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FDA Approves AstraZeneca's SEROQUEL XR(R) for the Treatment of Bipolar Depression and Bipolar Mania
Date:10/10/2008

WILMINGTON, Del., Oct. 10 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR(R) (quetiapine fumarate) Extended-Release Tablets for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex. SEROQUEL XR is the first medication approved by the FDA for the once-daily acute treatment of both depressive and manic episodes associated with bipolar disorder.(1)

"When people think about bipolar disorder it is important to remember how debilitating the depressive episodes of the disease can be. In fact, in the long term, patients with bipolar disorder experience depressive symptoms three times longer than manic symptoms," said Dr. Trisha Suppes, Professor of Psychiatry and Behavioral Sciences, Stanford University Medical Center and VA Palo Alto Health Care System. "With the approval of SEROQUEL XR for the treatment of bipolar depression and mania, we have a once-daily treatment that has been proven to help control the depressive and manic symptoms of bipolar disorder."

"These new indications for SEROQUEL XR mark an important milestone in the treatment of bipolar disorder," said Lisa Schoenberg, VP Specialty Care, AstraZeneca. "In addition to today's approval for the treatment of both the depressive and manic symptoms associated with this condition, SEROQUEL XR is now also approved as a long-term treatment option for bipolar I disorder."

About the SEROQUEL XR Bipolar Disorder Approval

Bipolar disorder, also known as manic depressive illness, is a serious psychiatric condition that consists of recurring episodes of depression and mania.(2) Approximately 8 million American adults may be affected by bipolar disorder.(3,4)

AstraZeneca submitted two separate
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SOURCE AstraZeneca
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