CORONA, Calif., Feb. 13 Watson Pharmaceuticals,Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced todaythat the U.S. Food and Drug Administration ("FDA") has initiated an inspectionof the company's Florida facilities. No information regarding the duration oroutcome of the inspection is known.
Since September 2005, the Davie, Florida manufacturing facility has beenunder Official Action Indicated ("OAI"). During that time, Watson hascontinued to file Abbreviated New Drug Applications ("ANDAs") for productcandidates to be manufactured at this site. However, FDA approval of pendingANDAs has been withheld pending positive resolution of the OAI status. While aresolution to the OAI status may enable product candidates to be approved, itdoes not ensure that any such ANDAs will be approved or, if approved, will belaunched. The OAI status does not affect manufacture of products at the Davie,Florida facility that have already been approved for manufacture at thatfacility, nor does it affect Watson's other locations.
Watson's Davie, Florida facility was acquired in November 2006 as part ofWatson's acquisition of Andrx Corporation.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leadingspecialty pharmaceutical company that develops, manufactures, markets, sellsand distributes brand and generic pharmaceutical products. Watson pursues agrowth strategy combining internal product development, strategic alliancesand collaborations and synergistic acquisitions of products and businesses.For press releases and other company information, visit WatsonPharmaceuticals' Web site at http://www.watson.com.
Any statements contained in this press release that refer to future eventsor other non-historical facts are forward-looking statements that reflectWatson's current perspective of existing trends and information as of the dateof this release. Except as expressly required by law, Watson disclaims anyintent or obligation to update these forward-looking statements. Actualresults may differ materially from Watson's current expectations dependingupon a number of factors affecting Watson's business. These factors include,among others, the ability to timely resolve with the FDA the pending OfficialAction Indicated status of the Davie, Florida manufacturing facility; thedifficulty of predicting the timing or outcome of product development effortsand FDA or other regulatory agency approvals or actions; the impact ofcompetitive products and pricing; market acceptance of and continued demandfor Watson's products; difficulties or delays in manufacturing; and otherrisks and uncertainties detailed in Watson's periodic public filings with theSecurities and Exchange Commission, including but not limited to Watson'sAnnual Report on Form 10-K for the year ended December 31, 2006.
SOURCE Watson Pharmaceuticals, Inc.