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FDA Permitting Norepinephrine Injection Imports only by Sandoz

The Food and Drug Administration has issued a letter announcing that Sandoz is coordinating with FDA to increase the availability of the norepinephrine bitartrate injection due to the current critical shortage. FDA states that at this time, no other company…

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except Sandoz is authorized by FDA to import norepinephrine bitartrate injection for distribution. Any sales of imported Norepinephrine from any entity other than Sandoz will be considered in violation of the Federal Food, Drug and Cosmetic Act and may be subject to enforcement action by the FDA.