Natco Pharma Receives USFDA Approval for Generic Erdafitinib

Natco Pharma has received tentative approval from the US Food and Drug Administration (USFDA) for its generic version of Erdafitinib, a drug used in the treatment of advanced urothelial carcinoma.

The approval covers Erdafitinib in 3 mg, 4 mg, and 5 mg strengths, which is the generic equivalent of Janssen Biotech’s Balversa.

Erdafitinib is indicated for adult patients with locally advanced or metastatic urothelial carcinoma who harbor susceptible FGFR3 genetic alterations and have experienced disease progression after at least one line of prior therapy.

This approval marks a significant step for Natco Pharma in expanding its oncology portfolio and enhancing access to affordable cancer treatments.

As per industry sales data, the original Erdafitinib tablets had estimated sales of approximately USD 60 million in the U.S. for the 12 months ending September 2025. This positions Natco’s generic version to tap into a substantial market, offering a more cost-effective option for patients battling this aggressive form of cancer.

The approval not only strengthens Natco Pharma’s presence in the U.S. market but also highlights the growing demand for generic oncology treatments. This move aligns with the company’s ongoing commitment to providing high-quality, affordable therapies for critical medical conditions.