East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Olmesartan Medoxomil Tablets, 5 mg, 20 mg, and 40 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Olmesartan Medoxomil Tablets, 5 mg, 20 mg, and 40 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), BENICAR® of Daiichi Sankyo, Inc.
Olmesartan Medoxomil Tablets, 5 mg, 20 mg, and 40 mg is indicated for the treatment of hypertension*.
The product has an estimated market size of $981.7M for the twelve months ending February 2017, according to IMS**.
Olmesartan Medoxomil Tablets 5 mg, 20 mg, and 40 mg, represents the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 261 final approvals, including 36 tentative approvals, and 16 approved products from Aurolife. There are 105 additional products on file with U.S. FDA.
* For more information, please see Full Prescribing Information using this link
** IMS National Sales Perspectives: Retail and Non-Retail MAT February 2017