Natco Pharma Ltd Receives Tentative Approval for Erdafitinib Tables from U.S. FDA

Natco Pharma Limited has announced that it received tentative approval from the U.S. Food and Drug Administration (U.S. FDA) for Erdafitinib, 3 mg, 4mg, and 5 mg, a generic version of Balversa® by Janssen Biotech Inc. The drug 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.