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June 28 : The FDA declined to approve Eton Pharmaceuticalsdehydrated alcohol injection for the treatment of methanol poisoning, citing concerns related primarily to Chemistry Manufacturing and Controls. This is the second Complete Response Letter issued to Eton for this proposed treatment
Strive accreditations indicate they exceed minimum compounding standards, but the testing framework is inherently different from FDA-regulated manufacturing
Some people may have idiosyncratic reactions
FDA-approved versions of the drugs are manufactured and packaged under tightly controlled conditions designed to preserve that stability through shipping and storage
At the 12mg dose, that figure jumped to 20.9%
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