Wyeth says get approvable letter from FDA for Pristiq |
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Tue, 24 Jul 2007 13:13
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LONDON (Thomson Financial) - Wyeth Pharmaceuticals, a division of Wyeth, said it received an approvable letter from the U.S. Food and Drug Administration (FDA) for Pristiq, a serotonin-norepinephrine reuptake inhibitor, currently under review as a treatment for moderate-to-severe hot flashes and night sweats associated with menopause.In the letter, the FDA said that before the application could be approved, it would be necessary for Wyeth to provide additional data regarding the potential for serious adverse cardiovascular and hepatic effects associated with the use of Pristiq.Wyeth said the agency requested that these data come from a randomised, placebo-controlled clinical trial of a duration of one year or more conducted in postmenopausal women.The agency also requested that Wyeth address certain chemistry, manufacturing and controls deficiencies prior to approval.tf.TFN-Europe_newsdesk@thomson.comrwCOPYRIGHTCopyright AFX News Limited 2007. All rights reserved.The copying, republication or redistribution of AFX News Content, including by framing or similar means, is expressly prohibited without the prior written consent of AFX News.
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FDA stops short of approving Pristiq 