AstraZeneca receives warning on Seroquel sales aid

Share this article:
The FDA asked AstraZeneca to halt distribution of a professional sales aid for its antipsychotic medication Seroquel. In a warning letter to AstraZeneca, the FDA’s Division of Drug Marketing, Advertising & Communications division wrote that the Seroquel sales aid is 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’s labeling says neuroleptic malignant syndrome, which can be fatal, has been reported in association of antipsychotic drugs, including Seroquel. AstraZeneca has until Nov. 30 to respond to the warning. Seroquel had global sales of $2.8 billion last year.
Share this article:
You must be a registered member of MMM to post a comment.

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...