Eton Pharmaceuticals Announces FDA Acceptance of NDA Response for Dehydrated Alcohol Injection
— Product previously granted orphan drug designation for methanol poisoning —
— Application assigned a PDUFA date of June 27, 2023 —
DEER PARK, Ill., Jan. 11, 2023 (GLOBE NEWSWIRE) — Eton Pharmaceuticals (“Eton” or “the Company”) (Nasdaq:ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today 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.