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AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression
Date:1/3/2008

WILMINGTON, Del., Jan. 2 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) 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 patients suffering from bipolar mania. The bipolar depression submission is supported by a clinical study of once-daily treatment with SEROQUEL XR, compared to placebo, with a primary endpoint of change from baseline in MADRS (Montgomery Asberg Depression Rating Scale) total score after 8 weeks of treatment, in 280 patients diagnosed with bipolar depression(1). Doses of SEROQUEL XR administered in both the bipolar mania (400 mg to 800 mg/day) and bipolar depression (300 mg/day) studies were comparable to the FDA-approved recommended doses for SEROQUEL (quetiapine fumarate) immediate release tablets in those indications(1,2). Both studies met their primary endpoint and it is expected that they will be presented at major scientific congresses in 2008.

SEROQUEL XR is currently approved in 8 countries including the U.S., Canada and The Netherlands, for the acute and maintenance treatment of schizophrenia in adults.

Launched in 1997, SEROQUEL has been prescribed to millions of patients worldwide. It is approved in 88 countries for the treatment of schizophrenia, in 79 countries for the treatment of bipolar mania, and in 11 countries including the U.S. for the treatment of bipolar depression. SEROQUEL XR was launched for the treatment of schizophrenia in the U.S. in 2007, an
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SOURCE AstraZeneca
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