New Launch3 Feb 2026, 01:27 pm
NATCO Pharma Receives Tentative Approval for Erdafitinib Tablets, a Generic Version of Balversa®
AI Summary
NATCO Pharma Limited has announced that it has received tentative approval for Erdafitinib tablets, a generic version of Balversa®, from Janssen Biotech Inc. The approval is 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.
Key Highlights
- NATCO Pharma Limited receives tentative approval for Erdafitinib tablets, a generic version of Balversa®
- Erdafitinib tablets are 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