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 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 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 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 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 SR Tab 150mg Smoking cessation 10.4.2001 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 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 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 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 Hydrochloride Anti-bacterial Monohydrate May-1989 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 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 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. 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 August-94 Esomeprazole Mag Anti-ulcer 04.12.2001 Estradiol TTS 25,50,100 mcg/day Estrogen February-94 Etanercept-Recomb Anti-Rheumatic 07.12.2001 Ethamsylate Anti-haemostatic May-88 Etidronate Disodium Anti-Cancer March-95 Etodolac NSAID 10.04.1997 Etoposide Capsules & Injection Anti-Cancer January-88 Etoricoxib NSAID 05-03-2004 Exemestane Anti-Cancer 18.10.2001 Ezetimibe Lipid Lowering Agent 18-12-2003 Famiciclovir Tablets Guanine Analogue 11.04.02 Famotidine Anti-ulcer May-1989 Farvoviru Vaccine Vaccine March-1989 FDC of Atorvastatin (10 mg/20 mg) + For Hypercholesterolemia 13-08-2004 Ezetimibe (10 mg) Tablet

Page 4 NEW DRUGS APPROVED BY DRUGS CONTROLLER

FDC of Buprenorphin 2 mg + For Opiod Dependency 19-08-2004 (0.5 mg) FDC of Esomeprazole 20 mg/40 mg + For GERD 29-06-2004. Domperidone 30 mg SR Capsule FDC of Gatifloxacin 0.3% + For post-operative inflammatory and bacterial infection of Dexamethasone Phos. 0.1% w/w Eye 15-06-2004 eyes. drops FDC of Glibenclamide 2.5 mg/ 5 mg + Anti-diabetic 20-08-2004 Metformin SR 500 mg tablet FDC of Lamivudine 300 mg (E.R) + Zidovudine 600 mg (E.R) + Nevirapine 400 Anti-AIDS 15-07-2004 mg tablets FDC of Rabeprazole (20 mg) + For GERD 27-07-2004 S.R. (15 mg) Tablet FDC of Sucralfate 0.07 + metronidazole 0.01 gm + Lignocain 0.04 gm per gram of For bedsore, haemorrhoid fistula and anal fussure 19-08-2004 cream Felodipine Anti-hypertensive May-91 Fenofibrate Anti Hyperlipidaemia 22.12.1999 Fenoverine Anti-spasmodic 8/10/03 Fexofenadine HCI agent 16.09.1998 Filgrastim Injection Anti-Cancer September-93 Finasteride Begin prostatic hypertrophy 09.10.1996 Firarubicin HCI Inj. Anti Cancer May-91

Flavophospholipol (Flavomycin) Antibiotic (Vet.) September- 1989 Flecainide Acetate Aniarrhythmic March-93 Fluconazole Systemic Antifungal January-93 Fluconazole Gel (0.5%) Anti-fungal 12-08-2004 Fludarabine Phosphate Anti-Cancer 26.06.1999 Flumethrin (Vet.) Vet Drug October-97 HCI Antimigraine November-90 Flunisolide Allergic Rhinitis November-93 HCI Anti-depressant March-90 Flurometholone with Neomycin In non inflammatory ocular condition 20.07.1996 Inflammatory & Pruritic manifestation of cortisteroid Fluticasone Propionate 18.03.1996 responsive eczema dermatitis. Fluvastatin Sodium Lipid Lowering Agent 25-11-2003 Fluvoxamine Maleate Anti Depressant 21.02.2000 Fondaparinax Sodium LMWH 22-10-2003 Formestane Depot Inj. Anti-Cancer March-95

Fortison Liquid/Powder Pepti-2000 Liquid Nutritional preparation January-95 Powder Fosinopril Sodium Tabs Anti-Hypertension 10.01.02 Fosphenytoin Sod. Anti-Epileptic 01.10.2002 In the treatment of disseminated malignant melanoma Fotemustine IV injection (finished including cerebral localization and primary malignant cerebral 23.12.1996 formulation) tumours. Fucidic Acid hemihydrate Ophthalmic March-92

Gabapentin (Finished formulation) As adjunctive therapy in the treatment of partial seizures with 03.08.1995 and without secondary generalisation in adults with epilepsy Gadobenate(Dimeglumine IV Injection) MRI Contrast Medium 07.03.2003 Gadodiamide I.V. Injection Contrast Media January-94 Gadopentetic acid Dimeglumine salt Contrast Media May-92 Gadoversetamide Injection MRI Contrast Medium 04.06.2003 Ganciclovir Anti Viral 05.04.2000 Gatifloxacin Anti-bacterial 03.10.2001 Gefitinib Anti-cancer 17-02-2004

