Eton Pharmaceuticals, Inc. announced the Company's New Drug Application (NDA) for ET-400, a proprietary patented formulation of hydrocortisone oral solution, has been accepted by the U.S. Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2025. ET-400 is a proprietary room temperature stable formulation of oral hydrocortisone solution. The Company has been issued a patent related to the product by the U.S. Patent and Trademark Office that expires in 2043 and has additional patent applications currently under review.
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15/07 | Eton Pharma Shares Rise After FDA Accepts New Drug Application for ET-400 | DJ |
15/07 | Eton Pharmaceuticals Shares Surge After FDA Accepts ET-400 New Drug Application For Review | MT |
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- Eton Pharmaceuticals Announces Fda Acceptance of New Drug Application for Et-400 (Hydrocortisone Oral Solution)