Zydus gets tentative approval from USFDA for hypertension drugs

New Delhi: Indian drug maker Zydus Lifesciences on Friday announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for hypertension drugs to market in the US.

The company received the nod to market are Azilsartan Medoxomil and Chlorthalidone Tablets, 40 mg/12.5 mg and 40 mg/25 mg.

Azilsartan and chlorthalidone tablets are 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 maker explained.

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

According to the data by the global provider of advanced analytics, technology solutions IQVIA, Azilsartan Medoxomil and Chlorthalidone Tablets had annual sales of $77.9 mn in the US.

The group now has 397 approvals and has so far filed more than 460 ANDAs (as of March 31, 2024) since the commencement of the filing process in FY 2003-04.

Last month, Zydus received final approval from USFDA to market Theophylline Extended-Release tablets to treat asthma.

The company said that the US regulator approved the sale of the Theophylline tablets of dosages 300 mg and 450 mg.