FDA issues Complete Response Lette for NDA for dehydrated alcohol injection for the treatment of methanol poisoning
Eton Pharmaceuticals, Inc , an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced that the FDA issued a Complete Response Letter (CRL) in response to its New Drug Application (NDA) for dehydrated alcohol injection for the treatment of methanol poisoning
The issues raised in the CRL relate primarily to Chemistry Manufacturing and Controls (CMC). The Company believes all issues in the CRL are addressable and will develop a comprehensive action plan to address the FDA’s concerns.
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