Eton Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's New Drug Application (NDA) response for dehydrated alcohol injection for the proposed indication of methanol poisoning. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2023.
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07-15 | Eton Pharma Shares Rise After FDA Accepts New Drug Application for ET-400 | DJ |
07-15 | 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 NDA Response for Dehydrated Alcohol Injection