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Generic Drugs

U.S. FDA grants approval for generic equivalent of antibiotic Zithromax tablets

Published in Health and Medicine Week, December 19th, 2005

Teva Pharmaceutical Industries Ltd. (TEVA) announced that the U.S. Food & Drug Administration (FDA) has granted final approval for the company's abbreviated new drug applications (ANDAs) for Azithromycin tablets, 250 mg, 500 mg and 600 mg.

Teva's Azithromycin tablets are the AB-rated generic equivalent of Pfizer's antibiotic Zithromax tablets, which has annual sales of approximately $1.6 billion.

Teva is currently in patent litigation concerning this product in the U.S. District Court for the Southern District of New York.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is pharmaceutical company that develops,...

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