New Delhi, Zydus Lifesciences on Thursday said it has received provisional approval from the US health regulator to market generic azilsartan medoxomil tablets, used to treat high blood pressure.
The provisional approval by the US Food and Drug Administration (USFDA) is for azilsartan medoxomil tablets in strengths of 40 mg and 80 mg, Zydus Lifesciences said in a regulatory filing.
It added that the drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ-II.
It states that azilsartan is indicated for the treatment of hypertension to lower blood pressure and reduce the risk of fatal and non-fatal cardiovascular events, primarily stroke and myocardial infarction.
The drug can be used alone or with other antihypertensive agents, the company said.
The company cited IQVIA March 2024 data as saying its annual sales in the US were US$89 million.
The provisional approval by the US Food and Drug Administration (USFDA) is for azilsartan medoxomil tablets in strengths of 40 mg and 80 mg, Zydus Lifesciences said in a regulatory filing.
It added that the drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ-II.
It states that azilsartan is indicated for the treatment of hypertension to lower blood pressure and reduce the risk of fatal and non-fatal cardiovascular events, primarily stroke and myocardial infarction.
The drug can be used alone or with other antihypertensive agents, the company said.
The company cited IQVIA March 2024 data as saying its annual sales in the US were US$89 million.
