Zydus Lifesciences Ltd announced on Friday that it has received tentative approval from the US Food and Drug Administration (USFDA) to market Azilsartan Medoxomil and Chlorthalidone tablets. These tablets are intended for the treatment of high blood pressure.
According to a regulatory filing by Zydus Lifesciences, the tentative approval covers Azilsartan Medoxomil and Chlorthalidone tablets in strengths of 40 mg/12.5 mg and 40 mg/25 mg. This combination product of Azilsartan and Chlorthalidone acts as a diuretic to lower blood pressure.
The manufacturing of the drug will take place at Zydus Lifesciences’ formulation manufacturing facility located in Ahmedabad SEZ-II, India.
Based on IQVIA MAT March 2024 data, Zydus Lifesciences noted that Azilsartan Medoxomil and Chlorthalidone tablets achieved annual sales of USD 77.9 million in the US.
