Watson Receives FDA Approval of Potassium Chloride Extended-Release Capsules

Watson Pharmaceuticals, Inc. (NYSE:WPI) , a leading specialty pharmaceutical company, announced recently that it has received approval from the U.S. Food and Drug Administration (“FDA”) of its Abbreviated New Drug Application (ANDA) for Potassium-Chloride Extended-Release Capsules USP in the 8mEq and 10mEq strengths. Potassium-Chloride is the generic equivalent to KV Pharmaceutical’s Micro-K(R) Extencaps(R) USP and is indicated for the treatment of patients with hypokalemia, with or without metabolic alkalosis, in digitalis intoxications, and in patients with hypokalemic familial periodic paralysis. For the 12-months ending March 2008, Micro-K(R) Extencaps(R) and its generic equivalents had total U.S. sales of approximately $80 million, according to IMS Health. Watson plans to launch its Potassium Chloride Extended-Release product during the third quarter of 2008. The specific launch date will depend upon the timing of product validation activities and manufacturing of launch quantities.