Zydus Lifesciences gets USFDA’s tentative approval for Azilsartan Medoxomil Tablets

04 Jul 2024 Evaluate

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) to market Azilsartan Medoxomil Tablets, 40 mg and 80 mg (USRLD: Edarbi tablets).

Azilsartan is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Azilsartan medoxomil tablets may be used either alone or in combination with other antihypertensive agents. The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ - II, India.

Azilsartan Medoxomil Tablets had annual sales of $89 million in the United States (IQVIA MAT March 24). The group now has 398 approvals and has so far filed over 460 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.


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