FDA approves Watson's generic BONIVA ANDA to treat osteoporosis in women

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Mar 21 2012

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Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary Watson Laboratories, Inc. has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Ibandronate 150mg tablets, the generic equivalent to Roche's BONIVA® tablets.

Watson intends to begin shipping the product in the second quarter. BONIVA® 150mg tablets had total U.S. sales of approximately $510 million for the twelve months ending January 31, 2012, according to IMS Health. Ibandronate tablets are indicated to prevent and treat osteoporosis in women who have undergone menopause. Roche has sued Watson for patent infringement in connection with Watson's ANDA for Ibandronate 150mg tablets. That lawsuit remains pending.

SOURCE Watson Pharmaceuticals, Inc.

Posted in: Women's Health News | Pharmaceutical News

Tags: Food, Medicaid, Medicare, Menopause, New Drug Application, Osteoporosis, Pharmaceuticals, Urology

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