India, May 28 -- Eton Pharmaceuticals Inc. (ETON) announced that the U.S. Food and Drug Administration has approved a New Drug Application (NDA) for KHINDIVI (hydrocortisone) Oral Solution. The drug is intended as a replacement therapy for pediatric patients aged five years and older with adrenocortical insufficiency.
KHINDIVI is the only FDA-approved oral solution formulation of hydrocortisone. It comes in a 1mg/ml strength designed to eliminate the need to split or crush tablets, and to offer simple and accurate dosing specifically tailored to each patient's needs. It does not require refrigeration, mixing, or shaking - it is a ready-to-use oral liquid solution, the company said in a statement.
Adrenocortical insufficiency is a rare, bu...