Eton Pharmaceuticals submits FDA supplement to expand KHINDIVI to younger children

Eton Pharmaceuticals announced on July 29, 2026 that it had submitted a Prior Approval Supplement to the FDA seeking to expand the label for KHINDIVI (hydrocortisone) oral solution to cover younger pediatric patients. The submission followed successful bioequivalence testing of a new KHINDIVI formulation against ALKINDI SPRINKLE, the FDA-approved hydrocortisone granule product.¹

KHINDIVI is currently approved only for patients ages five and above.¹ CEO Sean Brynjelsen said the filing targets what the company sees as the biggest unmet need in the market, noting that the largest need for an FDA-approved oral liquid hydrocortisone remains with children under age five.¹ He added that the company is now one step closer to a potential label expansion in the first half of 2027.¹

KHINDIVI holds a unique position in its category: it is the only FDA-approved oral solution of hydrocortisone, having been approved in May 2025 for replacement therapy in adrenocortical insufficiency in patients five years and older.¹ According to Eton, the product's design goal was to give caregivers a precise, ready-to-use liquid option that avoids tablet manipulation or the use of non-FDA-approved compounded suspensions, and to serve patients who cannot swallow tablets or who need administration through devices such as a gastric tube.¹

The company described adrenocortical insufficiency as a rare but serious condition in which the adrenal glands fail to produce enough cortisol,¹ and estimated roughly 10,000 pediatric patients with adrenal insufficiency in the United States.¹ No FDA decision date beyond the stated first-half-2027 target was given in the release.