• 30 May 2025
• Admin
• News Article

Eton Pharmaceuticals Secures FDA Approval for KHINDIVI Oral Solution

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. Developed at a 1 mg/mL strength, the product supports precise and convenient dosing without the need to split or crush tablets.

It is a ready-to-use solution that requires no refrigeration, mixing, or shaking—designed especially for patients with swallowing difficulties or those using gastric tubes.

Indicated for Pediatric Patients Aged Five Years and Older

KHINDIVI is approved as a replacement therapy for pediatric patients aged five years and older with adrenocortical insufficiency. This rare condition occurs when the adrenal glands do not produce adequate levels of cortisol, a hormone essential for metabolic function and stress response.

Accurate dosing is crucial in managing pediatric adrenal insufficiency, as hormone levels must be carefully adjusted to match the needs of growing children. KHINDIVI offers a solution that allows for fine dose titration, supporting personalized treatment plans and improved disease management.

Addressing a Critical Need in Pediatric Endocrinology

The approval of KHINDIVI follows years of advocacy by healthcare professionals and patient groups for a liquid hydrocortisone option approved by the FDA. The formulation addresses an important unmet need, allowing for incremental dose adjustments that tablets cannot reliably provide.

KHINDIVI is expected to improve clinical outcomes and ease the treatment burden for both caregivers and clinicians.

Commercial Launch and Support Program

Eton Pharmaceuticals plans to make KHINDIVI available in the United States within days through exclusive distribution by Anovo, a specialty pharmacy that serves patients with rare and chronic conditions.

The company will also support patients through its Eton Cares Programme, which offers:

• Insurance and reimbursement support
• Financial assistance for eligible families
• Educational resources
• Co-pay support to reduce out-of-pocket costs

Expanding Eton’s Pediatric Endocrin ology Portfolio

KHINDIVI complements Eton’s existing product ALKINDI SPRINKLE, a hydrocortisone-based granule formulation for younger children with adrenal insufficiency. Together, the two products aim to enhance treatment options and access for families managing this lifelong condition.

Eton estimates that more than 5,000 children between the ages of 5 and 17 in the United States are affected by adrenal insufficiency. The combined peak annual sales of KHINDIVI and ALKINDI SPRINKLE are expected to exceed 50 million dollars.