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Wyeth-Ayerst’s Effoxor

Executive Summary

Venlafaxine NDA is "approvable" Nov. 8. On April 30, FDA's Psychopharmacologic Drugs Advisory Committee agreed 8-0 with one abstention that Effexor is an effective acute treatment of depression, and voted 7-0 with two abstentions that Effexor is safe for that use. The committee also suggested that Effexor labeling should discuss blood pressure elevation possibly associated with the drug ('The Pink Sheet" May 3, p. 10).
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PS023618

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