Eton Pharma submits FDA supplement to expand KHINDIVI label to younger pediatric patients

Reuters2026/07/29 10:54

By:Reuters

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Eton Pharmaceuticals filed an FDA prior approval supplement to expand KHINDIVI hydrocortisone oral solution use to younger pediatric patients.
Submission targets a larger share of the pediatric adrenal insufficiency market; KHINDIVI is currently cleared for ages 5 and older.
Eton expects a potential FDA decision in the first half of 2027; the new formulation met bioequivalence to ALKINDI SPRINKLE.

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 on July 29, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Eton Pharma submits FDA supplement to expand KHINDIVI label to younger pediatric patients

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