New drugs approved by drugs con

NEW DRUGS APPROVED BY DRUGS CONTROLLER (I) DURING THE PERIOD JANUARY 1988 TO
AUGUST 2004
(Rearranged in Alphabetical Order)
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
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)
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.
Amifostine
Chemoprotective agent against the serious toxicities
21.03.1996
associated with intensive regimens of platinum and alkylating
Amineptine
Anti-depressant
January-88
Amiodarone HCI
April-90
Veterinary
August-96
Amlodipine
Antihypertensive
Amorolfine
Anti-Fungal
25-11-2003
Amrinone Lactate
Inotropic agent
Amsacrine In.
Anti-cancer
February-92
Anastrazole
Anti cancer
10.02.2003
Anti-Rabies Vaccine (Killed) Vet.
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
02.08.1996
Astemizole
Anti-allergic
February-88
Atorvastatin
Anti-Hyperlipidaemia
17.09.1999
Atorvastatin
Anti-lipid
10.09.1999
Azelaic Acid
Anti-Acne
Azelastine Hydrochloride
Anti-allergic rhinitis
Azithromycin
Antibacterial
Aztreonam
Anti-Bacterial
01.11.2002
Babies vaccine Inactivated (Vero-Cell)
November-88
Bacillocid special
Disinfectant (surface)
Voluntary muscle spasticity due to cerebrovascular accidents
Baclofen
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
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
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
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
Cefpodoxime Proxetil
moderate infections involving URT & LRT, skin & soft tissue,
14.03.1996
UTI, Sexually Transmitted infections.
Cefprozil
Antibiotic
Cefprozil Dispersible Tablet (125 mg/ 250 Antibiotic
22-06-2004
mg)
Ceftazidime pentahydrate
Antibiotic
Ceftibuten (Finished formulation)
URTI, LRTI, UTI
19.11.1996
Ceftiofur Sodium & Ceftiofur HCI
Antibiotic (For Veterinary Use)
08.10.2002
Ceftizoxime Sod. Sterile
Cephalosporin
Ceftriaxone Sodium
Antibiotic
April-98
Cefuroxime
Antibiotic
Cefuroxime Axetil
Antibiotic
Celecoxib
22.02.2000
Centchroman
Oral Contraceptive
November-90
Centropazine
Antidepressant in the treatment of depression only
16.8.1996
Cephacetril Sodium
Veterinary Drug
Cerivastatin
Lipid Lowering Agent
11.05.2000
Cetirizine
Seasonal rhinitis perennial allergic rhinitis pruritus
Chandonium lodide
(Non Steriodal Neuromuscular Blocking Agent)
March-94
Chelated Amino Acid
Trace Mineral Deficiencies Based Minerals
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
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
Collagen with Gentamicin implant
Anti-infective
06.05.1998
Collagenase
Complex 15 cream
Phospholipid
10.01.1997
Creatine Phosphate
Coadjuvant for Cardiac Muscles
20.01.1997
Cumophos (Vet.)
Veterinary Drug
Cycolsporin oral soln.
Immuno-suppressant
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
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
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
Dovamectin (Vet.)
October-97
Doxazosin Mesylate
Anti-hypertensive
11.03.1999
DPT-ACT HiB Vaccine
January-98
Drotrecogin alpha
For severe sepsis
23.07.2002
Dutasteride
16-02-2004
Ebastine
Anti-Allergic
28.09.2001
Eerioplast (Fitrin adhesive glue)
Tissue adhesion, suture support, Haemostasis wound care,
19.06.1996
sealing of body cavities & subarachroid space only.
Efavirenz 50/100/200mg Tab
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
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
Anti-Rheumatic
07.12.2001
Ethamsylate
Anti-haemostatic
Etidronate Disodium
Anti-Cancer
March-95
Etodolac
10.04.1997
Etoposide Capsules & Injection
Anti-Cancer
January-88
Etoricoxib
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
March-1989
FDC of Atorvastatin (10 mg/20 mg) +
For Hypercholesterolemia
13-08-2004
Ezetimibe (10 mg) Tablet
FDC of Buprenorphin 2 mg + Naloxone
For Opiod Dependency
19-08-2004
(0.5 mg)
FDC of Esomeprazole 20 mg/40 mg +
29-06-2004.
Domperidone 30 mg SR Capsule
FDC of Gatifloxacin 0.3% +
Dexamethasone Phos. 0.1% w/w Eye
For post-operative inflammatory and bacterial infection of
15-06-2004
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) + Mosapride 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
Fenofibrate
Anti Hyperlipidaemia
22.12.1999
Fenoverine
Anti-spasmodic
Fexofenadine HCI
Antihistamine agent
16.09.1998
Filgrastim Injection
Anti-Cancer
September-93
Finasteride
Begin prostatic hypertrophy
09.10.1996
Firarubicin HCI Inj.
Anti Cancer
Flavophospholipol (Flavomycin)
September-
Antibiotic (Vet.)
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.)
