FDA Grants Approval for Hydrocortisone Oral Solution for Some With Rare Adrenocortical Insufficiency

Officials with the FDA have approved the new drug application for the only hydrocortisone oral solution (Khindivi, Eton Pharmaceuticals) as a replacement therapy in pediatric patients 5 years of age and older with adrenocortical insufficiency.¹

“Managing adrenal insufficiency in pediatric patients requires precise and consistent hydrocortisone dosing that can be carefully titrated to small increments that address the individualized pharmacokinetic needs of each child,” said Kyriakie Sarafoglou, MD, who is a professor in the Division of Pediatric Endocrinology and Division of Pediatric Genetics and Metabolism at the University of Minnesota, in a press release about the approval.

Serious adverse reactions associated with Khindivi include adrenal crisis, systemic adverse reactions due to inactive ingredients, immunosuppression and increased risk of infection with dosage greater than replacement, Cushing’s syndrome, growth retardation, Kaposi’s sarcoma risk, and psychiatric, ophthalmic, and gastrointestinal adverse reactions.

Reference

1. Eton Pharmaceuticals. Eton Pharmaceuticals announces U.S. FDA approval for Khindivi (hydrocortisone) oral solution. [press release]. May 28, 2025. Accessed July 10, 2025. https://ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-announces-us-fda-approval-khindivitm