Aurobindo Receives FDA Approval for Olmesartan Medoxomil and Hydrochlorothiazide Tablets

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), BENICAR HCT® of Daiichi Sankyo, Inc.

Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg is indicated for the treatment of hypertension*.

The product has an estimated market size of $738.5M for the twelve months ending February 2017, according to IMS**.

Olmesartan Medoxomil and Hydrochlorothiazide Tablets 20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg mg/ represents the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 260 final approvals, including 37 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