Eton Pharmaceuticals Seeks FDA Approval to Expand KHINDIVI Use in Younger Children
Thursday, July 30, 2026
Eton Pharmaceuticals has submitted a Prior Approval Supplement (PAS) to the US Food and Drug Administration (FDA) seeking to expand the approved use of KHINDIVI (hydrocortisone) oral solution to include younger paediatric patients. The application follows the successful demonstration of bioequivalence between a new formulation of KHINDIVI and ALKINDI SPRINKLE, the FDA-approved hydrocortisone oral granule product. KHINDIVI is currently approved for children aged five years and older.
The proposed expanded indication aims to address the treatment needs of children under the age of five, where demand for an FDA-approved oral liquid hydrocortisone therapy remains high. If approved, the updated label is expected in the first half of 2027.
KHINDIVI is the only FDA-approved hydrocortisone oral solution. It received FDA approval in May 2025 as replacement therapy for paediatric patients aged five years and above with adrenocortical insufficiency. The ready-to-use oral solution provides accurate dosing without the need to crush tablets or use compounded liquid preparations. It is also suitable for patients who have difficulty swallowing tablets or require administration through a gastric tube.
Adrenocortical insufficiency is a rare but serious condition in which the adrenal glands do not produce enough cortisol. Eton Pharmaceuticals estimates that around 10,000 paediatric patients in the United States are affected by the condition.
Source: globenewswire.com
