Healthcare Industry News:  Mylan 

Biopharmaceuticals Generics FDA

 News Release - June 16, 2008

Mylan Announces Final FDA Approval for Generic Version of Antidepressant Effexor(R)

PITTSBURGH, June 16 (HSMN NewsFeed) -- Mylan Inc. (NYSE: MYL ) today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Venlafaxine Hydrochloride (HCl) Tablets 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base) and 100 mg (base).

Venlafaxine HCl Tablets, indicated for the treatment of major depressive disorder, are the generic version of Wyeth's EffexorŽ Tablets, which had annual U.S. sales of approximately $188 million for the 12 months ending March 31, 2008.

This product is shipping immediately. Currently, Mylan has 92 ANDAs pending FDA approval, 20 of which are potential first-to-file opportunities.

Mylan Inc., with a presence in more than 90 countries, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest - and highest quality - product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.


Source: Mylan

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