Natco Pharma has received tentative approval from the U.S. FDA for its Erdafitinib tablets, which are a generic version of Balversa®. These tablets, available in 3 mg, 4mg, and 5 mg strengths, are indicated for treating adult patients with locally advanced or metastatic urothelial carcinoma with specific genetic alterations. The market size for Erdafitinib tablets was approximately USD 60 million for the 12 months ending September 2025.
Tentative FDA Approval Received
Natco Pharma has been granted tentative approval by the U.S. Food and Drug Administration (FDA) to manufacture and market its generic Erdafitinib tablets. This announcement was officially released on February 3, 2026.
Generic Version of Balversa®
The approved drug, Erdafitinib, is a generic version of Balversa®, originally developed by Janssen Biotech Inc. The medication will be available in 3 mg, 4 mg, and 5 mg dosages.
Therapeutic Use
Erdafitinib tablets are specifically designed for adult patients suffering from locally advanced unresectable or metastatic urothelial carcinoma. This treatment is intended for patients who possess susceptible FGFR3 genetic alterations and have experienced disease progression after at least one prior line of therapy.
Market Data
According to industry sales data, Erdafitinib tablets achieved estimated sales of approximately USD 60 million in the U.S. market for the 12-month period ending September 2025. This figure highlights the potential market impact of Natco Pharma’s generic version.
Source: BSE
