Indian drugmaker Natco Pharma has received tentative approval from the United States Food and Drug Administration (USFDA) for its generic version of a cancer treatment drug, positioning the company for entry into the U.S. oncology market.
The regulatory nod covers the abbreviated new drug application (ANDA) for Erdafitinib tablets in 3 mg, 4 mg and 5 mg strengths, a generic equivalent of Janssen Biotech’s Balversa, used to treat adult patients with locally advanced unresectable or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations.
The approval makes Natco eligible to market the product in the United States, subject to final compliance with regulatory requirements. Industry data indicate that the branded Balversa had estimated U.S. sales of around USD 60 million for the 12 months ending September 2025, suggesting a significant market opportunity for the generic version once launched.
The regulatory filing also notes that Natco’s shares responded positively to the news, reflecting investor optimism about the company’s expanding footprint in the U.S. generics arena. Under U.S. law, tentative approvals allow companies to secure marketing authorisation ahead of patent expiries or additional regulatory milestones, enabling earlier access to high-value markets.
Natco Pharma’s latest approval adds to a growing portfolio of USFDA-cleared products in oncology and other therapeutic areas, reinforcing its strategy of focusing on regulated markets. The company’s existing approvals and filings with the U.S. health regulator underscore an ongoing effort to diversify its global revenue base by leveraging its development capabilities and regulatory expertise.
