Zydus Lifesciences Gains US Approval for Heart Failure Drug

Zydus Lifesciences has received final approval from the US FDA to market its generic Sacubitril and Valsartan tablets for treating chronic heart failure in adults. The drug aims to reduce the risk of death and hospitalization and will be manufactured in Moraiya, Ahmedabad.

Zydus Lifesciences Ltd announced on Wednesday that it has secured final approval from the US Food and Drug Administration (USFDA) to market its generic version of Sacubitril and Valsartan tablets. These medications are designed to treat chronic heart failure in adults.

The approved strengths for the Sacubitril and Valsartan tablets are 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, as stated in a regulatory filing by the company.

This pharmaceutical combination is specifically used to manage chronic heart failure, thereby reducing the risk of death and hospitalization. Production of the drug will take place at the group's formulation manufacturing facility in Moraiya, Ahmedabad, according to the company.

(With inputs from agencies.)