regulatory
confidence high
sentiment positive
materiality 0.80
Eton Pharma gets FDA approval for KHINDIVI oral solution; peak sales >$50M
Eton Pharmaceuticals, Inc.
- KHINDIVI is the first and only FDA-approved hydrocortisone oral solution for pediatric adrenocortical insufficiency.
- Commercial launch expected week of June 2, 2025; product distributed through Anovo specialty pharmacy.
- Combined peak sales of KHINDIVI and ALKINDI SPRINKLE expected to exceed $50 million per year.
- Indicated for patients 5 years and older; eliminates need to split or crush tablets for accurate dosing.
- Eton's rare disease sales team to promote alongside ALKINDI SPRINKLE; Eton Cares program offers $0 co-pay for qualifying patients.
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