Watson Laboratories receives FDA approval for Zarah tablets

Watson Pharmaceuticals, Inc. (NYSE: WPI), today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Zarah™ (drospirenone and ethinyl estradiol tablets) 3 mg/0.03 mg, the generic equivalent to Bayer's Yasmin®. Watson has begun shipping the product.  Bayer's lawsuit against Watson alleging that Watson's product infringes Bayer's U.S. Patent No. 5,569,652 remains pending in the U.S. District Court for the Southern District of New York.

Yasmin® and its generic equivalents had total U.S. sales of approximately $97 million for the twelve months ending June 30, 2010, according to IMS Health.  Watson's Zarah™ tablets are indicated for the prevention of pregnancy in women who elect to use an oral contraceptive.