The FDA issued its second complete response letter to Eton Pharmaceuticals for its treatment to counter methanol poisoning, which occurs from ingesting household products like antifreeze and varnish.
Eton said Wednesday in a release that the CRL is “primarily” related to chemistry manufacturing and controls for its dehydrated alcohol injection. It did not share any additional details. The Deerpark, IL-based pharma said all of the issues raised by the FDA can be addressed, and it’s working on an action plan.
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