Mylan Launches Generic Avapro Tablets and Generic Avalide Tablets

Mylan Inc. 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 Irbesartan Tablets USP, 75 mg, 150 mg and 300 mg, the generic version of Sanofi's Avapro^®. The company also received final approval from the FDA for its ANDA for Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5mg and 300/12.5 mg, the generic version of Sanofi's Avalide®. Irbesartan Tablets are indicated for the treatment of hypertension and in patients with type 2 diabetic nephropathy, and Irbesartan and Hydrochlorothiazide Tablets are indicated for hypertension in patients not adequately controlled with a single drug, and as initial therapy in patients likely to need multiple drugs to achieve blood pressure control.