April 29, 2008 — /PRNewswire/ — CORONA, CA — 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, FL 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 on-site 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, FL 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.