---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-24-022736"
form_type: "8-K"
ticker: "ETON"
cik: "0001710340"
company_name: "Eton Pharmaceuticals, Inc."
filed_at: "2024-07-15T23:59:59+00:00"
generated_at: "2026-05-31T20:43:13.238732+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Eton Pharmaceuticals FDA accepts NDA for ET-400 (hydrocortisone oral solution); PDUFA Feb 28, 2025

## Summary
- PDUFA target action date set for February 28, 2025.
- ET-400 is a proprietary room-temperature stable hydrocortisone oral solution with patent protection through 2043.
- CEO Sean Brynjelsen projects combined peak sales of ET-400 and ALKINDI SPRINKLE to exceed $50 million annually.
- Company preparing for potential product launch in early 2025 upon FDA approval.

## SEC filing metadata
- accession: 0001437749-24-022736
- form_type: 8-K
- ticker: ETON
- cik: 0001710340
- company_name: Eton Pharmaceuticals, Inc.
- filed_at: 2024-07-15T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1710340/000143774924022736/0001437749-24-022736-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1710340/000143774924022736/eton20240708_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-24-022736
- JSON: https://secwatch.observer/filing/0001437749-24-022736.json
- Plain text: https://secwatch.observer/filing/0001437749-24-022736.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.