Zydus Lifesciences Gets Tentative Approval From US FDA For New Drug

Zydus Lifesciences Ltd. announced that it has received tentative approval from the US Food and Drug Administration to market its Azilsartan Medoxomil and Chlorthalidone tablets, which are prescribed for the treatment of high blood pressure, according to an exchange filing on Friday.

The tentative approval covers Azilsartan Medoxomil and Chlorthalidone tablets in strengths of 40 mg/12.5 mg and 40 mg/25 mg. These tablets combine Azilsartan and Chlorthalidone, which work as a diuretic combination to effectively lower blood pressure.

The company added that the drug will be produced at its formulation manufacturing facility located in Ahmedabad SEZ-II, India.

Azilsartan Medoxomil and Chlorthalidone tablets had annual sales of $77.9 million in the US, Zydus Lifesciences said citing IQVIA MAT March 2024 data.

Zydus Lifesciences Ltd.'s consolidated net profit increased 3.9 times in the fourth quarter of fiscal 2024, and surpassed analysts' estimates. The company posted a net profit of Rs 1,182 crore in the quarter-ended March, in comparison with Rs 297 crore in the year-ago period, according to an exchange filing on May 17.

(With inputs from PTI)