Page 5 NEW DRUGS APPROVED BY DRUGS CONTROLLER

Gemcitabine Inj. In management of non small cell lung cancer. 24.01.1996 Gemfibrozil Lipid lowering agent August-88 Gemtuzumab For Myeloid Lukemia 12.09.2002 Genirelix Fertility Drug 08.10.2001 Genotropin Injection Growth Harmone September-94 Ginkgo biloba extract Herbal extract September-92 Gliclazide Anti-diabetic November-88 Glimpiride Anti-diabetic 22.01.1999 Glucomannan Anti-Diabetic (Herbal) September-93 Goserelin Acetate For the treatment of prostate cancer, endometriosis. 24.04.1996 Anti-Emetic 05.07.2000 Haemophilus Type b Congugate Vaccine Influenzae Vaccine December-94 Haloperiodol Chronic Schizophrenia February-90 Haltrexone In treatment of narcotic dependence and alcohol dependence 11.10.1996 Hepatitis - A Vaccine 05.02.1996 Horse Antihuman Lymphocyte Globulin For Aplastic anaemia May-91 Ibandronic Acid Inj ( 1 mg/ml) For Anti-Cancer 18-05-2004 Ibopamine HCl Opthalmic 3/10/03 Idarubicin Hydrochloride Anti Cancer Drug May-91 Idebenone For cerebral arteriosclerosis September-97 Imatinib Mesylate Anti-Cancer 09.12.2001 Imidapril Anti-hypertensive 23-02-2004 Imipenem +Cilastatin Anti-Bacterial 25-07-2003

Immucyst (Bacillus Calmette & Guerin Anti-Cancer June-92 Vaccine) Indinavir Sulphate 200mg/400mg Anti HIV 1.2.2001 Influenza vaccine inactivated (finished Prophylaxis against influenza 30.08.19996 formulation) Interferon Alpha Inj. (Recombinant) Anti-cancer May-88 Iobitridol Contrast-Media 17.10.2001 Iomeprol Contrast Medium 05.10.2000 Iopromide (Ultravist) Contrast-Media July-90 Ioversol Injection Contrast-Media Dec-93 Ipratropium Anti-cholinergic bronchodilator November-92 Irbesartan Anti-Hypertensive 26.06.2000

Irinotecan HCI Trihydrate Anti-Cancer 23.05.1997 to 22.05.1999 Isepamicin Antibiotic December-97 Anaesthesia July-90 Isopropyl Unoprostone Ophthalmic 25-11-2003 Isotretinoin Soft Gel Caps. For Acne Vulgaris 21.06.02 Itopiride Capsules Gastro Prokinetic Agent 09.05.02 Itraconazole Antifungal July-93 Itrolan (Isovist) Contrast-Media October-92 Ketorolac tromethamine Non-steroidal analgesic anti-inflammatory April-92 Anti Asthmatic drug May-91 Korsolex Concentrate Instrument disinfectant May-92 06.05.1997 to Lacidipine Anti-Hypertensive 05.05.1999 Lamivudine Anti - Aids 27.03.1998 Lamotrigine Anti-Epileptic 14.05.1998

Lamotrigine S.R. tablet 50 mg/100 Anti-Epileptic 26-08-2004 mg/200 mg

Page 6 NEW DRUGS APPROVED BY DRUGS CONTROLLER

Lansoprazole Anti Ulcer December-94 Latonoprost Ophthalmic 12.05.1998 L-Camitine Vitamin Deficiency June-90 Leflunomide Anti-Rheumatoid Arthritis 01.10.2001 Lercanidine HCL Tablets Anti-Hypertension 07.05.02 Letrozole Anti-Cancer 12.03.1998 For control of Intra occular pressure in chronic open angle Levobunolol HCI. 16.05.1996 glaucoma and occular hypertension. Levocertizine Anti-histaminic 12.12.2002 Levofloxacin Antibacterial 26.07.1999

