GlobeNewswire PharmaOriginal article
Eton Pharmaceuticals Announces Submission of Prior Approval Supplement to Expand Indication of KHINDIVI® (hydrocortisone) Oral Solution
NDA FilingKHINDIVIALKINDI SPRINKLEPositive
AI Analysis
Summary
Eton Pharmaceuticals submitted a Prior Approval Supplement to the FDA to expand KHINDIVI's label to younger pediatric patients following successful bioequivalence demonstration to ALKINDI SPRINKLE. The expanded indication would lower the minimum age from five years.
Outcome Details
Prior Approval Supplement submitted to expand indication to younger pediatric patients; bioequivalence to ALKINDI SPRINKLE demonstrated
Importance:5/10
Sentiment:
0.60
label expansionpediatric indicationbioequivalencerare diseaseregulatory submission
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Published by GlobeNewswire Pharma on July 29, 2026 10:50 AM