Pharma

Watson gets FDA approval for generic version of Bayer oral contraceptive

Watson Pharmaceuticals‘ (NYSE:WPI) subsidiary Watson Laboratories has received approval form the U.S. Food and Drug Administration for its generic version of Bayer‘s Yaz oral contraceptive. Vestura is also approved to treat mild acne for women ages 14 years or older, but only if it is also being used as an oral contraceptive, according to the […]

Watson Pharmaceuticals‘ (NYSE:WPI) subsidiary Watson Laboratories has received approval form the U.S. Food and Drug Administration for its generic version of Bayer‘s Yaz oral contraceptive.

Vestura is also approved to treat mild acne for women ages 14 years or older, but only if it is also being used as an oral contraceptive, according to the press statement.

Bayer, which has U.S. offices in Pittsburgh, Pennsylvania, is engaged in legal action over the drug with the Parsippany, New Jersey pharmaceutical company.

In April 2008, Bayer sued Watson in the U.S. District Court for the Southern District of New York, alleging that sales of the company’s generic version of Bayer’s Yaz tablets infringes its patent, according to documents filed with the U.S. Securities and Exchange Commission. The complaint sought damages and injunctive relief. In September last year, the court dismissed the case with prejudice. Although final judgment was entered in January this year, Bayer filed a Notice of Appeal with the 2nd U.S. Circuit Court of Appeals. According to the SEC documents, if Watson loses the case, it “could have a material adverse effect on its business, results of operations, financial condition and cash flows.”

Yasmin had total U.S. sales of $173 million for the 12 months ending Sept. 30, 2011, according to IMS Health.

 

 

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