FDA

Khindivi OK’d for adrenocortical insufficiency in children

June 6, 2025

Brand name: Khindivi

Generic name: hydrocortisone

Manufacturer: Eton Pharmaceuticals

Approval date: May 28, 2025

FDA approved Khindivi (hydrocortisone) oral solution as a replacement therapy in pediatric patients ≥5 years of age with adrenocortical insufficiency.

According to a manufacturer press release, Khindivi comes in a 1 mg/ml strength designed to avoid the need to split or crush tablets. It’s a ready-to-use oral liquid solution that doesn’t require refrigeration, mixing, or shaking.

Khindivi contains the inactive ingredients polyethylene glycol 400, propylene glycol, and glycerin. If patients experience adverse reactions (i.e., hyperosmolarity, metabolic acidosis, hypoglycemia, hepato-renal injury, CNS toxicity, GI adverse reactions), the Prescribing Information suggests consideration of discontinuing Khindivi and switching to another hydrocortisone product.

Sources:

Khindivi (hydrocortisone) [package insert]. Eton Pharmaceuticals. https://www.etonpharma.com/wp-content/uploads/2025/05/khindivi-pi.pdf Revised May 2025. Accessed June 5, 2025.

Eton Pharmaceuticals announces US FDA approval for Khindivi™ (hydrocortisone) oral solution. [News release]. 2025. https://ir.etonpharma.com/news-releases/news-release-details/eton-pharmaceuticals-announces-us-fda-approval-khindivitm