Aurobindo Receives FDA Approval for Dalfampridine Extended-Release Tablets, 10 mg

 

January 25, 2017

 

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Dalfampridine Extended-Release Tablets, 10 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Dalfampridine Extended-Release Tablets, 10 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), Amprya® of Acorda Therapeutics, Inc.

Dalfampridine Extended-Release Tablets, 10 mg is indicated for the treatment of multiple sclerosis (MS).

The product has an estimated market size of $347M for the twelve months ending November 2016 according to IMS*. 

Dalfampridine Extended-Release Tablets, 10 mg represents the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 256 final approvals, including 39 tentative approvals, and 16 approved products from Aurolife. There are 97 additional products on file with U.S. FDA.

 

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