Ahmedabad: Zydus Lifesciences Limited has received tentative approval from the US Food and Drug Administration (US FDA) 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 $77.9 million in the US (IQVIA MAT March 24).
