Natco Pharma gets U.S. FDA tentative nod for generic of Janssen’s cancer drug

Natco Pharma has received U.S. Food and Drug Administration’s tentative approval for Erdafitinib Tablets 3 mg, 4mg, and 5 mg, a generic version of Janssen Biotech cancer drug Balversa.

Erdafitinib tablets had estimated sales of $60 million in the U.S. for 12 months ending September 2025, it said on Tuesday, citing industry sales data. The company’s shares closed 3.63% higher at ₹853.40 each on the BSE.

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 one line of prior therapy.