Lupin, Concord, receive US FDA approval for Mycophenolate Mofetil tablets USP

Lupin, in alliance with Concord Biotech, announced that it has received approval from the United States Food and Drug Administration (US FDA) for Mycophenolate Mofetil tablets USP, 500 mg, to market a generic version of CellCept tablets of Roche Palo Alto (Roche).

Mycophenolate Mofetil Tablets are indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.

Mycophenolate Mofetil tablets USP, 500 mg had an annual sales of approximately $96 million in the US (IQVIA MAT Mar 2020).