Levosalbutamol Tablet 1 mg/2mg & Syrup For Obstructive airway disease 16-07-2004 1 mg/5 ml. Levovist Constrast-Media November-97 Levprolide Acatate Dept. Inj. Anti-Cancer December-97 Linezolid Anti-bacterial 04.10.2001 Linezolid (600 mg) Tablet For Osteomyelitis in adults 30-05-2004 Lisinopril Anti-hypertensive November-91 Lithium Carbonate ER (450mg) tablet Anti Depressant 28-06-2004 Decanoate Anti Depressant January-90 Lomefloxacin Antibacterial May-94 Loratadine Long acting anti-histamine June-92 Losartan Potasssium Anti-hypertensive 16.06.1998 Loteprednol Etabonate Opthalmic Steroidal Anti-Inflammatory Ophth 15.03.02 Solution Reduction of total L.D.L. Choloesterol in patients of primay Lovastatin hypercholesterolemia (type IIa and type IIb 05.10.1995 hyperlipoprolcinemia) Anti depressant September-90 Madramicin Concentrate Veterinary July-93 Mefloquine HCI Anti Malarial 03.03.1997 Melagenina Lotion Leukoderma May-88 Melatonin Hormone 12.03.1998 HCI Anti-Depressant agent 28.10.1998 HCl tablet 5 mg/10 mg. For dementia of Alzheimer's type 19-07-2004 Meloxicam NSAID 16.02.1999 Mepartricin Benign prostatic hyperplasia May-93 Meropenem Injection B-lactum Antibiotic 08.01.02 Metadoxine For Hepatic Disorder 24-10-2003 Metaxalone Muscle Relaxant 08.10.2002 Metolazone Diuretic 23.04.2003 Midazolam Anasthetic General 15.04.1997 Mifepristone Tablets Progesterone Antagonist (For M.T.P.) 13.02.02 Miglitol Tablet 25 mg/50 mg/100 mg Anti-Diabetic 18-08-2004 Milrinone Lactate Injection Congestive Heart Failure 17.05.1999 Miltefosine TAblets For Kalazar 15.03.02 Minocycline Antibiotic May-88 Minoxidil Male-pattern baldness April-88 Misoprostol 200 mcg Anti ulcer 21.06.2001 Mitoxantrone HCI Anti-Cancer March-1989 Mitrazapine 15/30/45mg Tabs Anti-Depressant 14.02.2001 Mizolastine Tablets Anti-Allergic 15.03.02 Moclobemide Anti-Depressant 28.07.2000

Page 7 NEW DRUGS APPROVED BY DRUGS CONTROLLER

Modafinil For sleeping disorder 15-12-2003 Mometasone Furoete Topical Corticosteroid October-90

Monocomponent Insulin Lispra (rDNA) Anti-diabetic Dec-97 Injection Montelucast + Bambuterol Anti Asthma 06.06.2003 Mosapride Prokenetic agents GERD 13.03.2001 Moxidectin (1%) 1M Veterinary 16.01.1997 Moxifloxacin 400mg Tab Anti bacterial 26.06.2001 Mupirocin Anti-bacterial skin infection September-91 Mycophenolate Mofetil Immuno supressive agent 07.02.1999 Nabumetone NSAID 18.05.1999 Nadifloxacin Cream Anti-Bacterial (Syn. Quinolone) 28.03.02 Nafarelin Acetate GnRH Antagonist 17.03.1999 Naloxone Hydrochloride Barocotic antagonist July-92 Nateglinide Tablets Anti-Hypertensive 01.05.02 For treatment of smooth and fresh skin wounds and surgical N-butyl-2-cyario Crylate 06.06.1996 incisions. Nebivolol HCI Antihypertensive 12.07.2002 Analgesic April-91 Nelfenavir Mesylate Anti HIV 02.07.2001 Nelfinavir Anti HIV 29.6.2001 Neotame Sweetening Agent 22-04-2004 Nevirapine Anti HIV 06.03.2000 HCI Anti-Hypertensive October-93 Nicorandil Anti Anginal 10.01.1997 Nicotine Transdermal therapeutic System Anti-smoking May-95 Anti-cancer October-91 Nimesulide NSAID January 1995 Nimesulide Injection 75mg/ml. For short-term treatment of post-operative pain. 28-06-2004 Nimodipine Cerebral Protective agent August-92 Nitazoxanide Anti-Diarrhoeal 17-03-2004 Nitrendipine Anti-hypertensive May-91

