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Eton Pharmaceuticals Submits NDA to FDA for ET-400 (Hydrocortisone Oral Solution)

• Eton Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for ET-400, a patented hydrocortisone oral solution, aimed at treating adrenocortical insufficiency. • The FDA review is expected to take 10 months, potentially leading to approval and market launch in the first quarter of 2025, addressing a critical need for children. • ET-400 is protected by a U.S. patent expiring in 2043, with additional patent applications pending, highlighting its unique formulation and market exclusivity. • Eton anticipates that ET-400, along with Alkindi Sprinkle, could achieve combined peak sales exceeding $50 million annually, reflecting strong demand from patients and physicians.

Eton Pharmaceuticals has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ET-400, a proprietary, patented formulation of hydrocortisone oral solution. The submission marks a significant step toward providing a much-needed treatment option for children with adrenocortical insufficiency. The company anticipates a 10-month review period by the FDA, potentially leading to approval and launch in the first quarter of 2025.

Addressing Adrenocortical Insufficiency

Adrenocortical insufficiency, a condition where the adrenal glands do not produce enough cortisol, can be life-threatening, especially in children. Hydrocortisone is a common treatment, but existing formulations may not be ideal for pediatric patients. ET-400 aims to provide a more convenient and palatable option, improving adherence and outcomes.

CEO's Perspective

"With the completion of the NDA submission for ET-400, we are one step closer to bringing this critical medication to children in need," said Sean Brynjelsen, CEO of Eton Pharmaceuticals. "We continue to see very strong demand from patients, caregivers, and physicians, and are confident that ET-400, once approved, and Alkindi Sprinkle can achieve potential combined peak sales of more than $50 million annually."

Patent Protection and Market Potential

Eton Pharmaceuticals has secured a U.S. patent for ET-400, which is set to expire in 2043, providing substantial market exclusivity. The company also has additional patent applications under review, further strengthening its intellectual property position. The anticipated combined peak sales of ET-400 and Alkindi Sprinkle underscore the significant market potential for these rare disease treatments.

Eton Pharmaceuticals' Focus

Eton Pharmaceuticals is dedicated to developing and commercializing treatments for rare diseases. The company currently markets five rare disease products, including ALKINDI SPRINKLE® and PKU GOLIKE®. ET-400 is one of three late-stage product candidates, highlighting Eton's commitment to addressing unmet needs in the rare disease space.
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Reference News

[1]
Eton Pharmaceuticals Announces Submission to FDA of New Drug Application for ET-400 (Hydrocortisone Oral Solution)
drugs.com · Apr 30, 2024

Eton Pharmaceuticals submits New Drug Application to FDA for ET-400 (hydrocortisone oral solution), expecting a 10-month...

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