Breakthrough FDA Approval: New Liquid Hydrocortisone Treatment Targets 5,000 Pediatric Patients with $50M Market Potential

FDA Approves Hydrocortisone Oral Solution for Adrenocortical Insufficiency

The replacement therapy is indicated for patients 5 years and older, marking the first approval for an oral solution form of hydrocortisone.

FDA Approves Khindivi, First Oral Solution of Hydrocortisone, for Pediatric Patients

The formulation allows for individualized treatment in children with adrenocortical insufficiency.

FDA Approves Hydrocortisone Oral Solution for Adrenal Insufficiency

The FDA approves hydrocortisone oral solution for pediatric adrenal insufficiency, enhancing dosing accuracy and ease for young patients and caregivers.

FDA approves hydrocortisone oral solution for children 5 years, older with adrenocortical insufficiency

The decision makes hydrocortisone oral solution (Khindivi; Eton Pharmaceuticals) the only FDA-approved oral formulation of hydrocortisone.

Eton’s application for hydrocortisone oral solution wins FDA nod

Eton Pharmaceuticals’ NDA for Khindivi, an oral solution of hydrocortisone, has received US Food and Drug Administration (FDA) approval.

Breakthrough FDA Approval: New Liquid Hydrocortisone Treatment Targets 5,000 Pediatric Patients with $50M Market Potential

First FDA-approved liquid hydrocortisone offers precise dosing for children with adrenal insufficiency. Immediate launch targets 5,000+ patients. See launch details.