New Delhi, Zydus Lifesciences On Thursday it said it has received provisional approval from the US health regulator to market its generic drug. Azilsartan Medoxomil Tablet used for treatment high blood pressure.Temporary approval by the court U.S. Food and Drug Administration ,USFDA) is for azilsartan medoxomil tablets with strengths of 40 mg and 80 mg, Zydus Lifesciences said in a regulatory filing.
He said the drug will be manufactured at the group’s formulation manufacturing unit located at Ahmedabad SEZ-II.
Azilsartan is indicated for the treatment of: high blood pressure It said the drug is effective in lowering blood pressure and reducing the risk of fatal and non-fatal cardiovascular events, primarily stroke and myocardial infarction.
The company said the drug can be used alone or in combination with other antihypertensive agents.
The company cited March 2024 data from IQVIA, saying its annual sales in the US were US$89 million.
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