TheraRadar
ETON

Eton Pharmaceuticals, Inc.

FDA PDUFA Target Action Date

Wednesday, February 25, 2026
90 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

Stock Ticker
ETON
SEC CIK
0001710340

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