Zydus Lifesciences Gets USFDA Nod for Generic Azilsartan Medoxomil

Zydus Lifesciences has received tentative approval from the USFDA to market its generic Azilsartan Medoxomil tablets, used for treating high blood pressure. The drug, manufactured in Ahmedabad, can be prescribed alone or with other antihypertensive agents. Annual US sales for the drug were USD 89 million.

Zydus Lifesciences announced on Thursday that it has obtained tentative approval from the US Food and Drug Administration (USFDA) for marketing its generic Azilsartan Medoxomil tablets, which are utilized in treating high blood pressure.

The approval covers Azilsartan Medoxomil tablets in strengths of 40 mg and 80 mg, as stated in a regulatory filing by the company. The manufacturing of the drug will take place at the group's formulation facility located in Ahmedabad SEZ - II.

This medication is indicated for hypertension treatment, significantly lowering blood pressure and reducing risks of fatal and nonfatal cardiovascular events such as strokes and myocardial infarctions. Zydus Lifesciences mentioned that the drug could be used alone or in combination with other antihypertensive agents. According to IQVIA March 2024 data, annual sales for the drug in the US reached USD 89 million.

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