FDA Bounces Request to Approve Desvenlafaxine (Pristiq) for Menopause

Pfizer Inc. reports that it has received a "complete response letter" from the Food and Drug Administration (FDA) denying its application to approve desvenlafaxine (Pristiq) for moderate to severe vasomotor symptoms of menopause such as hot flashes. The drug, a selective serotonin reuptake inhibitor, is currently approved for the treatment of major depressive disorder in adults.

A complete response letter states that an application for a new drug indication cannot be approved in its current form. Neither Pfizer nor FDA has released further details. Pfizer plans to pursue the application further.

Several clinical studies have shown desvenlafaxine more effective than placebo against hot flashes. One of them, a multicenter randomized trial involving more than 700 women, was published in 2008 in the journal Obstetrics and Gynecology.

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