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It is not an FDA-approved finished drug product, is not a generic version of any FDA-approved drug, and has not been clinically studied as a finished product

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In patients with alcohol dependence and delirium unresponsive to high doses of benzodiazepines, alcoholic pellagra should be considered, since chronic alcoholism leads to a lack of tryptophan 2,3-dioxygenase, an enzyme linked to niacin synthesis

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