Lupin, in alliance with Concord Biotech, announced that it has received approval from the United States Food and Drug Administration (US FDA) for Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg, to market a generic version of Prograf Capsules, 0.5 mg, 1 mg, and 5 mg, of Astellas Pharma US.
Tacrolimus Capsules USP are indicated for the prophylaxis of organ rejection in adult and paediatric patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants.
Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg (RLD: Prograf) had an annual sales of approximately $303 million in the US (IQVIA MAT September 2020).