FDA Approval Of Wyeth Menopause Treatment Pristiq Delayed

Main Category: Menopause
Also Included In: Endocrinology;  Seniors / Aging
Article Date: 25 Apr 2007 - 12:00 PST

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Wyeth on Thursday said that regulatory approval of its new drug, Pristiq, a nonhormonal treatment for hot flashes and other menopause symptoms, is delayed until at least July to give FDA time to review new data on the drug, the AP/Forbes reports. FDA was scheduled to decide whether to approve Pristiq next week. The drug is a new version of Wyeth's depression treatment Effexor, which will lose patent protection in 2010. According to the AP/Forbes, Wyeth is seeking approval from FDA to market Pristiq as a depression treatment for older women, as well as a treatment for menopause symptoms. FDA's review of the drug as a depression treatment also will be delayed (Perrone, AP/Forbes, 4/19). Company officials in a conference call with analysts on Thursday said that they are sending FDA data showing effectiveness but improved tolerability for a lower dose, 50-milligram dose of Pristiq, Reuters reports. The company expects that Pristiq will be approved to treat hot flashes in the third quarter of 2007 but that approval to treat depression will not come until the first quarter of 2008 (Reuters, 4/19).

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