Eton Pharmaceuticals Inc., an innovative pharmaceutical company focusing on treatments for rare diseases, has announced U.S. FDA approval for its New Drug Application (NDA) for KHINDIVI™ (hydrocortisone) Oral Solution. This marks the first and only FDA-approved hydrocortisone oral solution, designed as a replacement therapy for pediatric patients aged five years and older with adrenocortical insufficiency. The commercial launch is anticipated the week of June 2nd. This approval represents a significant advancement for families dealing with pediatric congenital adrenal hyperplasia $(CAH)$, offering a more accurate dosing option than previously available. Eton expects peak combined sales of KHINDIVI and ALKINDI SPRINKLE® to exceed $50 million.
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