FDA tentatively approves Mylan generic hypertension drug
Mylan has reported that its subsidiary, Mylan Pharmaceuticals, has received tentative approval from the 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 tablets, which had U.S. sales of approximately $288 million for the 12 months ending March 31, according to IMS Health.

Currently, the Pittsburgh-based Mylan has 92 ANDAs pending FDA approval, 20 of which are potential first-to-file opportunities.