Eton Pharmaceuticals Secures FDA Approval for KHINDIVI™ Oral Solution as Treatment for Pediatric Adrenal Insufficiency
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.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Eton Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9459659-en) on May 28, 2025, and is solely responsible for the information contained therein.
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