Eton Pharmaceuticals Announces NDA Submission For ET-400

(RTTNews) - Eton Pharmaceuticals (ETON) announced the submission of a New Drug Application to the FDA for approval of ET-400, Eton's proprietary patented formulation of hydrocortisone oral solution. The company expects the application to be assigned a 10-month FDA review, allowing for potential approval and launch in the first quarter of 2025.

"We are confident that ET-400, once approved, and Alkindi Sprinkle can achieve potential combined peak sales of more than $50 million annually," said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

Eton has been issued a patent by the U.S. Patent and Trademark Office on ET-400, which expires in 2043.

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