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Watson Pharma files FDA application to market generic Yasmin

Apr. 21, 2008 (Thomson Financial delivered by Newstex) --

CORONA, Calif. (AP) - Drug maker Watson Pharmaceuticals Inc. (NYSE:WPI) confirmed Monday it has filed an abbreviated new drug application with the U.S. Food and Drug Administration for a generic version of oral contraceptive Yasmin.

Watson is seeking approval to market its drospirenone and ethinyl estradiol tablets prior to the expiration of patents owned by Bayer HealthCare (NYSE:BAY) Pharmaceuticals Inc., the maker of Yasmin.

Bayer filed a lawsuit against Watson on Friday in U.S. District Court of Southern New York seeking to prevent Watson from commercializing its product prior to the expiration of its patents.

Bayer's suit was filed under the provisions of the Hatch Waxman Act, which allows companies 60 days to file for a patent extension. The court has granted a stay of FDA approval for up to 30 months or until final resolution of the lawsuit, whichever occurs first.


Copyright 2008 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.



Newstex ID: AFX-0013-24650692

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