USFDA nod to Zydus Lifesciences chronic heart failure drug
Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration
(USFDA) to market Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97
mg/103 mg (USRLD: Entresto tablets).
Sacubitril and Valsartan combination is used to treat chronic heart failure in adults to help
reduce the risk of death and hospitalization.
Chronic heart failure is a condition where the heart muscle becomes weakened and cannot pump blood effectively. This leads to symptoms such as shortness of breath, fatigue, swelling, and reduced exercise tolerance. Common causes include coronary artery disease, high blood pressure, and previous heart attacks.The drug will be manufactured at the group’s
formulation manufacturing facility in Moraiya, Ahmedabad (India).
Sacubitril and Valsartan tablets had annual sales of USD 5,483 mn in the United States (IQVIA
MAT May 2024).
The group now has 399 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.
