Aurobindo receives final FDA Approval for Amiodarone Hydrochloride Tablets, 200 mg

Dayton, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Amiodarone Hydrochloride Tablets, 200 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Amiodarone Hydrochloride Tablets, 200 mg, to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), Cordarone® of Wyeth Pharmaceuticals Inc.

Amiodarone Hydrochloride Tablets, 200 mg. is indicated for the treatment of recurrent ventricular fibrillation and recurrent hemodynamically unstable ventricular tachycardia (treat a heart rhythm problem).

The approved Amiodarone Hydrochloride Tablets, 200 mg product has an estimated market size of $24.1 M for the twelve months ending 2016 according to IMS*.
Amiodarone Hydrochloride Tablets, 200 mg. represents the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 231 final approvals, including 38 tentative approvals. There are 107 additional products on file with U.S. FDA.
* IMS National Sales Perspectives: Retail and Non-Retail MAT June 2016