ETON
ET-600/DESMODA (desmopressin oral solution)
FDA PDUFA Target Action Date · Eton Pharmaceuticals, Inc.
Wednesday, February 25, 2026
143 days ago
approved Drug Information
- Application Type
- NDA
- Indication
- Central diabetes insipidus (AVP deficiency) in pediatric patients
- Approved As
- DESMODA (desmopressin acetate oral solution)
Filing Details
- Company
- Eton Pharmaceuticals, Inc. →
- Stock Ticker
- ETON
- SEC CIK
- 0001710340
- Source
- Company IR →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
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Data sourced from SEC EDGAR filings. Last updated: 2026-03-22. Report an issue