FDA asks Wyeth for more drug study data |
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Tue, 24 Apr 2007 21:21
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COLLEGEVILLE, Pa. (AP) - Wyeth Pharmaceuticals, a division of drug developer Wyeth, said Tuesday the Food and Drug Administration requested final late-stage study data on bazedoxifene before it can consider the drug candidate for approval.Wyeth is seeking clearance of bazedoxifene for prevention of postmenopausal osteoporosis. Wyeth said it expected the FDA's approvable letter request.The FDA asked for final safety and effectiveness data from a finished Phase III clinical trial. The FDA also has to finish evaluating the manufacturing facilities for the drug.The FDA concluded a reinspection of Wyeth's Guayama, Puerto Rico, facility in early April.'We believe the situation at the Guayama facility will be resolved without affecting the timing of new product launches,' Wyeth said in a statement.Wyeth said while it is addressing the requests from the FDA letter, it will also seek an additional approval to treat postmenopausal osteoporosis later this year.Citing figures from the North American Menopause Society, the company said there are about 40 million women in the U.S. of menopausal age.Shares of Wyeth fell 20 cents to close at $55.53 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 This material may not be published, broadcast, rewritten, or redistributed.
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FDA decision on new Wyeth drug postponed 