Eton Pharmaceuticals: FDA extends PDUFA date for NDA for ET-400 to 5/28

Eton Pharmaceuticals (ETON) announced that the U.S. FDA has extended the Prescription Drug User Fee Act goal date for the New Drug Application for ET-400. The new PDUFA goal date is May 28. The company was notified that the FDA requires additional time to conduct a full review of supplemental information that was provided in December in response to an FDA request. The FDA communicated that it has applied a standard three-month extension from the original goal date of February 28. Eton believes it has fully addressed all questions from the FDA and there are no outstanding requests. “We are confident in the strength of our NDA package and look forward to ensuring access to patients in need of this important pediatric rare disease therapy immediately after FDA approval this year. We do not expect this standard extension to significantly affect our internal 2025 revenue projections,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.