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Seroquel supplement for anxiety submitted

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

AstraZeneca's Seroquel XR would be the first atypical antipsychotic marketed for generalized anxiety disorder, if the sNDA submitted May 7 is approved. The GAD submission is part of AstraZeneca's larger attempts to expand Seroquel's label: additional submissions were made for major depressive disorder and bipolar mania and depression in January and February 2008. AstraZeneca is also considering Seroquel XR in pediatric patients and as an adjunct to serotonin and norepinephrine reuptake inhibitors and SSRIs. Seroquel XR loses exclusivity in 2010. Three short-term and one long-term placebo-controlled trials support the GAD sNDA; all met their primary endpoint

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