FDA posts, removes briefing documents regarding Seroquel XR
WILMINGTON, Del. The Food and Drug Administration posted and then removed briefing documents on its Web site for the Psychopharmacologic Drugs Advisory Committee meeting Wednesday.
The meeting concerns an application that drug maker AstraZeneca submitted for an additional use of the drug Seroquel XR (quetiapine fumarate) as a treatment for major depressive disorder and generalized anxiety disorder.
The company said it understands that some people accessed the documents before their removal, and that it wishes to ensure all investors have access to the information contained in the previously released FDA briefing materials. For that reason, it has posted the documents, as well as AstraZeneca briefing documents, on its own Web site.