Zydus Lifesciences Hypertension drug gets USFDA okay
The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.
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.
Zydus Lifesciences Limited (Formerly known as Cadila Healthcare Limited), an Indian Pharmaceutical company is a fully integrated, global healthcare provider. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals.
