Watson Pharmaceuticals Receives FDA Approval For Generic PLAN B(R)

Main Category: Fertility
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 04 Jul 2009 - 2:00 PDT

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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 on its Abbreviated New Drug Application (ANDA) for levonorgestrel tablets, 0.75 mg, for women seventeen years and younger. Levonorgestrel is the generic equivalent to Duramed Pharmaceuticals' PLAN B(R), which is indicated for the prevention of pregnancy following unprotected intercourse or contraceptive failure. This product is approved for prescription use only. The Company intends to market the product under the trade name Next Choice(TM) and plans to launch the product shortly. For the 12-months ending March 2009, PLAN B(R) had total U.S. sales of approximately $123 million, of which approximately ten percent are attributable to prescription sales, according to IMS sales data. PLAN B(R) over-the-counter (O.T.C.) new product exclusivity expires on August 24, 2009.

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.

Forward-Looking Statement

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 Annual Report on Form 10-K for the year ended December 31, 2008.

PLAN B(R) is a registered trademark of Women's Capital Corporation, a subsidiary of Duramed Pharmaceuticals, Inc.

SOURCE Watson Pharmaceuticals, Inc.