Wyeth Withdraws Marketing Authorization Application of Vasomotor Drug
Posted on: Thursday, 13 March 2008, 09:00 CDT
Wyeth Europa has notified the European Medicines Agency of its decision to withdraw the application for a centralized marketing authorization for the medicine Pristiqs 50mg and 100mg prolonged release tablets.
In its official letter, the company stated that the withdrawal of Pristiqs was based on its plans to conduct additional clinical studies that would address the Committee for Medicinal Products for Human Use's (CHMP) questions regarding the benefit-risk profile of Pristiqs as a treatment for vasomotor symptoms.
Pristiqs was expected to be used for the treatment of vasomotor symptoms associated with menopause. The application for marketing authorization for Pristiqs was submitted to the European Medicines Agency (EMEA) on October 4, 2006. At the time of the withdrawal, it was under review by the Agency's CHMP.
Source: Datamonitor
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