Generic Drugs

Pharmaceutical company receives tentative approval to manufacture new generics

Published in Medical Letter on the CDC and FDA, November 2nd, 2003

Ranbaxy Pharmaceuticals, Inc., (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced that RLL has received tentative approval from the Office of Generic Drugs of the U.S. Food and Drug Administration to manufacture and market Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg and Pravastatin Sodium Tablets, 10 mg, 20 mg, 40 mg, and 80 mg.

Simvastatin tablets (Zocor) are indicated for patients with coronary heart disease and hypercholesterolemia to reduce the risk of total mortality by reducing coronary death; reduce the risk of non-fatal myocardial infarction; reduce the risk for undergoing myocardial revascularization procedures;...

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Source: Medical Letter on the CDC and FDA (2003-11-02)

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