CORONA, Calif., May 9 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced that it has received tentative approval today from the United States (U.S.) Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for levonorgestrel / ethinyl estradiol tablets USP, 0.15 mg / 0.03 mg.
Levonorgestrel / ethinyl estradiol tablets USP is the generic equivalent to Duramed Pharmaceuticals' Seasonale(R) tablets, which is indicated for prevention of pregnancy. For the 12-months ending March 2006, Seasonale(R) had total U.S. sales of approximately $104 million, according to IMS Health data.
Final approval of this product is expected following the expiration of Duramed's market exclusivity on September 5, 2006.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.
For press releases and other company information, visit Watson Pharmaceuticals' Web site at http://www.watsonpharm.com.
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 difficulty of predicting the timing or outcome of product development efforts and FDA approvals or actions; successful compliance with FDA and other governmental regulations applicable to Watson's and its third party manufacturers' facilities, products and/or businesses; the impact of competitive products and pricing; market acceptance of and continued demand for Watson's products; difficulties or delays in manufacturing; 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, 2005.
Seasonale(R) is a registered trademark of Duramed Pharmaceuticals, Inc.
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