Khindivi FDA Approval History
Last updated by Judith Stewart, BPharm on March 6, 2025.
FDA Approved: Yes (First approved May 28, 2025)
Brand name: Khindivi
Generic name: hydrocortisone
Dosage form: Oral Solution
Previous Name: ET-400
Company: Eton Pharmaceuticals, Inc.
Treatment for: Adrenocortical Insufficiency
Khindivi (hydrocortisone) is an oral solution formulation of the approved corticosteroid hydrocortisone indicated as replacement therapy in pediatric patients 5 years of age and older with adrenocortical insufficiency.
- Adrenocortical insufficiency is a rare, but serious condition in which the adrenal glands do not produce sufficient cortisol.
- Khindivi contains hydrocortisone (cortisol), a well established replacement therapy for adrenocortical insufficiency that has been used for decades.
- Khindivi is the first and only FDA-approved oral solution formulation of hydrocortisone. It is a ready-to-use, berry flavored solution supplied in a convenient 1mg/mL strength, eliminating the need to split or crush tablets.
- Common adverse reactions for corticosteroids including hydrocortisone include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite, and weight gain.
Development timeline for Khindivi
Further information
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