Zydus Lifesciences Limited (including its subsidiaries and affiliates, collectively referred to as “Zydus”) has received final FDA approval 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).
As the name implies, Olmesartan Medoxomil and Hydrochlorothiazide is a combination of two medications: Olmesartan and Hydrochlorothiazide. Olmesartan is an ARB (angiotensin II receptor blocker), whereas hydrochlorothiazide is a diuretic (water pill). This combination medication is used to treat hypertension (hypertension). Lowering blood pressure may reduce the risk of having a stroke or heart attack. The drug will be produced at the group’s formulation manufacturing facility in Ahmedabad Special Economic Zone, India.
In the United States, 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 million (IQVIA MAT Dec. 2022).
Since the beginning of the filing process in FY 2003-04, the group has received 346 approvals and has filed over 440* ANDAs.