Zydus receives final approval from the USFDA for Olmesartan Medoxomil and Hydrochlorothiazide Tablets

Zydus receives final approval from the USFDA for Olmesartan Medoxomil and Hydrochlorothiazide Tablets Ahmedabad, India, 28 February, 2023 Zydus Lifesciences Limited (including its subsidiaries/affiliates hereafter referred to as “Zydus”) 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 suggest s 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. (*as of 31st December 2022) ***

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