Eton Pharma submits FDA supplement to expand KHINDIVI label to younger pediatric patients - ETON News | RalliesEton Pharma submits FDA supplement to expand KHINDIVI label to younger pediatric patients
E
ETON• FDA supplement targets 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.
SWKS
•
