Eton Pharmaceuticals Secures FDA Approval for KHINDIVI Oral Solution
Thursday, May 29, 2025
Eton Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for KHINDIVI™ (hydrocortisone) Oral Solution.
KHINDIVI is now the only FDA-approved oral liquid formulation of hydrocortisone. Available in a 1mg/ml strength, it has been developed to support accurate dosing without the need to split or crush tablets. The ready-to-use solution does not require refrigeration, mixing, or shaking, offering convenience for patients with swallowing difficulties or those using a gastric tube.
The product is indicated as a replacement therapy for paediatric patients aged five years and older with adrenocortical insufficiency.
The approval marks a significant step for the treatment of paediatric adrenal insufficiency, a rare condition where the adrenal glands fail to produce sufficient cortisol. Accurate dosing is essential in managing this condition, especially in growing children who require carefully adjusted therapy. KHINDIVI aims to address this need with a more precise and manageable treatment option.
The introduction of KHINDIVI follows ongoing calls from healthcare professionals and patient groups for an FDA-approved hydrocortisone liquid. The new formulation is expected to support better clinical outcomes by allowing smaller, incremental dose adjustments tailored to each child’s requirements.
Eton Pharmaceuticals plans to make KHINDIVI available in the United States within days, distributing it exclusively through Anovo, a specialty pharmacy focused on rare and chronic conditions. The company will also extend its support through the Eton Cares Programme, offering services such as insurance support, education, financial assistance for eligible patients, and co-pay support to reduce treatment costs.
KHINDIVI will join Eton’s existing portfolio, which includes ALKINDI SPRINKLE, another hydrocortisone-based therapy for younger paediatric patients with adrenal insufficiency. Together, these treatments aim to improve access and choice for families managing this lifelong condition.
Eton estimates there are over 5,000 patients between the ages of 5 and 17 in the United States affected by adrenal insufficiency. Combined peak annual sales of KHINDIVI and ALKINDI SPRINKLE are expected to exceed $50 million.
Source: etonpharma.com
