Natco Pharma has received tentative approval for Erdafitinib tablets (3 mg, 4mg, and 5 mg), a generic version of Balversa®. The drug is indicated for treating adult patients with locally advanced or metastatic urothelial carcinoma. Estimated sales for Erdafitinib tablets reached USD 60 million in the U.S. for the 12 months ending Sep’25.
Erdafitinib Tablets Approval
Natco Pharma Limited announced it has received tentative approval for its Erdafitinib tablets, which are available in 3 mg, 4 mg, and 5 mg dosages. This is a generic version of Balversa®, originally produced by Janssen Biotech Inc.
Indication and Use
The approved drug, Erdafitinib, is indicated for the treatment of adult patients suffering from locally advanced unresectable or metastatic urothelial carcinoma. It is intended for patients harbouring susceptible FGFR3 genetic alterations with disease progression following at least one line of prior therapy.
Market Performance
According to industry sales data, Erdafitinib tablets had estimated sales of approximately USD 60 million in the U.S. for the 12-month period ending September 2025 (Q2).
Source: BSE
