LIST OF NEW DRUGS APPROVED IN INDIA FROM …

1 LIST OF NEW DRUGS APPROVED IN INDIA FROM 1981 TO of DrugPharmacological action/ IndicationDate of Approval1 Plantago Ovate (Isapgol) Seed Husk (IP) and Effervescent PowderMarch-19812 Clonidine (Bulk)AntihypertensiveMarch-19813 Mesterolone 25mg TabletMarch-19814 Tamoxifen Citrate 10mgCapsuleApril-19815 Ketoprofen50mg Tablets/CapsulesNon steroidal anti-inflammatory agent- Indicated in the treatment rheumatoid arthritis, Osteoarthritis, ankylosing spondylites, drug sulphadoxine should be used only in the manufacture of tablets containing this drug in combination with pyrimethamine for the treatment of cases of malaria which are resistent to Hydrochloride USPI ndicated in the treatment of Hodgkin s Rabies Vaccine (Human diploid cell)

2 Antirabies- For the treatment of SulfateAminoglycoside antibiotic-Indicated in the treatment of the systemic and local April-1981infections of the kidney, genitourinary tract, lower respiratory tract infections, septicemia, soft tissue infections, gastrointestinal tract infections, infections of the CNS peritonitis or Drug- Indicated in the treatment of (Bulk)Neroleptic agent- Indicated in the treatment of acute & chronic schizophrenia, anxiety, depressive, psychosis & hyperkinetic Valproate (Bulk)

3 Antiepileptic drugOctober-198113 Intralipids Intravenous Fat EmulsionOctober-198114 Sodium ValproateAnti-epileptic drug- indicated in the treatment of all forms of indicated in the treatment of gram +ve organism pathogens, stephylococci & streptococci, contrast medium-indicated in lumber thoracic, cervical & total columnar myelography direct ventriculography (Sodium-2-Mercapto-Ethane Sulphonate)Urotoxic agent- for prevention of urotoxic side effects associated with the treatment December-1981of malignant tumours by OitnmentAnti-anginal drug- Indicated in treatment of angina pectoris due to coronary artery inhibitor-Indicated in the treatment of endometriosis, gynaecomastia, fibrocystic mastitis.

4 Prococious puberty and pubertal breast TartrateAntihypertensive agent-Indicated in the treatment of 100mg/200mgCapsuleMarch-198222 Cisplatin 10mg/50mg per vial InjectionAnticancer-Indicated in treatment of metastatic testicular & metastatic ovarian for InjectionThrombolytic agent- Indicated in the treatment of pulmonary embolism and thrombo embolic disorders involving deep Tartrate50mg/100mg TabletMay-198225 Rosoxacin 150mg CapsuleOral anti-gonococcal agent-Indicated in the treatment of gonorrheal urethritisJuly-198226 Metoprolol Tartrate (Bulk)September-198227 Megaldrate 400mg TabletNovember-198228 Fenbendazole (Bulk)

5 January-198329 Measles Mumps & Rubella VaccineFebruary-198330 Ethacridine Lactate-100mg/200mg DrageeJune-198331 Rifampicin syrupJune-198332 Trimethoprim 100mg TabletJune-198333 Disopyramide Phosphate100mg/5ml & 150 SuspensionDecember-198335 Fenfluramine Hydrochloride60mg Sustained Release TabletSeptember-198436 Nifedipine USP 5mg/10mgCapsuleDecember-198437 Septopal Beads and ChainsIndicated for the treatment of bone and soft tissue Maleate & 5mg/ml Ophthalmic SolutionIndicated in the treatment of chronic open angle glaucoma, ocular hypertension, ophthalmic glaucoma, intraocular (as Hcl)

6 15mg/30mg CapsuleHypnotic-indicated in all types of Hcl Nasal DropsNasal decongestant-Acute cold vasomotor rhinitis to facilitate rhinoscopy and to aid drainage of secretions in affectious of the paranasal Tartrate 1mg/ml InjectionAugust-198542 Praziquantel 600mg TabletNeurocysticercosis-in the August-1985treatment of infections brought about by the larvae of pork tapeworm in the Hydrochloride 25mg/50mg per vial InjectionAnti cancer- in the remission of subjectived objective symptoms of encephaloma gastro-intestinal cancer.

7 Lung cancer malignant lumphoma & chronic 1mg/vial InjectionAugust-198546 Centbucridine InjectionFor the purpose of infiltration or regional block anaesthesia and for dental surgery 2mg/ml InjectionAnaesthetic agent- induction of general anaesthesia and for maintenance of short duration anaesthesia for surgical 25mg/15mg TabletAnti histaminic-in the treatment of vestibular disturbances & vertigo Hcl10mg/20mg/30mg TabletAnti depressant- Indicated in the treatment of endogenous reactive depression anxiety, agitation and insomnia where associated with depressive Mononitrate20mg/40mg/10mg TabletCardiac drug- Indicated in the treatment of coronary heart disease prophylaxis of angina pectoris follow up treatment of August-1985myocardial infarction, pulmonary Sulphate 10mg/25mg/50mg/100mg/ml InjectionAminoglycoside antibiotic-Indicated in the treatment of septicaemia including neonatal sepsis and other severe systemic Hcl 150mg TabletAnti ulcer- Indicated in the treatment of duodenal ulcer.

8 Benign gastric ulcer, post operative ulcer, reflux oesophagitis, Zollinger Ellison Cream/OintmentTopical corticosteroid-Indicated in the treatment of conditions responsive to topical corticosteroids , eczema, dermatitis, psoriasis, lichen Hcl 50mg/150mgCapsuleAnti arrhythmic agent-Indicated in the treatment of existing or anticipated ventricular arrhythmias and ectopic beats such as those found after myocardial infarction and in ischaemic heart disease for arrhythmias induced DRUGS and for idiopathic arrhythmic Hcl 250mg/10ml InjectionAnti arrhythmic agent-Indicated in the treatment of existing or anticipated ventricular arrhythmias and August-1985ectopic beats such as those found after myocardial infarction

9 And in ischaemic heart disease for arrhythmias induced DRUGS and for idiopathic arrhythmic TabletsAnti cancer- In the treatment of metastatic breast 50mg/100mg TabletAnti arrhythmic agent-Indicated in the treatment of hypertension, angina pectoris, cardiac 10mg/40mg per ml InjectionAntibiotic- Indicated in the treatment of serious bacterial infections such as septicaemia, lower respiratory tract infections, serious central nervous system infections, intra-abdominalinfections, complicated & recurrent urinary tract infections, skin & bone Sodium 100gm/200gm per kg Premix (For Veterinary)

10 Coccidiosis- In the treatment of coccidiosis in chicken and Sodium250mg/500mg/1g per vial InjectionCephalosporin antibiotic-Indicated in the treatment of serious infections due to susceptible organisms-respiratory tract infections, urinary tract infections, skin billiary tract infections, Sodium USP25mg/50mg TabletAnti inflammatory agent-Indicated in the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout, painful post operative, pain following dental surgery 40mg/80mg TabletAnti hypertensive agent-Indicated in the treatment of angina pectoris, cardiac arrhythmias and essential Undecanoate40mg CapsuleOral androgen- Indicated for replacement therapy in cases of hypergonadism and male climacteric in the treatment of 4gm/6gm SachetUlcer & burn- In cleansing secreting wounds like venous stasis ulcers, decubitus ulcers, infected traumatic ulcers & infected (as the hydrogen fumerate)