Eton Pharmaceuticals files FDA supplement to expand Khindivi to under-5s

Eton Pharmaceuticals (Nasdaq: ETON) has submitted a Prior Approval Supplement to the U.S. Food and Drug Administration seeking to expand the approved indication of Khindivi (hydrocortisone) oral solution to include pediatric patients under five years of age.

Khindivi is currently approved for patients five years of age and older with adrenocortical insufficiency. The company said a new formulation of the product demonstrated bioequivalence to Alkindi Sprinkle (hydrocortisone) oral granules, the existing FDA-approved hydrocortisone granule formulation, which formed the basis for the supplemental filing.

The submission targets a potential FDA approval in the first half of 2027, according to the company.

"Today's submission represents an important milestone in our strategy to make Khindivi available to the broadest possible pediatric adrenal insufficiency population," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. "We know the largest need for an FDA-approved oral liquid hydrocortisone remains with children under age five."

Khindivi was originally approved in May 2025 as a replacement therapy for pediatric adrenocortical insufficiency. The product is described as a ready-to-use oral solution that does not require tablet manipulation and is compatible with gastric tube administration. Eton estimates there are approximately 10,000 pediatric adrenal insufficiency patients in the U.S.

Adrenocortical insufficiency is a condition in which the adrenal glands do not produce sufficient cortisol. The current Khindivi label notes the product is not approved for stress dosing during acute events.

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