Eton Pharmaceuticals submitted a Prior Approval Supplement to the FDA on July 29, 2026, seeking to expand the approved indication for KHINDIVI (hydrocortisone) oral solution to include younger pediatric patients. The submission is based on data demonstrating that the new formulation achieved bioequivalence with ALKINDI SPRINKLE. Currently approved for children aged five and older, expanding the label aims to address the significant unmet need in the under-five demographic within the adrenal insufficiency market. Eton anticipates a potential approval decision in the first half of 2027. This regulatory development could broaden the product's commercial addressable population and accelerate adoption rates for this rare disease therapy.