Natco Pharma Receives Tentative FDA Approval for Erdafitinib

Natco Pharma Limited has announced that it received tentative approval from the U.S. FDA for its generic version of Erdafitinib tablets. The approval covers tablet strengths of 3 mg, 4 mg, and 5 mg. Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma that harbors susceptible FGFR3 genetic alterations. This approval is significant for patients who have experienced disease progression during at least one line of prior therapy.

The original branded product, Balversa, is manufactured by Janssen Biotech Inc. According to industry sales data, Balversa had estimated sales of approximately USD 60 million in the United States for the 12 months ending September 2025. The tentative approval allows Natco Pharma to market its generic version in the U.S. upon final approval and patent expiry of the branded product.

Natco Pharma is involved in the development, manufacturing, and distribution of generic and branded pharmaceuticals, including specialty pharmaceuticals and active pharmaceutical ingredients. The company focuses on oncology and targeted therapies in the domestic market and aims to introduce limited competition molecules in the U.S. market. Natco operates nine manufacturing sites and two research and development facilities in India, with approvals from several leading regulatory authorities, including the U.S. FDA, Brazil ANVISA, and Health Canada.

Natco Pharma Limited is a research and development-oriented company, emphasizing science-driven approaches in its operations. It is a leading player in oncology and targeted therapies within the domestic market. The company is committed to expanding its presence in the U.S. market by focusing on limited competition molecules, leveraging its manufacturing and R&D capabilities to cater to over 50 global markets.