Core Points - Eton Pharmaceuticals announced that the FDA has extended the PDUFA goal date for the NDA of ET-400 to May 28, 2025, due to the need for additional review time [1][2] - The FDA applied a standard three-month extension from the original goal date of February 28, 2025, following the submission of supplemental information in December [2] - Eton's CEO expressed confidence in the NDA package and does not expect the extension to significantly impact the company's 2025 revenue projections [3] Company Overview - Eton Pharmaceuticals focuses on developing and commercializing treatments for rare diseases, currently offering seven commercial products [4] - The company has four additional product candidates in late-stage development, including ET-400, ET-600, Amglidia®, and ZENEO® hydrocortisone autoinjector [4]
Eton Pharmaceuticals Announces Extension of PDUFA Goal Date for ET-400