Generic Hypertension Drug Gains FDA Approval

The FDA has approved Aurobindo Pharma’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 reference listed drug, Daiichi Sankyo’s Benicar HCT tablets are indicated to treat hypertension to lower blood pressure.

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.

Reference

Aurobindo receives FDA approval for olmesartan medoxomil and hydrochlorothiazide Tablets [press release]. East Windsor, N.J. Aurobindo Pharma Limited. Accessed May 1, 2017.