Eton Pharmaceuticals Announces Submission of Prior Approval Supplement to Expand Indication of KHINDIVI® (hydrocortisone) Oral Solution

* FDA submission seeks to bring KHINDIVI to larger pediatric patient population within the adrenal insufficiency market * New formulation successfully demonstrated bioequivalence to ALKINDI SPRINKLE(®) * Submission allows for a potential first half 2027 approval of the expanded indication DEER PARK, Ill., July 29, 2026 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today 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 U.S. Food and Drug Administration (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.