Aurobindo Receives FDA Approval for Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Azor® of Daiichi Sankyo, Inc.

Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg is indicated in for the treatment of hypertension.

The product has an estimated market size of $255.8M for the twelve months ending March 2017 according to IMS*.

Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg represents the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 262 final approvals, including 36 tentative approvals, and 16 approved products from Aurolife. There are 104 additional products on file with U.S. FDA.

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