Zydus Lifesciences Receives Tentative Approval for Azilsartan Medoxomil and Chlorthalidone Tablets from USFDA

Zydus Lifesciences Ltd. has announced that it has received tentative approval from the USFDA to market Azilsartan Medoxomil and Chlorthalidone Tablets, 40 mg/12.5 mg and 40 mg/25 mg. The drug is indicated for the treatment of high blood pressure and will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ - II, India. The drug had annual sales of USD 77.9 mn in the United States (IQVIA MAT March 24). Zydus now has 397 approvals and has filed over 460 ANDAs since the commencement of the filing process in FY 2003-04.