FX.co ★ Eton Pharmaceuticals Announces NDA Submission For ET-400

Eton Pharmaceuticals has submitted a New Drug Application for ET-400, their own unique patented formulation of a hydrocortisone oral solution, to the U.S. Food and Drug Administration (FDA). The firm predicts the application process, which is subject to a 10-month review by the FDA, will result in a possible approval and product launch in the first quarter of 2025.

CEO of Eton Pharmaceuticals, Sean Brynjelsen, confidently stated his belief that combined annual sales of ET-400, following approval, and Alkindi Sprinkle have the potential to surpass $50 million.

The U.S. Patent and Trademark Office has granted Eton a patent for ET-400, which will remain in effect until 2043.

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