Lupin, Concord earn FDA nod for generic Prograf

Adult and pediatric patients receiving certain transplants will soon have a generic treatment available.

Lupin, in alliance with Concord Biotech, has passed muster with the Food and Drug Administration for tacrolimus capsules in dosage strengths of 0.5 mg, 1 mg, and 5 mg.

The medication is a generic of Astellas Pharma’s Prograf.

It is indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants.

Tacrolimus capsules had a market value of roughly $303 million, according to IQVIA September 2020 data.