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Wyeth withdraws application for desvenlafaxine in Europe

Madison, New JerseyFriday, March 14, 2008, 08:00 Hrs  [IST]

Wyeth Pharmaceuticals, a division of Wyeth, had pulled its application for European Marketing Authorisation for desvenlafaxine for the treatment of vasomotor symptoms (hot flashes) associated with menopause. Wyeth withdrew the application in order to conduct additional clinical studies to address questions from the Committee for Medicinal Products for Human Use (CHMP) regarding the risk-benefit profile of desvenlafaxine as a treatment for vasomotor symptoms. "We believe that desvenlafaxine can provide women with a non-hormonal option to treat vasomotor symptoms (VMS), and Wyeth remains committed to developing the molecule for this indication," said Gary L. Stiles, M.D., executive vice president and chief medical officer, Wyeth Pharmaceuticals. "Some of the questions raised by the CHMP can be addressed with our planned clinical trials, including the 12-month study Wyeth is initiating with post-menopausal women early this year. The company is also considering whether to conduct additional studies."

 
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