ASTRA ZENECA: Llamada al orden por la FDA por promoción "off-label" de SEROQUEL

The comments, according to the agency, created a new "intended use" for Seroquel and Seroquel XR for which the products lack adequate directions. The FDA said that in addition to the reps oral comments, AstraZeneca sent a mailing to the same healthcare professional regarding unapproved uses for Seroquel. The agency said these promotional activities and materials misbrand the drugs in violation of the Federal Food, Drug and Cosmetic Act.

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