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Watson's Generic Lybrel? Receives FDA Approval

Tuesday, June 07, 2011 8:02 AM

PARSIPPANY, N.J., June 7, 2011 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for Levonorgestrel and Ethinyl Estradiol Tablets, USP, 0.09 mg/0.02 mg, the generic equivalent to Pfizer's Lybrel® tablets. Watson expects to launch the product shortly.

(Logo: http://photos.prnewswire.com/prnh/20100121/LA41294LOGO )

Lybrel® had total U.S. sales of just under $12 million for the twelve months ending April 30, 2011, according to IMS Health.  Lybrel® tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc. is an integrated global specialty pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. Watson has operations in many of the world's established and growing international markets.

For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.

Forward-Looking Statement

Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson's current perspective of existing information as of the date of this release. It is important to note that Watson's goals and expectations are not predictions of actual performance. Actual results may differ materially from Watson's current expectations depending upon a number of factors, risks and uncertainties affecting Watson's business. These factors include, among others, risks of third party claims alleging infringement of patents or other intellectual property rights; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Watson and its third party manufacturers' facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such 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 quarter ended March 31, 2011 and Watson's annual report on Form 10-K for the year ended December 31, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.

Lybrel® is a registered trademark of Pfizer, Inc.

CONTACTS:

Investors:


Patty Eisenhaur


(862) 261-8141




Media:


Charlie Mayr


(862) 261-8030



SOURCE Watson Pharmaceuticals, Inc.

(Source: PR Newswire )
(Source: Quotemedia)

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