Natco Pharma Receives Tentative US FDA Approval for Erdafitinib Tablets
Natco Pharma received tentative U.S. FDA approval for Erdafitinib tablets (generic of Balversa®). The drug is for advanced urothelial carcinoma. Erdafitinib had U.S. sales of approximately USD 60 million for the 12 months ending Sep '25.
The approval of a generic version of a drug with significant market sales suggests a medium impact on Natco Pharma's revenue and market position in the U.S. oncology segment.
The tentative approval from the U.S. FDA for a generic drug is a positive development for Natco Pharma, indicating potential market entry and revenue generation.
Natco Pharma Limited has received tentative approval from the U.S. FDA for its generic version of Erdafitinib tablets, with strengths of 3 mg, 4 mg, and 5 mg. This drug is a generic version of Balversa®, originally developed by Janssen Biotech Inc.
Erdafitinib is indicated for the treatment of adult patients diagnosed with locally advanced unresectable or metastatic urothelial carcinoma that harbors susceptible FGFR3 genetic alterations. It is prescribed for patients who have experienced disease progression after at least one line of prior therapy.
Industry sales data indicates that Erdafitinib tablets had estimated sales of approximately USD 60 million in the U.S. for the 12 months ending September 2025. Natco Pharma Limited, headquartered in Hyderabad, India, is an R&D-driven pharmaceutical company with a strong focus on oncology and limited competition molecules in the U.S. market. The company operates nine manufacturing sites and two R&D facilities in India, with its facilities approved by major regulatory authorities worldwide.
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