Aurobindo Receives FDA Approval for Amlodipine and Valsartan Tablets USP, 5 mg/160 mg; 10 mg/160 mg; 5 mg/320 mg; 10 mg/320 mg

Dayton, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Amlodipine and Valsartan Tablets USP, 5 mg/160 mg; 10 mg/160 mg; 5 mg/320 mg; 10 mg/320 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Amlodipine and Valsartan Tablets USP, to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), Exforge® Tablets of Novartis Pharmaceuticals Corporation.

Amlodipine and Valsartan Tablets USP, 5 mg/160 mg; 10 mg/160 mg; 5 mg/320 mg; 10 mg/320 mg are used in the treatment of hypertension to lower blood pressure.

The product has an estimated market size of $87.0M for the twelve months ending February 2016 according to IMS*.

Amlodipine and Valsartan Tablets USP, 5 mg/160 mg; 10 mg/160 mg; 5 mg/320 mg; 10 mg/320 mg represents the latest addition to Aurobindo’s broad line of vertically integrated pharmaceuticals. Aurobindo’s product portfolio consists of 214 final approvals, including 34 tentative approvals and 10 from Aurolife Pharma LLC. There are 119 additional products on file with U.S. FDA.

* IMS National Sales Perspectives: Retail and Non-Retail MAT February 2016