Eton Pharmaceuticals Announces Submission of NDA for ET-600 (Desmopressin Oral Solution)
Core Points - Eton Pharmaceuticals has submitted a New Drug Application (NDA) for ET-600, an oral solution of desmopressin for treating central diabetes insipidus, with a 10-month FDA review expected and a potential launch in Q1 2026 [1][2] - If approved, ET-600 will be the only FDA-approved oral liquid formulation of desmopressin, addressing the needs of approximately 3,000 pediatric patients in the U.S. [2] - Eton holds a patent for ET-600 that expires in 2044, with additional patent applications under review [2] - The company has seven commercial rare disease products and six additional product candidates in late-stage development [3]