FDA Approves Watson’s Generic Version of Plan B One-Step
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.
Source: Watson Pharmaceuticals via PR Newswire