Watson's Rosuvastatin Zinc Tablets Receive Tentative FDA Approval

Watson Pharmaceuticals, Inc. WPI today announced that its subsidiary, Watson Laboratories, Inc., has received tentative approval from the United States Food and Drug Administration 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 tablets. On July 15, 2010, Watson Laboratories, Inc., filed a New Drug Application under Section 505(b)(2) of the Federal Food and Drug Cosmetic Act with the United States Food and Drug Administration seeking approval to market rosuvastatin zinc 5, 10, 20 and 40 mg tablets. AstraZeneca AZN 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.