Tentative OK for Watson’s New Salt Form of Cholesterol Medication Crestor

Watson Pharmaceuticals Inc. Aug. 10 announced that its subsidiary, Watson Laboratories Inc., has received tentative approval from the Food and Drug Administration for its rosuvastatin zinc tablets in 5 mg, 10 mg, 20 mg, and 40 mg.

Watson’s rosuvastatin zinc tablets are a new salt form of AstraZeneca’s cholesterol drug Crestor (rosuvastatin calcium).

On July 15, 2010, Watson Laboratories filed a new drug application (NDA) with FDA seeking approval to market the product. Watson said it filed the application under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, seeking approval to market rosuvastatin zinc 5 mg, 10 mg, ...