FDA approves Watson's ANDA for Next Choice ONE DOSE emergency contraceptive

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Jul 13 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 (FDA) for its Abbreviated New Drug Application (ANDA) for Next Choice™ ONE DOSE (Levonorgestrel Tablet, 1.5 mg), the generic equivalent to Teva Women's Health's Plan B One-Step®. Watson plans to launch the product immediately.

For the twelve months ending May 31, 2012, Plan B One-Step® had total U.S. sales of approximately $88 million according to IMS Health data. Plan B One-Step® is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure.

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Watson Pharmaceuticals, Inc.

Posted in: Women's Health News | Pharmaceutical News

Tags: Contraceptive, Food, Levonorgestrel, Medicaid, Medicare, New Drug Application, Pharmaceuticals, Pregnancy, Progestin, Urology

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