Watson receives US FDA approval for generic equivalent of Bayer's Yasmin
Watson Pharmaceuticals subsidiary, Watson Laboratories, Inc., recently received approval from the US FDA for its ANDA for zarah (drospirenone and ethinyl estradiol tablets) 3 mg/0.03 mg, the generic equivalent to Bayer's Yasmin. Watson's Zarah tablets are indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. The company has already begun shipping the product.
Bayer's lawsuit against Watson alleging that Watson's product infringes Bayer's US Patent No. 5,569,652 remains pending in the US District Court for the Southern District of New York. Yasmin and its generic equivalents had total US sales of approximately $ 97 million for the twelve months ending June 30, 2010, according to IMS Health.
Watson Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialised branded pharmaceutical products focused on urology and women's health.