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January 2, 2008
By: Tim Wright
Editor-in-Chief, Contract Pharma
AstraZeneca submitted two sNDAs to the FDA for once-daily Seroquel XR Extended-Release Tablets in the following indications: treatment of manic episodes associated with bipolar disorder and treatment of depressive episodes associated with bipolar disorder. The bipolar mania submission is based on a study of once-daily treatment with Seroquel XR, compared to placebo, with a primary endpoint of change in YMRS (Young Mania Rating Scale) week three, in 316 patients suffering from bipolar mani...
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