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

ETON
  • Eton Pharmaceuticals submitted a Prior Approval Supplement to the FDA to expand KHINDIVI approval to pediatric patients under five years of age.
  • The new formulation demonstrated bioequivalence to the currently FDA-approved ALKINDI SPRINKLE oral granules.
  • Current KHINDIVI approval is limited to pediatric patients five years of age and older.
  • Eton anticipates a potential first half 2027 approval for the expanded age indication.
  • Adrenocortical insufficiency affects approximately 10,000 pediatric patients in the U.S.
  • KHINDIVI is an oral solution designed for patients who cannot swallow tablets or require gastric tube administration.
  • The product is not approved for stress dosing during acute events or infections.
  • Safety warnings highlight risks of hyperosmolarity, metabolic acidosis, hepato-renal injury, CNS toxicity, growth retardation, Cushing's syndrome, immunosuppression, psychiatric reactions, ophthalmic issues, gastrointestinal perforation, and Kaposi's sarcoma.
  • Inactive ingredients including polyethylene glycol 400, propylene glycol, and glycerin may cause systemic adverse reactions especially in children under five.
  • Eton Pharmaceuticals currently markets eleven rare disease products and has four candidates in late-stage development.