Mylan Announces FDA Approval Of Avapro, Avalide Generics

Mylan Inc. Sept. 28 announced that its subsidiary, Mylan Pharmaceuticals Inc., has received final approval from the Food and Drug Administration for its generic version of Avapro (irbesartan) 75 mg, 150 mg, and 300 mg tablets.

The company also said FDA has approved its generic version of Avalide (irbesartan and hydrochlorothiazide) 150/12.5 mg and 300/12.5 mg tablets.

Avapro and Avalide are made by New York-based Bristol-Myers Squibb and Paris-based Sanofi. Avapro is indicated for treating hypertension and also is indicated to treat patients with type 2 diabetic nephropathy, Mylan said. Avalide is indicated for hypertension in patients not adequately controlled ...