Mylan announced that it has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Irbesartan Tablets, the generic version of Sanofi‘s Avapro, and for Irbesartan and Hydrochlorothiazide Tablets, the generic version of Sanofi‘s Avalide.
Irbesartan is indicated for the treatment of hypertension and in patients with type 2 diabetic nephropathy. Irbesartan and Hydrochlorothiazide is indicated for the treatment of 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.
Irbesartan Tablets are available in 75mg, 150mg and 300mg dosage strength tablets. Irbesartan and Hydrochlorothiazide Tablets are available in 150mg/12.5mg and 300mg/12.5mg dosage strength tablets. Mylan is shipping both products immediately.
For more information call (800) RX-MYLAN or visit www.mylan.com.