USFDAJul 29, 2026, 06:52 AM
Eton Pharma seeks FDA approval for KHINDIVI in younger pediatric patients
AI Summary
Eton Pharmaceuticals announced the submission of a Prior Approval Supplement (PAS) to the U.S. FDA for KHINDIVI (hydrocortisone) oral solution. The submission aims to expand the product's label to include younger pediatric patients, specifically those under five years of age, for adrenocortical insufficiency. A new formulation of KHINDIVI successfully demonstrated bioequivalence to ALKINDI SPRINKLE®, and the company anticipates potential FDA approval for this expanded indication in the first half of 2027.
Key Highlights
- Eton Pharma submitted a Prior Approval Supplement (PAS) to the FDA for KHINDIVI.
- Submission seeks to expand KHINDIVI's label to include pediatric patients under 5 years.
- New KHINDIVI formulation demonstrated bioequivalence to ALKINDI SPRINKLE®.
- KHINDIVI is currently approved for pediatric patients aged 5 years and above.
- Potential FDA approval for the expanded indication is anticipated in H1 2027.
- KHINDIVI is the only FDA-approved oral solution of hydrocortisone.
- Eton estimates approximately 10,000 pediatric adrenal insufficiency patients in the U.S.
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