CORONA, Calif., June 3 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today 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.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.
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Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, difficulties or delays in manufacturing; the impact of competitive products and pricing; market acceptance of and continued demand for Watson's products; and other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Annual Report on Form 10-K for the year ended December 31, 2007.
SOURCE Watson Pharmaceuticals, Inc.