For adrenocortical insufficiency. NDA 218980, held by Eton. Hydrocortisone.
As of Nov 13, 2026, NDA 218980 (Khindivi), held by Eton, was first approved by FDA on May 28, 2025, with 0 approved supplements and 0 published complete response letters.
KHINDIVI is indicated as replacement therapy in pediatric patients 5 years of age and older with adrenocortical insufficiency.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 28, 2025 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Khindivi1MG/ML · solution;oral | Hydrocortisone | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
