Zydus gains final FDA nod for Sacubitril and Valsartan Tablets

Zydus Lifesciences has received final approval from the United States Food and Drug Administration 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 hospitalisation. The drug will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad.

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 (as of March 2024) since the commencement of the filing process in FY 2003-04.