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.
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