Eton announces COVID-related delay in FDA approval
DEER PARK - Eton Pharmaceuticals Inc. said Friday its application for dehydrated alcohol injection for the treatment of methanol poisoning has not been approved at this time.
The U.S. Food & Drug Administration has reviewed Eton's new drug application and has determined it cannot be approved in its present form, Eton said.
A preapproval inspection of the product's European contract manufacturer is pending due to what the company believes are COVID-related travel restrictions. Eton said it believes all other FDA questions raised in the letter can be fully addressed in a response in the coming months.
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