FDA acceptance of NDA response for dehydrated alcohol injection to treatmethanol poisoning
Eton Pharmaceuticals announced that the 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.
Eton’s application has previously been granted orphan drug designation for the indication of methanol poisoning and if approved, the Company expects the FDA to grant the application seven years of orphan drug exclusivity. Based on IQVIA data, trailing twelve month sales for dehydrated alcohol injection were $74 million..
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