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Home » Regulatory front
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Regulatory front

Jan. 22, 2016
In its first untitled letter of the year, the FDA's Office of Prescription Drug Promotion (OPDP) rapped Hospira Inc., a Pfizer Inc. company based in Lake Forest, Ill., for not submitting a promotional video touting Precedex (dexmedetomidine hydrochloride) before putting it on YouTube. The video also fails to include risk information and presents "arousability" as a benefit rather than a warning or precaution for the injected sedative labeled for use in surgery and other intensive care settings. In addition, the video doesn't spell out pertinent usage information, including the fact that the drug should not be infused for more than 24 hours. OPDP instructed Hospira to remove the video immediately and to respond to the letter by Jan. 29.
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