Eton Pharma submits FDA supplement to expand KHINDIVI label to younger pediatric patients

• Eton Pharmaceuticals filed an FDA prior approval supplement to expand KHINDIVI hydrocortisone oral solution use to younger pediatric patients.
• Submission targets a larger share of the pediatric adrenal insufficiency market; KHINDIVI is currently cleared for ages 5 and older.
• Eton expects a potential FDA decision in the first half of 2027; the new formulation met bioequivalence to ALKINDI SPRINKLE.

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