Posted by Michael Wonder on 29 Jun 2023
Eton Pharmaceuticals receives complete response letter for dehydrated alcohol injection
28 June 2023 - Eton Pharmaceuticals announced today that the US FDA issued a complete response letter in response to its new drug application for dehydrated alcohol injection for the treatment of methanol poisoning.
The issues raised in the letter relate primarily to Chemistry Manufacturing and Controls. The Company believes all issues in the letter are addressable and will develop a comprehensive action plan to address the FDA’s concerns.
