FDA Grants Mylan Tentative Approval for Generic Avalide

Mylan Pharmaceuticals received tentative approval from the FDA to market a generic version of the hypertension drug Avalide.

Avalide (hydrochlorothiazide/irbesartan) is marketed by sanofi-aventis and Bristol-Myers Squibb. Last November, the FDA approved the companies’ sNDA for initial use of the drug in patients with hypertension who are likely to need multiple drugs to lower their blood pressure.

The drug had U.S. sales of approximately $288 million for the 12 months that ended March 31, Mylan said. The final patent on the drug expires in 2015, according to the FDA’s Orange Book.

Mylan also received final approval for its ANDA for venlafaxine HCl tablets in 25-, 37.5-, 50-, 75- and 100-mg doses. The tablets are indicated to treat major depressive disorder and are the generic version of Wyeth’s Effexor (venlafaxine HCl) tablets. Effexor had annual U.S. sales of approximately $188 million for the 12 months ending March 31, Mylan said.