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 (hydrocortisone) oral solution to younger pediatric patients, following demonstration of bioequivalence to the approved ALKINDI SPRINKLE formulation.

Outcome Details

Prior Approval Supplement submitted to FDA for indication expansion to younger pediatric patients; bioequivalence to ALKINDI SPRINKLE demonstrated

Importance:6/10

Sentiment:

0.60

FDA submissionindication expansionpediatricrare diseasebioequivalencehydrocortisone

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Published by GlobeNewswire Clinical Studies on July 29, 2026 10:50 AM

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