NATCO Pharma received tentative approval from the USFDA for Erdafitinib, 3 mg, 4mg, and 5 mg, a generic version of Balversa® by Janssen Biotech Inc. </P> 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. </P> 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.</P>