FDA warns AZ of off-label promotion case
Anglo-Swedish drug major AstraZeneca has received a warning letter from US regulators after an unidentified sales representative pitched one of its drugs to a doctor for an unapproved indication.
The US Food and Drug Administration's Division of Drug Marketing, Advertising and Communications informed AstraZeneca that one of its reps and a mailing from the company itself recommended or suggested the use of Seroquel (quetiapine fumarate) for major depressive disorder, an indication for which it is not approved.
A company spokeswoman said that AstraZeneca is conducting a full investigation into the alleged case of off-label promotion.
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