FDA Accepts Eton Pharma's Application for ET-400 (Hydrocortisone Oral Solution)

Eton Pharmaceuticals, Inc, a company known for its innovative approach in the pharmaceutical industry, has announced a major development in its product portfolio. The U.S. Food and Drug Administration (FDA) has accepted Eton's New Drug Application (NDA) for ET-400, a unique patented formulation of hydrocortisone oral solution. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date for this application on February 28, 2025.

Sean Brynjelsen, CEO of Eton Pharmaceuticals, expressed enthusiasm about the FDA's acceptance of their NDA, highlighting the significance of this milestone for the company's efforts to provide this crucial liquid formulation to children. Brynjelsen is optimistic that once approved, ET-400 will help Eton capture a more substantial share of the oral hydrocortisone market. He foresees that combined with ALKINDI SPRINKLE®, the product will achieve peak annual sales exceeding $50 million. The company is preparing for a potential launch in early 2025, working closely with the FDA in the interim.

ET-400 distinguishes itself as a proprietary formulation of oral hydrocortisone that remains stable at room temperature. The U.S. Patent and Trademark Office has granted a patent for ET-400, which will remain in effect until 2043. Additionally, Eton Pharmaceuticals has other related patent applications in the pipeline, currently under review.

Eton Pharmaceuticals specializes in the development and commercialization of treatments aimed at rare diseases. The company has already successfully brought five rare disease products to the market. These include ALKINDI SPRINKLE®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. Beyond these commercial products, Eton is also in the late stages of developing three additional candidates: ET-400, ET-600, and ZENEO® hydrocortisone autoinjector.

This latest development signifies a crucial advancement in Eton Pharmaceuticals' mission to innovate and provide essential treatments for rare diseases. The acceptance of the NDA for ET-400 by the FDA is a promising step towards expanding their market share and enhancing their product offerings. Eton Pharmaceuticals continues to focus on delivering high-demand medications, aiming for significant growth and success in the pharmaceutical industry.