May 8, 2008-AstraZeneca today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of generalised anxiety disorder (GAD), including maintenance of antianxiety effect. It is the first time approval has been sought for an atypical antipsychotic medicine in GAD.
The submission is based on a robust clinical development programme involving more than 3,000 patients. This week, at the 161stAnnual Meeting of the American Psychiatric Association (APA) in Washington, D.C., data from two of the studies (Studies 9 and 12) supporting the submission, were presented. In the data presented, significantly greater symptom improvements were seen in patients treated with SEROQUEL XR compared to those treated with placebo, in short-term and maintenance treatment, with safety and tolerability consistent with the known safety profile of quetiapine.
The details can be read here.
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