Teva gets final FDA approval for generic Biaxin

Abbott's antibiotic Biaxin has annual sales of $204 million. The two companies are in dispute over the drug.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) announced today that the US Food and Drug Administration had granted final approval for its abbreviated new drug application (ANDA) for Clarithromycin Tablets USP, 250 mg and 500 mg.

Teva said a launch date had not yet been determined.

Teva's Clarithromycin Tablets are the AB-rated generic equivalent of Abbott's antibiotic Biaxin Tablets. According to Teva, the brand product has annual sales of approximately $204 million.

Teva is currently involved in patent litigation with Abbott concerning this product.

Published by Globes [online], Israel business news - www.globes.co.il - on June 1, 2005

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