Biocon unit gets USFDA nod for generic drug

Biotechnology firm Biocon said its subsidiary has received approval from the US health regulator to market a generic medication to treat chronic heart failure. Biocon Pharma has received approval of its ANDA for Sacubitril/Valsartan Tablets, in 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg strengths, from the US Food and Drug Administration (USFDA), the company 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 medicine is also used to treat paediatric patients over the age of one year.


The approval further adds to Biocon's portfolio of vertically integrated, complex drug products, the company said.