Zydus Life gets USFDA approval to market heart failure treatment drug
Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to market its generic Sacubitril and Valsartan tablets combination used to treat chronic heart failure in adults.
The approval by the US Food and Drug Administration (USFDA) is to market Sacubitril and Valsartan tablets of strengths 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, Zydus Lifesciences said in a regulatory filing.
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, the company added.