Business Update

Mylan receives U.S. FDA tentative approval for generic drug for depressive disorder

Published in Medical Letter on the CDC and FDA, September 17th, 2006

Mylan Laboratories Inc. (MYL) announced that the U.S. Food and Drug Administration has granted tentative approval for Mylan Pharmaceuticals Inc.'s abbreviated new drug application for Venlafaxine hydrochloride tablets 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base) and 100 mg (base).

Venlafaxine HCl tablets are indicated for the treatment of major depressive disorder. They are the AB-rated generic version of Wyeth's Effexor tablets, which had annual U.S. sales of approximately $154 million for the 12 months ending June 30, 2006.

Mylan Laboratories Inc. is a pharmaceutical company with three principal subsidiaries: Mylan Pharmaceuticals Inc.,...

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Source: Medical Letter on the CDC and FDA (2006-09-17)

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