Corporate News     14-Jun-24
Zydus receives USFDA tentative approval for Azilsartan Medoxomil and Chlorthalidone Tablets

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) to market Azilsartan Medoxomil and Chlorthalidone Tablets, 40 mg/12.5 mg and 40 mg/25 mg (USRLD: Edarbyclor® tablets).

Azilsartan and chlorthalidone is an angiotensin II receptor blocker (ARB) and a thiazide like diuretic combination product indicated for the treatment of high blood pressure (hypertension), to lower blood pressure.

The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India.

Azilsartan Medoxomil and Chlorthalidone Tablets had annual sales of USD 77.9 mn in the United States (IQVIA MAT March 24).

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