Teva wins FDA approval for generic Gemzar

Eli Lilly has sued Teva for patent violation concerning this drug.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) today won US Food and Drug Administration (FDA) tentative approval for its abbreviated new drug application (ANDA) to market its generic version of Eli Lilly and Co's (NYSE:LLY) cancer treatment Gemzar (Gemcitabine) for injection, 200 mg base/vial.

Teva said that it was currently in patent litigation concerning this product in the US District Court for the Southern District of Indiana. Final FDA approval is expected if the court rules in Teva’s favor or when the of the mandatory stay of approval expires in July 2008, whichever comes first.

Published by Globes [online], Israel business news - www.globes.co.il - on May 8, 2007

© Copyright of Globes Publisher Itonut (1983) Ltd. 2007

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