Biocon Subsidiary Gains USFDA Nod for Heart Failure Medication

Biocon's subsidiary, Biocon Pharma, has received approval from the US Food and Drug Administration (USFDA) to market a generic version of Sacubitril/Valsartan tablets. This medication addresses chronic heart failure in adults and children over one, adding to Biocon's portfolio of complex drug products.

Biotechnology firm Biocon has announced that its subsidiary, Biocon Pharma, has received approval from the US health regulator to market a generic medication designed to treat chronic heart failure.

Biocon Pharma was granted approval for its Abbreviated New Drug Application (ANDA) for Sacubitril/Valsartan Tablets in varying strengths of 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg by the US Food and Drug Administration (USFDA), according to an official regulatory filing.

Sacubitril/Valsartan is prescribed for chronic heart failure treatment in adults to lower the risk of death and hospitalisation and is also indicated for pediatric patients older than one year.

This latest approval enhances Biocon's portfolio of vertically integrated, complex drug products, adding another feather to the firm's cap.

(With inputs from agencies.)