Zydus gets tentative nod from USFDA for blood pressure lowering drug

Zydus Lifesciences Ltd on Friday said it has received tentative approval from the US health regulator to market Azilsartan Medoxomil and Chlorthalidone tablets, which are indicated for the treatment of high blood pressure.

The tentative approval by the US Food and Drug Administration (USFDA) is for Azilsartan Medoxomil and Chlorthalidone tablets of strengths 40 mg/12.5 mg and 40 mg/25 mg, Zydus Lifesciences said in a regulatory filing.

Azilsartan and Chlorthalidone are diuretic combination products indicated for the treatment of high blood pressure to lower blood pressure, it added.

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

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