FDA Approves Potassium Chloride Extended-Release Capsules
Watson Pharmaceuticals has received approval from 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 Extencaps 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 Extencaps 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.