Mylan announces FDA approval for generic Effexor and tentative approval for generic antihypertensive Avalide

Jun 16 2008

Mylan Inc. 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 Effexor(R) 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 has also announced that its subsidiary, Mylan Pharmaceuticals Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Irbesartan and Hydrochlorothiazide Tablets, 150 mg/12.5 mg and 300 mg/12.5 mg.

Irbesartan and Hydrochlorothiazide Tablets, indicated for the treatment of hypertension, 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, according to IMS Health.