Nitroscanate (Vet.) For Control/eradication of hook worms/Round 19.02.1996 worms/Tapeworms in puppies and adult dogs. Octylonium Bromide For Irritable Bowel Syndrome 12.12.2000 Ofloxacin Antibacterial February-90 Anti Psychotic 27.01.2000 Omeprazole Anti-ulcer April-91 Omidazole Anti Protozoal 13.01.1997 HCI. Dihydrate Antiemetic February-94 Oral Polio Vaccine Polio Vaccine Oral (Verocell) May-92 Orthoclone Sterile (OKT3) Immuno-suppressant October-90 Oxaliplatin Inj. Anticancer agent 26.10.1998 Oxcarbazepine Anti-Epileptic 30.10.2001 Oxiconazole Antifungal 17.01.2000 Oxybutynin chloride Antoimuscarinic agent 03.09.1998 Oxybutynine E.R. tablets For Neurogenic bladder disorder 05-05-2004 Paclitaxel Injection Anti Cancer August-94 Pantoprazole tabs Antiulcer agent 09.12.1998 Parecoxib Inj. NSAID 01.11.2002 Paroxetine HCI Anti-Depressant 04.10.2000

Page 8 NEW DRUGS APPROVED BY DRUGS CONTROLLER

Parvastatin Lipidlowering Agent 20.12.2000 Paspat Injection Bronchial Asthma Allergic May-93 PCEC Vaccine (Rabies HEP Flurystrain) Vaccine November-88 Pefloxacin Mesylate Anti-bacterial May-91 Penflundol Neuroleptic agent March-88 Perindopril Anti-hypertensive September-91 Permethrin Antilice/Antiscabies March-95 Pimcrolimus 10 mg/gm cream For atopic dermatitis 23-07-2004 Pioglitazone HCI Anti Diabetic 17.10.2000 Piperacillin sodium Antibiotic August-1989 Piperacillin+Tazobactum IV Inj. Antibiotic 13.08.1999 Piperacillment Tazabactum Respiratory Tract Infections 09.08.1999 Pipercuronium Bromide Non-depolarising muscle relaxing agent November-92 Piribedil Idopathic Parkinsons Disease September-93

Piroxicam Betacylodextrin Rhematoid Arthritis, osteroarthritis, ankylosing spondylitis, 25.03.1996 acute muscio skeletal disorders, acute gout. Podophyllotoxin Anogenital/Nonfacial warts May-95 Polysacharide pneumococcal Vaccine For prevention and pnesonoccocal pneumonia 09.07.1996 (Finished formulation) Polyvinlyl Alcohol with Povidone and For relief from burning irritation and discomfort due to dryness 11.01.1996 chlorbutanol eye drops of the eye. Poractant For respiratory distress in preterm babies 24.12.2002 Prazosin Anti-hypertensive June-90 Prednicarbate Anti-skin diseases August-97 Prenoxdiazine HCI (Libexin) Anti-Tussive agent July-90 Gynaecological conditions characterised by luteal insufficiency, Promegestone 23.09.1996 menstrual irregularities and dysmenorrhea Propfol Inj. Anaesthetic agent 05.05.1998 Propoxur+Flumethrin Veterinary 03.02.1997

Purified chick Embryo Tissue Culture Vaccine (Human use) December- Rabies Vaccine 1989 Purified Vicapsular Polysaccharid of Typhoid Vaccine February-93 Salmonella Typhi Pygenum Africum For BPH 30.07.2002 Fumerate Anti-Psychotic 31.05.02 Quinapril Anti-Hypertnsive 19.09.2002

Rabbit Anti-human Thymocyte For Aplastic anaemia May-91 Immunoglobulin I.V. Rabeprozole Anti-Ulcer 27.12.2001 Rabeprazole Sodium Injection 20 For Gastric and Deudonal Ulcers & GERD 12-05-2004 Racecadotril Anti-Diarrhoeal 10.10.2001 Ramipril ACE inhibitor August-91 Rebamipide 100 mg tablet For gastric ulcer 28-07-2004 Reboxetine Anti-depressant 31.12.2002 Racecadotril Sachet (10 mg/30 mg) Anti-Diarrhoeal 18-05-2004 Recombinant Human Tissue Type Fibrinolytic therapy July-99 plasminogen activator Inj. (Actilyse) Reloxifen HCL 60mg Tab. Menopausal osteoporosis 04.05.2001 Repaglinide Anti Diabetic 23.03.2000 Retrodrine HCI Toxaemia of pregnancy February-95 Ribavirin (Virazole) Antiviral agent November-90 Rilmenidine Dihydrogen Phosphate Anti hypertensive February-95 Riluzole Tablets For motor neurone disease October-97 Risedronate Sodium For Osteoporosis 17-10-2003 Anti Psychotic 03.04.1997

