Eton Pharmaceuticals Wins FDA Approval for First Pediatric Hydrocortisone Oral Solution

Eton Pharmaceuticals has received FDA approval for KHINDIVI, the first and only hydrocortisone oral solution designed as a replacement therapy for pediatric patients aged five and older with adrenocortical insufficiency, a rare condition characterized by insufficient cortisol production. KHINDIVI offers precise, ready-to-use dosing in a 1mg/ml liquid formulation that eliminates the need for tablet splitting or crushing, and requires no refrigeration, mixing, or shaking, making it especially beneficial for children with swallowing difficulties or special administration needs such as gastric tubes. The product will be commercially launched through specialty pharmacy Anovo, supported by the Eton Cares Program which provides prescription fulfillment, insurance support, educational resources, and financial assistance, including co-pay aid. Eton expects combined peak sales of KHINDIVI and its other product, ALKINDI SPRINKLE, to exceed $50 million annually, strengthening its position in the rare disease treatment market. The approval and upcoming launch have been positively received by investors and analysts, with average stock price targets indicating significant potential upside. Eton’s CEO highlighted the approval as a major advance for pediatric patients and a testament to the company’s development and regulatory efforts.