Eton Pharmaceuticals submits NDA for ET-600 (desmopressin oral solution) for central diabetes insipidus

Eton Pharmaceuticals, Inc.

FDA NDA submission for ET-600, a proprietary oral solution of desmopressin for central diabetes insipidus.
Expected 10-month FDA review; potential approval and launch in Q1 2026.
Patent expires in 2044; bioequivalence study in 75 subjects demonstrated PK equivalence to reference product.
Estimated 3,000 pediatric patients in the U.S. with central diabetes insipidus.
Pre-launch commercial activities underway; CEO cites strong physician demand for titratable pediatric dosing.

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