CORONA, Calif., Feb. 13 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), 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 '/>"/>
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