East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP, 5 mg/160 mg/12.5 mg, 5 mg/160 mg/25 mg, 10 mg/160 mg/12.5 mg, 10 mg/160 mg/25 mg, and 10 mg/320 mg/25 mg. Aurobindo’s Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP are an AB-rated generic equivalent to the reference listed drug Exforge®.

Amlodipine, Valsartan and Hydrochlorothiazide Tablets are indicated for the treatment of hypertension, to lower blood pressure.

The product has an estimated market size of $44.9M for the twelve months ending October 2017 according to IMS*.

Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP represent the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 287 final approvals, including 36 tentative approvals, and 17 approved products from Aurolife. There are 115 additional products on file with U.S. FDA.

* IMS National Sales Perspectives: Retail and Non-Retail MAT October 2017