NATCO receives FDA's tentative approval for Erdafitinib tablets

NATCO’s Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma harbouring susceptible FGFR3 genetic alteration

NATCO Pharma Limited received tentative approval for Erdafitinib, 3 mg, 4mg, and 5 mg, a generic version of Balversa by Janssen Biotech.

NATCO’s Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma harbouring susceptible FGFR3 genetic alterations who have disease progression during at least 1 line of prior therapy.

Erdafitinib tablets had estimated sales of approximately USD 60 million in the U.S. for 12 months ending Sep’25 as per industry sales data.