FDA approves Teva's version of Abbott antibiotic Biaxin

Abbott is suing Teva for patent infringement over this drug as well as over fenofibrate.

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

Teva's Clarithromycin Extended Release Tablets are the AB-rated generic equivalent of Abbott's macrolide antibiotic Biaxin XL Filmtabs. Biaxin is an antibiotic chemically related to erythromycin. It is used to treat certain bacterial infections of the respiratory tract.

According to Teva, the brand product has annual sales of approximately $284 million.

Teva is currently involved in patent litigation with Abbott concerning this product. Abbott has requested a court hearing for today in connection with its motion for a temporary restraining order. Teva is also involved in a legal dispute with Abbott over fenofibrate, its generic version of Abbott's excess blood cholesterol treatment Tricor.

Published by Globes [online], Israel business news - www.globes.co.il - on May 19, 2005

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