regulatory
confidence high
sentiment positive
materiality 0.70
Eton Pharmaceuticals FDA accepts NDA for ET-400 (hydrocortisone oral solution); PDUFA Feb 28, 2025
Eton Pharmaceuticals, Inc.
- 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.