USFDA gives tentative approval to Zydus’ blood pressure lowering drug


Indian drug maker Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for hypertension drugs to market in the US, the company said Friday, June 14.

The company received the tentative nod to market Azilsartan Medoxomil and Chlorthalidone Tablets of strengths 40 mg/12.5 mg and 40 mg/25 mg, the company said in a regulatory filing.

Azilsartan and chlorthalidone tablets are 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.

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