October-97
Flunarizine HCI
Antimigraine
November-90
Flunisolide
Allergic Rhinitis
November-93
Fluoxetine HCI
Anti-depressant
March-90
Flurometholone with Neomycin
In non inflammatory ocular condition
20.07.1996
Fluticasone Propionate
Inflammatory & Pruritic manifestation of cortisteroid
18.03.1996
responsive eczema dermatitis.
Fluvastatin Sodium
Lipid Lowering Agent
25-11-2003
Fluvoxamine Maleate
Anti Depressant
21.02.2000
Fondaparinax Sodium
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
Fotemustine IV injection (finished
In the treatment of disseminated malignant melanoma
formulation)
including cerebral localization and primary malignant cerebral 23.12.1996
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
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
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
Granisetron
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
05.02.1996
Horse Antihuman Lymphocyte Globulin
For Aplastic anaemia
Ibandronic Acid Inj ( 1 mg/ml)
For Anti-Cancer
18-05-2004
Ibopamine HCl
Opthalmic
Idarubicin Hydrochloride
Anti Cancer Drug
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
Vaccine)
Indinavir Sulphate 200mg/400mg
1.2.2001
Influenza vaccine inactivated (finished
Prophylaxis against influenza
30.08.19996
formulation)
Interferon Alpha Inj. (Recombinant)
Anti-cancer
Iobitridol
Contrast-Media
17.10.2001
Iomeprol
Contrast Medium
05.10.2000
Iopromide (Ultravist)
Contrast-Media
Ioversol Injection
Contrast-Media
Ipratropium bromide
Anti-cholinergic bronchodilator
November-92
Irbesartan
Anti-Hypertensive
26.06.2000
Irinotecan HCI Trihydrate
23.05.1997 to
Anti-Cancer
22.05.1999
Isepamicin
Antibiotic
December-97
Isoflurane
Anaesthesia
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
Itrolan (Isovist)
Contrast-Media
October-92
Ketorolac tromethamine
Non-steroidal analgesic anti-inflammatory
April-92
Ketotifen
Anti Asthmatic drug
Korsolex Concentrate
Instrument disinfectant
Lacidipine
06.05.1997 to
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
Lansoprazole
Anti Ulcer
December-94
Latonoprost
Ophthalmic
12.05.1998
L-Camitine
Vitamin Deficiency
Leflunomide
Anti-Rheumatoid Arthritis
01.10.2001
Lercanidine HCL Tablets
Anti-Hypertension
07.05.02
Letrozole
Anti-Cancer
12.03.1998
Levobunolol HCI.
For control of Intra occular pressure in chronic open angle
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
Lofepramine Decanoate
Anti Depressant
January-90
Lomefloxacin
Antibacterial
Loratadine
Long acting anti-histamine
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)
Loxapine
Anti depressant
September-90
Madramicin Concentrate
Veterinary
Mefloquine HCI
Anti Malarial
03.03.1997
Melagenina Lotion
Leukoderma
Melatonin
12.03.1998
Melitracen HCI
Anti-Depressant agent
28.10.1998
Memantine HCl tablet 5 mg/10 mg.
For dementia of Alzheimer's type
19-07-2004
Meloxicam
16.02.1999
Mepartricin
Benign prostatic hyperplasia
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
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
Modafinil
For sleeping disorder
15-12-2003
Mometasone Furoete
Topical Corticosteroid
October-90
Monocomponent Insulin Lispra (rDNA)
Anti-diabetic
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
18.05.1999
Nadifloxacin Cream
Anti-Bacterial (Syn. Quinolone)
28.03.02
Nafarelin Acetate
GnRH Antagonist
17.03.1999
Naloxone Hydrochloride
Barocotic antagonist
Nateglinide Tablets
Anti-Hypertensive
01.05.02
N-butyl-2-cyario Crylate
For treatment of smooth and fresh skin wounds and surgical
06.06.1996
incisions.
Nebivolol HCI
Antihypertensive
12.07.2002
Analgesic
April-91
Nelfenavir Mesylate
02.07.2001
Nelfinavir
29.6.2001
Sweetening Agent
22-04-2004
Nevirapine
06.03.2000
Nicardipine HCI
Anti-Hypertensive
October-93
Nicorandil
Anti Anginal
10.01.1997
Nicotine Transdermal therapeutic System Anti-smoking
Nilutamide
Anti-cancer
October-91
Nimesulide
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
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
Olanzapine
Anti Psychotic
27.01.2000
Omeprazole
Anti-ulcer
April-91
Omidazole
Anti Protozoal
13.01.1997
Ondansetron HCI. Dihydrate
Antiemetic
February-94
Oral Polio Vaccine
Polio Vaccine Oral (Verocell)
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.
