Zydus Lifesciences bags USFDA tentative nod for Azilsartan Medoxomil and Chlorthalidone Tablets for hypertension
Ahmedabad: Zydus Lifesciences Limited has announced that the Company has received tentative approval from the United States Food and Drug Administration (USFDA) to market Azilsartan Medoxomil and Chlorthalidone Tablets, 40 mg/12.5 mg and 40 mg/25 mg (USRLD: Edarbyclor tablets).
Azilsartan and chlorthalidone is an angiotensin II receptor blocker (ARB) and a thiazide like diuretic combination product indicated for the treatment of high blood pressure (hypertension), to lower blood pressure.
Hypertension, or high blood pressure, is a condition where the force of blood against artery walls is consistently elevated. It's often symptomless but can lead to serious health issues like heart disease and stroke if untreated. Lifestyle changes and medications can help manage it.
The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ - II, India.
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Azilsartan Medoxomil and Chlorthalidone Tablets had annual sales of USD 77.9 mn in the United States (IQVIA MAT March 24). The group now has 397 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.
Headquartered in Ahmedabad, Zydus Lifesciences Limited is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer-related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs.
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