Eton Pharmaceuticals’ NDA for ET-600 solution accepted by FDA

Eton Pharmaceuticals (ETON) announced the company’s New Drug Application, or NDA, for ET-600, a proprietary patented formulation of desmopressin oral solution, has been accepted for review by the FDA and has been assigned a Prescription Drug User Fee Act target action date of February 25, 2026. Eton’s team has already initiated commercial preparation activities in anticipation of a potential launch in Q1 2026. ET-600 is a proprietary formulation of desmopressin oral solution developed for the treatment of central diabetes insipidius, also known as arginine vasopressin deficiency. The company has been issued a patent for ET-600’s formulation that extends to 2044 and has an additional patent application under review by the USPTO. AVP-D is estimated to impact approximately 3,000 pediatric patients in the U.S.