Eton Pharma Submits PAS to FDA for KHINDIVI Indication Expansion

Eton Pharmaceuticals announced the submission of a Prior Approval Supplement (PAS) to the U.S. Food and Drug Administration (FDA) for KHINDIVI® (hydrocortisone) oral solution. This submission seeks to expand the product's label to include younger pediatric patients, as the new formulation successfully demonstrated bioequivalence to ALKINDI SPRINKLE®. The company anticipates a potential approval for the expanded indication in the first half of 2027, aiming to address the largest need for an FDA-approved oral liquid hydrocortisone in children under five.