Zydus Lifesciences Hypertension drug gets USFDA okay

Ahmedabad: Zydus Lifesciences Limited has announced that the company has received final approval from the United States Food and Drug Administration (USFDA) for Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg (USRLD: Benicar HCT Tablets).

Olmesartan Medoxomil and Hydrochlorothiazide, as the name suggests is a combination of two medicines: Olmesartan and Hydrochlorothiazide. Olmesartan is an angiotensin II receptor blocker (sometimes called an ARB blocker) while hydrochlorothiazide is a diuretic (water pill). This combination medicine is used to treat high blood pressure (hypertension). Lowering blood pressure may lower risk of a stroke or heart attack.

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.

Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg had annual sales of USD 41.7 mn in the United States (IQVIA MAT Dec. 2022). The group now has 346 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.

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