Go-ahead granted for Wyeth's antidepressant Pristiq

March 5, 2008

Desvenlafaxine is approved by FDA for depression in adults.

Desvenlafaxine (Wyeth Pharmaceuticals, has been approved for marketing as a treatment for major depressive disorder in adults. The serotonin-norepinephrine reuptake inhibitor (SNRI) does not require titration, according to the manufacturer, and is approved as a once-daily 50-mg dose. Desvenlafaxine delivers the active metabolite venlafaxine (Effexor XR, Wyeth) in its active state without first going through the CYP2D6 metabolic pathway. Wyeth has agreed to conduct several postmarketing studies in several areas: relapse prevention, pediatrics, sexual dysfunction, lower dosing, and a non-clinical toxicity study. Wyeth said the new product will be rolled out during the second quarter of 2008.

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