anti-bacterial 10.10.2001 Cefdinir Dispersible tablet (125mg) Antibiotic 27-05-2004 Cefepine HCI Anti-Biotic 30.10.2002 Cefetamet Pivoxil Suspension 250 Anti-Biotic 09-08-2004 mg/5ml Cefetemet-piroxil Antibacterial 14.11.2002 Cefixime Antibiotic March-93 Cefoperazone Sodium Inj. IM/IV August-93 Cefpirome Anti - Infective September-97 Cefpodoxime Proxetil For bronchitis September-97 Antibacterial for use in adult and children with mild to Page 2 NEW DRUGS APPROVED BY DRUGS CONTROLLER Cefpodoxime Proxetil moderate infections involving URT & LRT, skin & soft tissue, 14.03.1996 UTI, Sexually Transmitted infections. Cefprozil Antibiotic 10/1/03 Cefprozil Dispersible Tablet (125 mg/ 250 Antibiotic 22-06-2004 mg) Ceftazidime pentahydrate Antibiotic June-88 Ceftibuten (Finished formulation) URTI, LRTI, UTI 19.11.1996 Ceftiofur Sodium & Ceftiofur HCI Antibiotic (For Veterinary Use) 08.10.2002 Ceftizoxime Sod. Sterile Cephalosporin May-90 Ceftriaxone Sodium Antibiotic April-98 Cefuroxime Antibiotic June-88 Cefuroxime Axetil Antibiotic May-90 Celecoxib NSAID 22.02.2000 Centchroman Oral Contraceptive November-90 Centropazine Antidepressant in the treatment of depression only 16.8.1996 Cephacetril Sodium Veterinary Drug May-92 Cerivastatin Lipid Lowering Agent 11.05.2000 Cetirizine Seasonal rhinitis perennial allergic rhinitis pruritus June-93 Chandonium lodide (Non Steriodal Neuromuscular Blocking Agent) March-94 Chelated Amino Acid Trace Mineral Deficiencies Based Minerals July-93 Cilostazol For intermittent claudication. 23-01-2003 Ciprofloxacin Hydrochloride Anti-bacterial Monohydrate May-1989 Cisapride Gastro-intestinal disorders November-92 Citalopram HBR Anti-depressant 03.10.2001 Citicholine Tablet 500 mg & Injection 250 Membrane permeability enhancer 20.08.2004 mg/ml Cladribine Anti-Cancer 9.9.03 Clarithromycin Antibiotic March-95 Clobazam Anti-epileptic 11.11.1997 Clomipramine HCI Anti-depressant February-92 Clonazepam Anti epileptic January-95 Clopidogrel Anti Platlet Aggregation Inhibitor 2.02.2001 Clopidogrel 75 mg tab Anti Platlet Aggregation Inhibitor 2.22.2001 Closantel (Vet.) Veterinary Drug October-94 Clozapine Schizophrenia March-95 Colfosceric Palmitate Respiratory Distress Syndrome December-93 Coligen (Vet.) Veterinary drug June-90 Collagen with Gentamicin implant Anti-infective 06.05.1998 Collagenase May-94 Complex 15 cream Phospholipid 10.01.1997 Creatine Phosphate Coadjuvant for Cardiac Muscles 20.01.1997 Cumophos (Vet.) Veterinary Drug July-93 Cycolsporin oral soln. Immuno-suppressant June-88 Cypermethrin high cis (Vet.) For control of ticks files, lice and mites in cattle, sheeps dogs, 18.9.1996 poultry. Cyproterone Tablet For Prostatic Cancer 10.6.03 Daclizumab Immuno Supressive Agent 13.10.2000 Bovine respiratory disease in beef cattle non lactating diary Danofloxacin mesylate (Vet. Inj.) cattle calves caused by Phaemolytica P.multocida and enteric 28.07.1995 infections caused by E coli/salmonella sp. Decapeptide For Vitiligo 22.10.2001 Desloratidine Anti-Allergic 30.10.2001 Desmopressine Intra nasal solution / Central or neurogenci Diabetes Insipidus bleeding disorders Page 3 NEW DRUGS APPROVED BY DRUGS CONTROLLER Desmopressine Intra nasal solution / Central or neurogenci Diabetes Insipidus, bleeding disorders, August-1989 nasal spray / Inj. Nocturnal enuresis Desogestrel (to be combined with Ethinyl Oral Contraceptive January-1989 cestradiol) Desonide Cortico Steriod 07.03.1997 Dexarazoxane Powder for Injection Cardio Protective Agent 26.02.02 Diazinon (Vet.) Veterinary April 1990 Diacerein For Osteoarthritis 12.03.2004 Diclofenac Transdermal patch 100 mg/50 For Osteoarthritis & soft tissue injury 10.08.2004 Cm2 Didanosine Anti-HIV 15.11.2000 Dinoprostone (PGE2) For induction of labour February-90 Dipivefrin HCI pressure in chronic open For the control of intra ocular 16.05.1996 angle glaucoma Disodium Pamidronate Injection Anti-cancer February-95 Divalproex Sodium E.R. Tablets Anti-Epileptic 24-06-2004 (750mg/1000 mg) Dobutamine Inotropic Agent October-93 Docetaxel Injection In treatment of patients with locally advanced or metastatic 20.06.1996 breast cancer and small cell lungs cancer. Doneprazol HCL 5/10mg tab. For Alzheirmer's dementia 20.3.2001 Dorzolamide Opthalmic 3.10.03 Dovamectin (Vet.) Vet Drug October-97 Doxazosin Mesylate Anti-hypertensive 11.03.1999 DPT-ACT HiB Vaccine Vaccine January-98 Drotrecogin alpha For severe sepsis 23.07.2002 Dutasteride For BPH 16-02-2004 Ebastine Anti-Allergic 28.09.2001 Tissue adhesion, suture support, Haemostasis wound care, Eerioplast (Fitrin adhesive glue) 19.06.1996 sealing of body cavities & subarachroid space only. Efavirenz 50/100/200mg Tab Anti HIV 6.6.2001 Enalapril Maleate All grades of hypertension August-1989 Enrofloxacin Vet-Drug January-94 Eptifibatide Coronary Heart Ailments 30.06.1999 Eptifibatide IV Injection Acute Coronary Syndrome 25.08.1999 Equino Influenza & equine Vaccine March-1989 Rhinopneumonitis Vaccine (Vet.) Erythropoietin (rDNA) Anaemia due to chronic renal failure January-93 Escitalopram Oxalate. Anti depressant 24.01.2003 Esmolol Hydrochloride Cardio selective beta blocker August-94 Esomeprazole Mag Anti-ulcer 04.12.2001 Estradiol TTS 25,50,100 mcg/day Estrogen February-94 Etanercept-Recomb
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