regulatory
confidence high
sentiment positive
materiality 0.70
Eton submits NDA to FDA for ET-400 hydrocortisone oral solution; approval expected Q1 2025
Eton Pharmaceuticals, Inc.
- NDA submitted for ET-400, a proprietary patented hydrocortisone oral solution.
- Company expects 10-month FDA review; potential approval and launch in Q1 2025.
- Combined peak sales of ET-400 and Alkindi Sprinkle forecast to exceed $50M annually.
- ET-400 has patent protection through 2043; additional patent applications under review.