Eton Pharma: FDA accepts NDA for ET-600 desmopressin oral solution; PDUFA Feb 25, 2026

Eton Pharmaceuticals, Inc.

FDA accepted NDA for ET-600 (desmopressin oral solution) with PDUFA target action date of February 25, 2026.
Product has patent protection through 2044; expected to be first oral liquid option for pediatric desmopressin dosing.
CEO states commercial preparation activities already underway for potential launch in Q1 2026.
Caregivers currently must cut tablets or use unapproved compounding pharmacy liquids for pediatric dosing.

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