FDA approves two generic hypertension drugs from Mylan

Drug maker to launch drugs immediately

PITTSBURGH — Generic drug maker Mylan has received regulatory approval for a drug used to treat high blood pressure, also known as hypertension, the company said Friday, saying that it would launch both drugs immediately.

Mylan said the Food and Drug Administration approved its irbesartan tablets in the 75 mg, 150 mg and 300 mg strengths and irbesartan and hydrochlorothiazide tablets in the 150 mg/12.5 mg and 300 mg/12.5 mg strengths. The drugs are respectively generic versions of Sanofi's Avapro and Avalide.

Avapro is used to treat hypertension in patients with Type 2 diabetic nephropathy, while Avalide is used to treat hypertension in patents whose disease is inadequately controlled with a single drug or who are first starting therapy and need multiple drugs to control blood pressure.

Irbesartan tablets had sales of about $400.7 million during the 12-month period ending in June 2012, while irbesartan and hydrochlorothiazide tablets had sales of about $117.4 million during the same time, according to IMS Health.


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