CORONA, Calif., Feb. 13 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (“FDA”) has initiated an inspection of the company’s Florida facilities. No information regarding the duration or outcome of the inspection is known.
Since September 2005, the Davie, Florida manufacturing facility has been under Official Action Indicated (“OAI”). During that time, Watson has continued to file Abbreviated New Drug Applications (“ANDAs”) for product candidates to be manufactured at this site. However, FDA approval of pending ANDAs has been withheld pending positive resolution of the OAI status. While a resolution to the OAI status may enable product candidates to be approved, it does not ensure that any such ANDAs will be approved or, if approved, will be launched. The OAI status does not affect manufacture of products at the Davie, Florida facility that have already been approved for manufacture at that facility, nor does it affect Watson’s other locations.
Watson’s Davie, Florida facility was acquired in November 2006 as part of Watson’s acquisition of Andrx Corporation.
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. For press releases and other company information, visit Watson Pharmaceuticals’ Web site at http://www.watson.com.
Forward-Looking Statement
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, the ability to timely resolve with the FDA the pending Official Action Indicated status of the Davie, Florida manufacturing facility; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; the impact of competitive products and pricing; market acceptance of and continued demand for Watson’s products; difficulties or delays in manufacturing; 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, 2006.
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CONTACT: Patty Eisenhaur of Watson Pharmaceuticals, Inc., +1-951-493-5611
Web site: http://www.watsonpharm.com/
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