Eton submits PAS to expand KHINDIVI indication to younger pediatric patients

Eton Pharmaceuticals, Inc.

Submitted Prior Approval Supplement to FDA to expand KHINDIVI label to include children under age 5.
New formulation demonstrated bioequivalence to ALKINDI SPRINKLE oral granules.
Potential expanded indication approval expected in first half 2027.
KHINDIVI is the only FDA-approved oral solution of hydrocortisone; currently approved for ages 5+.
CEO estimates ~10,000 pediatric adrenal insufficiency patients in the U.S.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.