Aurobindo Receives FDA Approval for Telmisartan & Hydrochlorothiazide Tablets USP, 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25mg

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Telmisartan & Hydrochlorothiazide Tablets USP, 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Telmisartan & Hydrochlorothiazide Tablets USP, 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), Micardis® HCT Tablets, 40 mg/12.5 mg. 80 mg/12.5 mg and 80 mg/25 mg of Boehringer Ingelheim (BI).

Telmisartan & Hydrochlorothiazide Tablets USP, 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25mg is indicated for the treatment of Hypertension.

The product has an estimated market size of $81.9M for the twelve months ending November 2016 according to IMS*.
Telmisartan & Hydrochlorothiazide Tablets USP, 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25mg represents the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 252 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