05:49 PM EDT, 05/28/2025 (MT Newswires) -- Eton Pharmaceuticals ( ETON ) said Wednesday the US Food and Drug Administration approved a new drug application for Khindivi, a hydrocortisone oral solution, as replacement therapy in pediatric patients aged five and older with adrenocortical insufficiency.

The ready-to-use formulation does not require refrigeration and allows for accurate, individualized dosing.

Khindivi will be available in the US in the coming days through the specialty pharmacy Anovo.

Eton said it expects combined peak sales of Khindivi and its existing hydrocortisone product, Alkindi Sprinkle, to exceed $50 million annually.

Shares of Eton Pharmaceuticals ( ETON ) were up nearly 2% in after-hours trading.