AstraZeneca Will Collect Longer-Term Safety Data For Seroquel XR
AstraZeneca is committed to new studies and could modify ongoing observational studies to collect data on the long-term safety issues that troubled an FDA advisory panel during its consideration of Seroquel XR (quetiapine) for treating major depressive disorder and generalized anxiety disorder
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A second-line indication for AstraZeneca's Seroquel XR (quetiapine) in major depressive disorder and generalized anxiety disorder remains possible following a unanimous FDA advisory committee vote that the drug is not "acceptably safe" for the monotherapy claims in MDD and GAD that AstraZeneca had been seeking
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.