Watson's Generic Version of Plan B One-Step Receives FDA Approval
PARSIPPANY, N.J., July 13, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. 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, Inc.
Posted: July 2012