08:30 AM EDT, 04/28/2025 (MT Newswires) -- Eton Pharmaceuticals ( ETON ) said Monday it submitted a new drug application to the US Food and Drug Administration for ET-600, its proprietary oral solution of desmopressin developed to treat central diabetes insipidus.
The company said it expects a standard 10-month review, potentially leading to approval and launch in Q1 2026.
ET-600 is protected by a US patent valid through 2044, with additional patents pending, Eton said.
Shares were 0.5% higher in recent premarket activity.