01.11.2002
Paroxetine HCI
Anti-Depressant
04.10.2000
Parvastatin
Lipidlowering Agent
20.12.2000
Paspat Injection
Bronchial Asthma Allergic
PCEC Vaccine (Rabies HEP Flurystrain)
November-88
Pefloxacin Mesylate
Anti-bacterial
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
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
Prednicarbate
Anti-skin diseases
August-97
Prenoxdiazine HCI (Libexin)
Anti-Tussive agent
Promegestone
Gynaecological conditions characterised by luteal insufficiency,
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
Purified Vicapsular Polysaccharid of
Typhoid Vaccine
February-93
Salmonella Typhi
Pygenum Africum
30.07.2002
Quetiapine Fumerate
Anti-Psychotic
31.05.02
Quinapril
Anti-Hypertnsive
19.09.2002
Rabbit Anti-human Thymocyte
For Aplastic anaemia
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
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
Risperidone
Anti Psychotic
03.04.1997
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
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
Roxithromycin
Anti-bacterial
March-92
S(-)Amlodipine Besylate
Anti-hypertensive
16.08.2002
Sacchoromyces Boulardi
Irritable bowel syndrome
18.12.1997
Sacchoromyces Boulardi
December-97
Salinomycin (Vet.)
Veterinary drug
December-88
Salmetrol Xinofate
Bronchodilator
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
Secnidazole
Amoebiasis giardiasis bacterial and trichemonal, vaginitis
Selegiline HCI
Anti-Parkinsonism
August 191
Semduramycin Sod.
Veterinary
04.03.1998
Serenda Repcus
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
Sibutramine HCI
Anti-obesity
23.12.1999
Sildenafil tab 25/50/100mg
Men Erectile dysfuction
08.01.2001
Silymarin
Heptoprotective
Simuvastatin
Anti hyperchlokesterolemia
Sirolimus
Immunosuppressant
15.07.2002
Sodium Enoxaparin
Thromboembolic
Sodium Hyaluronate soln.
Aid Intraocular Surgery
Jun-1989
Sodium Picosulphate
Laxatives
11.02.1997
Somatostatin I.V. Infusion
Antihaemorrage
Somatropine (rDNA) Inj.
Growth hormone
04.02.1998
Sorbister Capsules
Nephrological
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
Sterillium rubin disinfectant
Disinfectant for hands
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
Sulpha Chloropyrazine Sodicum
Veterinary
Sulpiride
Anti Depressant
26.10.1999
Sultamicilline
Antimicrobial agent
Sumatriptan Tabs/Injection
Acute migrane attacks with or without aura only when there is
06.02.1996
a clear diagnosis.
Tacrine HCL
For treatment of dementia in patients with alzheimers disease
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
Tadalafil
For Erectile Dysfunction
Tamsulosin HCL Tablets
a-Adrenoceptar Antagonist (For BPH)
04.04.02
Taurolidine 2% or 0.5%
Antimicrobial
Tazarotene
Anti-Acne
12.09.2003
Tegaserod 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
Teratolol Hydrochloride
Anti-hypertensive agenet
Terazosin/HCL
Anti-hypertensive
Terconazole
Anti fungal
Terfenadine
Anti histamine
Teriparatide
For Osteoporosis
Terloipressin Acetate Inj. I.V. (Finished
For the treatment of bleeding Oesophagal varices
22.07.1995
formulation)
Tetra Chlorodecaoxide
Immunomodulator
Tetrabenazine
Presynaptic monoamine Depleting agent.
10.03.1999
Thalidomide
For Leprosy
12.08.2002
As an adjuvant treatment in painful spasm associated with
Thiocolchicoside
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
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
Tolfenamic Acid
04.03.1998
Toltrazuril
Veterinary
30.04.1998
Topiramate
Antiepileptic
23.08.1999
Topiramate Tablet
Epilepsy
23.08.1999
Topotecan HCL
Anti-Cancer (Ovarian)
15.06.1999
Torsamide
Diuretic
09.06.2003
Tramadol
Analgesic
Trandolapril
Anti-Hypertensive
Tranexamic Acid Tabs/Injection
Anti-Fibrinolytic
06.03.02
Trapidil
Adjucnt in angioplasty
11.05.2000
Trastuzumab
Anti-Cancer
10.07.2000
Trflusa 30 mg cap.
Prevention of Thromboembotism
17.01.2001
Triclabendazole (Vet.)
Broad spectrum flukicide
Tripotassium Dicitrato Bismuthate
Anti-ulcer
Jan-1989
Triptorelin (Inj.)
Anti-Cancer
Trolamine Cream (0.67%)
For Topical use
20-03-2004
Tromantadine Hydrochloride
Anti-viral
Valacyclovir
Anti-viral
25.09.2002
Valdecoxib
01.08.2002
Valgancyclovir
20-11-2003
Valsartan
Anti-Hypertensive
10.12.2001
Vancomycin HCL. Inj.
Antibacterial
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
Zafirlukast
Anti-Asthamatic
03.12.2001
Zalcitabine
Anti-Aids
Zidovudine Caps.
Treatment of HIV Infections
Ziprasidone HCL
For Schizophrenia
18.03.2002
Zolendronic Acid
For Hypercalcaemia
05.11.2001
Zolpidem
Insomnia
28.05.1999
Zopiclone
Short-term treatment insomnia
16.08.1996
Zuclopenthioxol Acetate
Schizophrenia
20.08.1999
Zuclopenthixole Acetate
Anti Maniac and Anti-Schizophrenia
29.07.1999

Source: http://pharmabiz.com/services/pharmalawsdocs/docs/dcgi_newdrugs_2004.pdf