HOME > MARKETS > COMPANY NEWS
  COMPANY NEWS
COMPANY
NATCO Pharma gets USFDA's tentative approval for Erdafitinib Tablets
Feb-03-2026

NATCO Pharma has received tentative approval from U.S. Food and Drug Administration (USFDA) for Erdafitinib, 3 mg, 4mg, and 5 mg, a generic version of Balversa by Janssen Biotech Inc. 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 around $60 million in the U.S. for 12 months ending September 2025 as per industry sales data.

Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.

  RELATED NEWS >>