Watson's Rosuvastatin Zinc Tablets Receive Tentative FDA Approval

MORRISTOWN, N.J., Aug. 10, 2011 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary, Watson Laboratories, Inc., has received tentative approval from the United States Food and Drug Administration (FDA) for its rosuvastatin zinc 5, 10, 20 and 40 mg tablets. Watson's rosuvastatin zinc tablets are a new salt form of AstraZeneca's Crestor® (rosuvastatin calcium) tablets.

On July 15, 2010, Watson Laboratories, Inc., filed a New Drug Application (NDA) under Section 505(b)(2) of the Federal Food and Drug Cosmetic Act (FFDCA) with the United States Food and Drug Administration (FDA) seeking approval to market rosuvastatin zinc 5, 10, 20 and 40 mg tablets.

AstraZeneca filed suit against Watson on October 26, 2010 in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of United States Patent No. RE 37,314.  AstraZeneca's lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's NDA until April 1, 2013 or until final resolution of the matter before the court, whichever occurs sooner.  

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, ; the difficulty of predicting the timing or outcome of pending patent litigation concerning the rosuvastatin zinc product and potential damages related thereto; the difficulty of predicting the timing and success of product launches, if any; the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any the impact of competitive products and pricing; 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 June 30, 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.

Crestor® is a registered trademark of the AstraZeneca group of companies.

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CONTACTS:

Investors:


Patty Eisenhaur


(862) 261-8141




Media:


Charlie Mayr


(862) 261-8030



SOURCE Watson Pharmaceuticals, Inc.

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