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Eton Pharma Submits NDA To FDA For Proprietary Desmopressin Oral Solution ET-600; Anticipates Q1 2026 Launch After 10-month Review

Benzinga·04/28/2025 10:53:41
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- NDA submitted for the treatment of central diabetes insipidus -

- Expected 10-month review; commercial preparations underway for a potential Q1 2026 launch –

DEER PARK, Ill., April 28, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc ("Eton" or the "Company") (NASDAQ:ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ET-600, Eton's proprietary, patented oral solution of desmopressin under development for the treatment of central diabetes insipidus. The Company expects the application to be assigned a 10-month FDA review, allowing for potential approval and launch in the first quarter of 2026.