Wyeth: FDA done with Guayama inspection |
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Thu, 05 Apr 2007 15:44
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MADISON, N.J. (AP) - Drug maker Wyeth said Wednesday that the Food and Drug Administration finished inspecting one of its plants in Guayama, Puerto Rico, bringing it closer to final approval for its newest antidepressant.The FDA inspection covered deficiencies outlined in a May 2006 warning letter, where the agency found manufacturing practices for several products out of code. Wyeth plans to respond to observations found in the new FDA inspection by mid-April to get the facility into compliance. The company said the Guayama plant received a positive evaluation from European inspectors in March.In January, the FDA approved Wyeth's depression treatment Pristiq on a conditional basis, with the inspection of the Guayama plant one of the conditions for final approval.Wyeth plans to provide product updates during its April 19 earnings conference call.Shares of Wyeth rose 52 cents to $53 in morning trading on the New York Stock Exchange.Copyright 2007 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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