Mylan (MYL) Pharmaceuticals Receives Final FDA Approval for Generic Effexor(R) and Tenative FDA Approval for Generic Version of Avalide(R)

June 16, 2008 2:25 PM EDT

Mylan Inc. (NYSE: MYL) today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received final approval from the U.S. FDA for its Abbreviated New Drug Application for Venlafaxine Hydrochloride Tablets 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg. The tablets are the generic version of Wyeth's Effexor(R), which had annual sales of about $188 million for the 12 months ending March 31, 2008.

Mylan Pharmaceuticals has also announced today that it has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for Irbesartan and Hydrochlorothiazide Tablets, 150 mg/12.5 mg and 300 mg/12.5 mg. The tablets are the generic version of Sanofi Aventis' Avalide(R) Tablets, which had U.S. sales of approximately $288 million for the 12 months ending March 31, 2008.

Mylan, Inc. and its subsidiaries engage in the development, manufacture, marketing, licensing, and distribution of generic, brand, and branded generic pharmaceutical products, as well as active pharmaceutical ingredients.

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