FDA approves Aurobindo’s hypertension generics

EAST WINDSOR, N.J. — Aurobindo Pharma 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, Benicar HCT of Daiichi Sankyo.

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. 

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.