AstraZeneca gets warning on Seroquel promotional material from US regulator
AstraZeneca has been warned by US regulators that sales material for its antipsychotic Seroquel (quetiapine) is misleading. The Food and Drug Adminsitration has requested the Anglo-Swedish drug major to stop distributing it.
The FDA's Division of Drug Marketing, Advertising, and Communications reviewed a professional sales aid for Seroquel and decided it was "false or misleading because it minimizes the risk of hyperglycemia and diabetes mellitus and fails to communicate important information regarding neuroleptic malignant syndrome, tardive dyskinesia and the bolded cataracts precaution."
Seroquel is a blockbuster drug indicated for the treatment of acute manic episodes associated with bipolar disorder, as well as for the treatment of schizophrenia. The agent earned $848.0 million in third-quarter 2006 (Marketletter November 6) and netted $2.8 billion in full-year 2005.
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