FDA Extends PDUFA Date for Eton Pharmaceuticals’ ET-400

Eton Pharmaceuticals has announced that the U.S. FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for its New Drug Application (NDA) for ET-400, a treatment for pediatric rare diseases. Originally set for February 28, 2025, the new decision date is now May 28, 2025, allowing the FDA additional time to review supplemental information submitted in December.

Despite the extension, Eton remains optimistic about approval and its commercial launch this year. CEO Sean Brynjelsen reassured stakeholders that the company has fully addressed the FDA’s inquiries and expects no major impact on its 2025 revenue forecasts. The decision marks a key step in ensuring regulatory clarity and timely patient access to this critical therapy.