Teva's generic Effexor XR receives regulatory approval

SILVER SPRING, Md. The Food and Drug Administration has approved the first generic version of an extended-release antidepressant pill made by Pfizer, the agency said Tuesday.

The FDA approved Teva Pharmaceutical Industries’ venlafaxine hydrochloride extended-release capsules. The capsules are a generic version of Effexor XR, used to treat major depressive disorder. The capsules will be available in the 37.5 mg, 75 mg and 150 mg strengths.

“The approval of this widely used antidepressant is another example of the FDA’s efforts to increase access to safe and effective generic drugs,” said Keith Webber, FDA Center for Drug Evaluation and Research Office of Pharmaceutical Science deputy director. “Access to treatments for depression is important because depression can interfere with a person’s daily life and routine, which can significantly affect relationships with family and friends.”

Effexor products had sales of $520 million in 2009, according to Pfizer financial data.

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