Mylan announced that it has received final FDA approval for its Abbreviated New Drug Application (ANDA) for Valsartan and Hydrochlorothiazide Tablets, the generic version of Novartis‘ Diovan HCT tablets.
Valsartan and Hydrochlorothiazide Tablets are indicated for the treatment of hypertension in patients not adequately controlled with monotherapy or as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. It is a combination of valsartan, an angiotensin II receptor blocker, and hydrochlorothiazide, a diuretic.
Valsartan and Hydrochlorothiazide Tablets will be available in 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg dosage strengths. Mylan will have 180 days of marketing exclusivity and is shipping this product immediately.
For more information call (800) RX-MYLAN or visit www.mylan.com.