Page 9 NEW DRUGS APPROVED BY DRUGS CONTROLLER

Ritonavir Capsules Anti-HIV September-97 Rituximab Anti-Cancer 10.07.2000 Rivastigmine Caps Acetylcholine esterase inhibitor agent. 31.07.1998 Rizapriptan Anti migrain 27.02.2003 As an adjuvant to general anaesthesia to facilitate endo Rocuromiem Bromide Inj. tracheal intubation to provide skeletal muscle relaxation 18.06.1996 during surgery. Rofecoxib NSAID 26.06.2000 Ropinrole For Parkinson's Disease 03.12.2001 Rosiglitazone Maleate Anti Diabetic 28.06.2000 Rosiglitazone Anti Diabetic 14.07.2000 Rosuvastatin Lipid lowering Agent 12-09-2003 Rowachol For hepato-billary disorders September-91 Roxatidine Acetate HCI Anti-ulcer May-91 Roxithromycin Anti-bacterial March-92 S(-)Amlodipine Besylate Anti-hypertensive 16.08.2002 Sacchoromyces Boulardi Irritable bowel syndrome 18.12.1997 Sacchoromyces Boulardi Yeast December-97 Salinomycin (Vet.) Veterinary drug December-88 Salmetrol Xinofate Bronchodilator Dec-93 Salmon CalCalcitonin Inj. (finished Hypercalceamia pain associated with advanced metastic bone 03.08.1995 formulation) osteoporosis cancer, Pagets disease, post menopausal Saquinavir Capsules Anti-HIV August-97 S-Atenolol Anti-hypertensive 11/9/03 Secnidazole Amoebiasis giardiasis bacterial and trichemonal, vaginitis May-93 Selegiline HCI Anti-Parkinsonism August 191 Semduramycin Sod. Veterinary 04.03.1998 Serenda Repcus For B P H Sep-97 Sertraline HCI. Anti-depressant 09.06.1998

Sevoflurene inhalation (Finished For induction and maintenance of general anesthesia in all 09.07.1996 formulation) types of procedures and patients. Sexfenfluramine HCI Anti-obesity Jun-92 Sibutramine HCI Anti-obesity 23.12.1999 Sildenafil tab 25/50/100mg Men Erectile dysfuction 08.01.2001 Silymarin Heptoprotective Jun-95 Simuvastatin Anti hyperchlokesterolemia Sep-97 Sirolimus Immunosuppressant 15.07.2002 Sodium Enoxaparin Thromboembolic Mar-92 Sodium Hyaluronate soln. Aid Intraocular Surgery Jun-1989 Sodium Picosulphate Laxatives 11.02.1997 Somatostatin I.V. Infusion Antihaemorrage Apr-95 Somatropine (rDNA) Inj. Growth hormone 04.02.1998 Sorbister Capsules Nephrological Sep-93 Community, acquired Pneumonea acute exacerbation of Sparfloxacin chronic bronchitis, other lower gonococcal and non gonococcal 11.11.1996 Burethritis is complicated U.T.I. Spenglersan Immuno-Modulator 02.06.1997 Stavudine Anti-HIV Jul-97 Sterillium rubin disinfectant Disinfectant for hands May-92

Stronger Neo minophagen-C (Finished Indicated for the management of sub-acute hepatic failure 14.12.1995 Formulation) Sufentanil Citrate Anesthetic Agent 17-12-2003 Sulbutiamine Symptomatic treatment of functional asthenia. 22.04.1996

Page 10 NEW DRUGS APPROVED BY DRUGS CONTROLLER

Sulpha Chloropyrazine Sodicum Veterinary Nov-93 Sulpiride Anti Depressant 26.10.1999 Sultamicilline Antimicrobial agent May-94

