FDA Approves Aurobindo Hypertension Generic

The US Food and Drug Administration (FDA) has approved Aurobindo Pharma Limited’s generic version of olmesartan medoxomil and hydrochlorothiazide tablets in 20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg doses.

The tablets are indicated for treatment of hypertension to lower blood pressure, and have an estimated market size of $738.5 million for the twelve months ending February 2017.

The Division of Bioequivalence, has determined the drug to be bioequivalent and therapeutically equivalent to the reference listed drug Benicar HCT of Daiichi Sankyo, Inc.

The combined use of olmesartan medooxmil and hydrochlorothiazide was evaluated for safety in a clinical trial including 1243 hypertensive patients. Treatment with the combination drug was well tolerated, with an incidence of adverse events similar to that of a placebo. In the study, the most commonly reported adverse effects included nausea, hyperuricemia, dizziness, and upper respiratory infection, and occurred more often in the olmesartan medoxomil and hydrochlorothiazide combination than on the placebo.

The FDA previously granted the generic tentative approval in 2016 before its final approval.