CORONA, Calif., April 29 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (“FDA”) has completed the inspection of the company’s Florida manufacturing facilities and has informed the Company that it has removed the Official Action Indicated (“OAI”) status at Watson’s Davie, Florida site. As a result of this action, and subject to satisfying other FDA approval criteria, Abbreviated New Drug Applications (ANDAs) for products at this site are now eligible for FDA approval.
The FDA completed the onsite portion of its inspection on April 10, 2008, at which time it issued a Form 483 List of Inspectional Observations. The Company responded to the Form 483 Inspectional Observations on April 17, 2008.
Since 2005, the Davie, Florida manufacturing facility has been under OAI status. During that time, Watson has continued to file 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. Watson is working closely with FDA to obtain approval of pending ANDAs eligible for final approval.
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, risks related to our successful compliance with extensive, costly, complex, and evolving governmental regulations and restrictions; the possibility that FDA may not agree with Watson’s responses to the Form 483 list of inspectional observations; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; 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, 2007.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO)
CONTACT: Patty Eisenhaur of Watson Pharmaceuticals, Inc., +1-951-493-5611
Web site: http://www.watson.com/
