The US Food and Drug Administration has given Zydus Lifesciences Ltd final approval to sell Valsartan Tablets 40 mg, 80 mg, 160 mg, and 320 mg dosages, which are used to treat hypertension. 

The US health regulator has granted final approval to all subsidiaries or affiliates of Zydus Lifesciences.

Valsartan tablets are indicated for treating hypertension to lower blood pressure in adults and paediatric patients aged one year and older.

These tablets are also indicated for treating heart failure in adults, helping the heart pump more efficiently, and improving survival rates after a heart attack.

The company said that valsartan tablets would be produced at Zydus Lifesciences’ formulation manufacturing facility in Ahmedabad SEZ – II, Gujarat.

According to May 2024 IQVIA MAT data, sales of Azilsartan Medoxomil Tablets in the US had reached $149.5 million annually.

Zydus Lifesciences filed more than 460 Abbreviated New Drug Applications (ANDA) and gained 400 approvals in total as of March 31, 2024. The filing procedure began back in FY 2003–04.

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