Mylan Pharmaceuticals has won FDA approval for its abbreviated new drug application (ANDA) for Irbesartan Tablets USP, 75mg, 150mg and 300mg, the generic version of Sanofi's Avapro.
The FDA has also approved the company's ANDA for Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5mg and 300/12.5 mg, the generic version of Sanofi's Avalide.
The company announced the immediate shipment of both the products.
Irbesartan Tablets are indicated to treat hypertension and in patients with type 2 diabetic nephropathy.
Irbesartan and Hydrochlorothiazide Tablets are used to treat 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.
According to IMS Health, for the 12 months ending 30 June 2012, Irbesartan Tablets USP, 75mg, 150mg and 300mg, had US sales of $400.7m, and Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5mg and 300/12.5 mg, had US sales of $117.4m.
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