Core Insights - Eton Pharmaceuticals has received FDA acceptance for its New Drug Application (NDA) for ET-600, with a target action date set for February 25, 2026 [1] - ET-600 is a patented formulation of desmopressin oral solution, protected until 2044, aimed at treating central diabetes insipidus in pediatric patients [1][3] - The company is preparing for a potential product launch in the first quarter of 2026, addressing a significant unmet need in pediatric endocrinology [2] Company Overview - Eton Pharmaceuticals focuses on developing and commercializing treatments for rare diseases, currently offering eight commercial products [4] - The company has five additional product candidates in late-stage development, including ET-600, Amglidia®, ET-700, ET-800, and ZENEO® hydrocortisone autoinjector [4] - ET-600 is expected to be the only oral liquid option available for pediatric patients requiring precise dosing, as current alternatives involve cutting tablets or using unapproved suspensions [2][3]
Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-600 (Desmopressin Oral Solution)