Wyeth: FDA cancels meeting to discuss NDA for depression treatment, action letter expected in October

By Lisa Kerner

Charlotte, N.C., Aug. 22 - The Food and Drug Administration cancelled its Sept. 7 Psychopharmacologic Drugs Advisory Committee meeting to review Wyeth's New Drug Application for desvenlafaxine succinate extended release for the treatment of major depressive disorder.

According to a news release, the FDA reviewed the data and found it was no longer necessary to hold the advisory committee meeting before issuing its action letter, which is expected in October.

Wyeth said it believes its comprehensive clinical trials program for its dual serotonin-norepinephrine reuptake inhibitor supports the product's approval.

Depression, the most common serious mental disorder worldwide, affects about 121 million people and is the fourth leading cause of disability and premature death.

Wyeth is a research-driven pharmaceutical and health care products company based in Madison, N.J.

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