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FDA Okays Generic Versions of Sanofi’s Avapro and Avalide

Both drugs will be available immediately (Sept. 28)

Mylan Inc., based in Pittsburgh, Pa., announced on September 28 that its subsidiary, Mylan Pharmaceuticals Inc., has received final approval from the 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 (HCTZ) tablets USP, 150/12.5 mg and 300/12.5 mg — the generic version of Sanofi's Avalide.

Irbesartan tablets are indicated for the treatment of hypertension and type 2 diabetic nephropathy. Irbesartan and HCTZ tablets are indicated for the treatment of hypertension in patients who are not adequately controlled with a single drug, and as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure control.

Irbesartan tablets USP, 75 mg, 150 mg and 300 mg, had U.S. sales of approximately $400.7 million for the 12 months ending on June 30, 2012, and irbesartan and HCTZ tablets USP, 150/12.5 mg and 300/12.5 mg, had U.S. sales of approximately $117.4 million, according to IMS Health.

Mylan is shipping both products immediately.

For more information visit, the Mylan, Inc. Web site.

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