Sumatriptan Tabs/Injection Acute migrane attacks with or without aura only when there is 06.02.1996 a clear diagnosis. For treatment of dementia in patients with alzheimers disease Tacrine HCL 14.02.1996 of mild to moderate severity. Tacrolimus Capsule(0.5mg/1mg/5 mg) For organ rejection 21-05-2004 Tacrolimus Ointment Immuno-modulator 10/3/03 Tadalafil For Erectile Dysfunction 11/9/03 Tamsulosin HCL Tablets a-Adrenoceptar Antagonist (For BPH) 04.04.02 Taurolidine 2% or 0.5% Antimicrobial Jan-94 Tazarotene Anti-Acne 12.09.2003 Maleate For irritable bowel syndrome 01.11.2002 Teicoplanin for IV/IM Antibiotic 19.02.1997 Telmisartan Anti-hypertensive 25.11.2002 Temozolamide Anti Cancer 17.01.2000 Tenoxicam NSAID Apr-93 Teratolol Hydrochloride Anti-hypertensive agenet Jun-88 Terazosin/HCL Anti-hypertensive Jan-95 Terconazole Anti fungal Jul-94 Terfenadine Anti histamine Sep-90 Teriparatide For Osteoporosis 4/9/03

Terloipressin Acetate Inj. I.V. (Finished For the treatment of bleeding Oesophagal varices 22.07.1995 formulation) Tetra Chlorodecaoxide Immunomodulator Nov-92 Tetrabenazine Presynaptic monoamine Depleting agent. 10.03.1999 Thalidomide For Leprosy 12.08.2002 As an adjuvant treatment in painful spasm associated with degenerative vertebral disorder & vertebral static problems, 25.03.1996 Torticollis dorsal pain, low back pain, Traumatological and neurological disorders Thymogen Injection Anti-Cancer 12.02.02 Thymosin Alfa-I Inj. 1.6mg/vial For Chronic Heptitis-B 17.01.2001 Tiagabine HCl tablet(2/ 4 /12 /16 mg) Anti-Epileptic 14-05-2004 Tiaprost Trometamol Inj. Veterinary 19.02.1997 Ticlopidine Antiplatlet aggregation Feb-93

Tiobolone In treatment of Complaints resulting from natural of surgical 16.10.1996 menopause Tiotropium Bromide Anti asthematic 16.04.2003 Tirofiban HCl I.V Anti-Platelet 12.08.2003 Tizenidine HCL Muscle-Relaxant Dec-93 NSAID 04.03.1998 Toltrazuril Veterinary 30.04.1998 Antiepileptic 23.08.1999 Topiramate Tablet Epilepsy 23.08.1999 Topotecan HCL Anti-Cancer (Ovarian) 15.06.1999 Torsamide Diuretic 09.06.2003 Analgesic Jan-93 Trandolapril Anti-Hypertensive 3/10/03 Tranexamic Acid Tabs/Injection Anti-Fibrinolytic 06.03.02 Trapidil Adjucnt in angioplasty 11.05.2000 Trastuzumab Anti-Cancer 10.07.2000

Page 11 NEW DRUGS APPROVED BY DRUGS CONTROLLER

Trflusa 30 mg cap. Prevention of Thromboembotism 17.01.2001 Triclabendazole (Vet.) Broad spectrum flukicide Sep-88 Tripotassium Dicitrato Bismuthate Anti-ulcer Jan-1989 Triptorelin (Inj.) Anti-Cancer Jul-93 Trolamine Cream (0.67%) For Topical use 20-03-2004 Tromantadine Hydrochloride Anti-viral Feb-95 Valacyclovir Anti-viral 25.09.2002 Valdecoxib NSAID 01.08.2002 Valgancyclovir For CMV 20-11-2003 Valsartan Anti-Hypertensive 10.12.2001 Vancomycin HCL. Inj. Antibacterial Mar-94 Venlafaxine HCI Anti-Depressant 18.09.2000 Vimpocetine Vasolilator 13.05.2002 Vindesine sulphate Injection Anticancer agent 28.10.1998 Vinorelbin Tartrate Inj. Anti Cancer 17.01.2001 Vinpocetin Anti-pychotic 01.08.2003 Xylazine HCL Vet. Drug Nov-90 Zafirlukast Anti-Asthamatic 03.12.2001 Zalcitabine Anti-Aids Jul-93 Zidovudine Caps. Treatment of HIV Infections Apr-88 HCL For Schizophrenia 18.03.2002 Zolendronic Acid For Hypercalcaemia 05.11.2001 Insomnia 28.05.1999 Short-term treatment insomnia 16.08.1996 Zuclopenthioxol Acetate Schizophrenia 20.08.1999 Zuclopenthixole Acetate Anti Maniac and Anti-Schizophrenia 29.07.1999

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