Lupin, a Rs.6,950 crore Mumbai based pharma major announced that its subsidiary Lupin Pharmaceuticals Inc. has received final approval for its Valsartan and hydrochlorothiazide tablets USP, 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg and  320 mg/25 mg from the United States Food and Drugs Administration (US FDA) to market a generic version of Novartis’ Diovan HCT tablets, 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg  and 320 mg/25 mg, respectively. Lupin has already commenced shipping the product.

Lupin’s Valsartan and hydrochlorothiazide tablets USP is indicated for the treatment of hypertension, to lower blood pressure in patients not adequately controlled with monotherapy or as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

Valsartan and hydrochlorothiazide tablets USP, 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg had annual US sales of approximately USD 1.7 billion (IMS MAT Sept 2012 sales).