Watson Pharmaceuticals Receives FDA Approval for Generic PLAN B(R) for Over-the-Counter Use
MORRISTOWN, N.J., Aug. 28 Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Levonorgestrel Tablets, 0.75 mg for over-the-counter use in women ages 17 and above, as well as for prescription use in women under the age of 17. Levonorgestrel Tablets, 0.75 mg is the generic equivalent to Duramed Pharmaceuticals' PLAN B(R) (Rx/OTC), which is indicated for the prevention of pregnancy following unprotected intercourse or contraceptive failure. For the 12-months ending June 30, 2009, PLAN B(R) had total U.S. sales of approximately $135 million. Watson will market the product under the trade name Next Choice(TM) and plans to launch the product shortly.
On June 24, 2009, Watson received FDA approval of Next Choice(TM) (levonorgestrel) Tablets, 0.75 mg for prescription use. Following today's approval, Next Choice(TM) is now labeled for both prescription and over-the-counter use.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a global leader in the development and distribution of pharmaceuticals with a broad portfolio of generic products and a specialized portfolio of brand pharmaceuticals focused on Urology, Women's Health and Nephrology/Medical.
For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, the impact of competitive products and pricing; market acceptance of and continued demand for Watson's products; difficulties or delays in manufacturing; the difficulty of predicting the timing or outcome of FDA or other regulatory agency approvals or actions, if any; and other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Quarterly Report on Form 10-Q for the period ended June 30, 2009.
PLAN B(R) is a registered trademark of Women's Capital Corporation, a subsidiary of Duramed Pharmaceuticals, Inc.
SOURCE Watson Pharmaceuticals, Inc.
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