MORRISTOWN, N.J., Oct. 27 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed a new drug application under Section 505(b)(2) of the Federal Food and Drug Cosmetic Act (FFDCA) with the U.S. Food and Drug Administration (FDA) seeking approval to market rosuvastatin zinc 5, 10, 20 and 40 mg tablets. Watson's rosuvastatin zinc tablets are a new salt version of AstraZeneca's Crestor ® tablets. Crestor® is indicated, as an adjunct to diet, to lower LDL cholesterol, raise HDL cholesterol, and slow the progression of atherosclerosis.
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 U.S. 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 March 30, 2013 or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
For the twelve months ending June 30, 2010, Crestor ® had total U.S. sales of approximately $3.5 billion according to IMS Health data.
About Watson Pharmaceuticals, Inc.Watson Pharmaceuticals, Inc. is a leading 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.
|SOURCE Watson Pharmaceuticals, Inc.|
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