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Watson's generic Lybrel receives US FDA approval

Parsippany, New JerseyThursday, June 9, 2011, 14:00 Hrs  [IST]

Watson Pharmaceuticals, Inc. announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for Levonorgestrel and Ethinyl Estradiol tablets, USP, 0.09 mg/0.02 mg, the generic equivalent to Pfizer's Lybrel tablets. Watson expects to launch the product shortly.

Lybrel had total US sales of just under $12 million for the twelve months ending April 30, 2011, according to IMS Health. Lybrel tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

Watson Pharmaceuticals, Inc. is an integrated global specialty pharmaceutical company. The company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on urology and women's health.

 
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