Lupin alliance partner Concord gets USFDA nod for generic medicine

Concord has received approval from the US Food and Drug Administration (USFDA) to market the drug to prevent organ transplant rejection

Drugmaker Lupin on Thursday said its partner Concord Biotech has received approval from the US health regulator to market Mycophenolate Mofetil tablets, used to prevent organ transplant rejection.

Concord has received approval from the US Food and Drug Administration (USFDA) to market the product, which is a generic version of Roche Palo Alto's CellCept tablets, Lupin Ltd said in a statement.

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, it added.

As per IQVIA MAT March 2020 data, Mycophenolate Mofetil Tablets USP, 500 mg had annual sales of around $96 million in the US.