Anti-Infectives

FDA approves manufacturing and marketing of Cefaclor Tablets, Chewable

Published in Medical Letter on the CDC and FDA, January 25th, 2004

Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced that RLL has received the first approval from the U.S. Food and Drug Administration (FDA) to market the anti-infective Cefaclor Tablets, Chewable in 125 mg, 187 mg, 250 mg and 375 mg.

The Office of Generic Drugs, FDA, has determined the Ranbaxy formulations to be bioequivalent and, has the same therapeutic effect as the reference listed drug Ceclor Liquid, 125 mg, 187 mg, 250 mg and 375 mg, respectively, of Eli Lilly and Company.

RPI will be responsible for marketing this product under the brand name Raniclor in this newly formulated dosage...

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Source: Medical Letter on the CDC and FDA (2004-01-25)

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