Business Update

U.S. FDA grants approval for generic equivalent of Effexor tablets for depressive disorder

Published in Medical Letter on the CDC and FDA, September 10th, 2006

Teva Pharmaceutical Industries Ltd. (TEVA) announced that the U.S. Food and Drug Administration (FDA) has granted final approval for the company's abbreviated new drug application (ANDA) for Venlafaxine hydrochloride tablets, 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg.

Teva's Venlafaxine HCl tablets are the AB-rated generic equivalent of Wyeth's Effexor tablets, a product indicated for the treatment of major depressive disorder.

The brand product has annual sales of approximately $152 million.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, develops and manufactures human pharmaceuticals and active pharmaceutical...

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Source: Medical Letter on the CDC and FDA (2006-09-10)

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