CORONA, Calif., Nov. 22 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that it has received final approval from the United States (U.S.) Food and Drug Administration (FDA) on its Abbreviated New Drug Application for levonorgestrel and ethinyl estradiol tablets USP, 0.1mg / 0.02mg, a generic version of Wyeth’s Alesse(R), which is indicated for the prevention of pregnancy.
The Company intends to initiate shipments of the product immediately under the trade name LUTERA(TM). For the 12-months ending September 2004, the levonorgestrel and ethinyl estradiol tablets USP, 0.1mg / 0.02mg market had total U.S. sales of approximately $163 million, according to IMS Health data.
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 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, 2003 and Quarterly Reports on Form 10-Q for the quarters ended March 31, June 30 and September 30, 2004.
Alesse(R) is a registered trademark of Wyeth’s.
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CONTACT: Investors, Patty Eisenhaur, +1-951-493-5611, or Media, ChrisEso, +1-951-493-4013, both of Watson Pharmaceuticals, Inc.
Web site: http://www.watsonpharm.com/
