Watson's rosuvastatin zinc pills earn tentative FDA approval

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Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has received tentative approval from the FDA for its rosuvastatin zinc 5, 10, 20 and 40 mg tablets. Watson's rosuvastatin zinc tablets are a salt form of AstraZeneca's Crestor (rosuvastatin calcium) tablets.

On July 15, 2010, Watson, of Morristown, N.J., filed a new drug application (NDA) under Section 505(b)(2) of the Federal Food and Drug Cosmetic Act with the FDA seeking approval to market rosuvastatin zinc 5, 10, 20 and 40 mg tablets.

The London-based AstraZeneca filed suit against Watson on Oct. 26, 2010, in the U.S. 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 April 1, 2013, or until final resolution of the matter before the court, whichever occurs sooner.