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Article: AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression.
- Article from:
- PR Newswire
- Article date:
- January 2, 2008
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WILMINGTON, Del., Jan. 2 /PRNewswire-FirstCall/ -- AstraZeneca today announced that the company has submitted two separate supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for once-daily SEROQUEL XR(TM) (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes associated with bipolar disorder.
The bipolar mania submission is based on a clinical study of once-daily treatment with SEROQUEL XR, compared to placebo, with a primary endpoint of change in YMRS (Young Mania Rating Scale) total score (week 3), in 316 ...