Eton Submits FDA Supplement to Expand KHINDIVI Use to Pediatric Patients Under 5 Years – Eton Pharmaceuticals

Eton Pharmaceuticals, Inc announced that the Company’s new formulation of Khindivi (hydrocortisone) oral solution successfully showed bioequivalence to Alkindi Sprinkle (hydrocortisone) oral granules, the FDA-approved hydrocortisone granule formulation, and the Company has submitted a Prior Approval Supplement (PAS) to the FDA requesting an expansion of the product’s label to include younger pediatric patients.
Khindivi is currently approved for patients ages five years and above.

“Today’s submission represents an important milestone in our strategy to make Khindivi available to the broadest possible pediatric adrenal insufficiency population. We know the largest need for an FDA-approved oral liquid hydrocortisone remains with children under age five, so we are excited to fill this gap. Our new formulation was designed with young children in mind and now that we have submitted a PAS application demonstrating bioequivalence, we are one step closer to potentially expanding the label in the first half of 2027. We believe broadening the approved age range will drastically accelerate adoption of the product.” – Sean Brynjelsen, CEO of Eton Pharmaceuticals.

Khindivi is the only FDA-approved oral solution of hydrocortisone and was approved in May 2025 as a replacement therapy in pediatric patients five years of age and older with adrenocortical insufficiency. The product was designed to offer precise, ready-to-use dosing without the need for tablet manipulation or relying on non-FDA approved compounded liquid suspensions, providing a therapy option for patients who have difficulty swallowing tablets or those with special administration needs, such as a gastric tube.

Adrenocortical insufficiency is a rare, but serious condition in which the adrenal glands do not produce sufficient cortisol. Eton estimates that there are approximately 10,000 pediatric adrenal insufficiency patients in the U.S.