East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Prasugrel Tablets, 5 mg and 10 mg
The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Prasugrel Tablets, 5 mg and 10 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug Effient®
Prasugrel tablets are indicated to reduce the rate of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS).
The product has an estimated market size of $685.3M for the twelve months ending August 2017 according to IMS*.
Prasugrel Tablets, 5 mg and 10 mg represent the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 280 final approvals, including 37 tentative approvals, and 16 approved products from Aurolife. There are 119 additional products on file with U.S. FDA.
* IMS National Sales Perspectives: Retail and Non-Retail MAT August 2017