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FDA Approves AstraZeneca’s Seroquel XR for the Treatment of Bipolar Depression and Bipolar Mania in the US


AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR (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.

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

“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.”

About bipolar disorder
Bipolar disorder consists of recurring episodes of mania and depression. Bipolar I disorder is characterised by one or more manic or mixed episodes, often with one or more episodes of major depression, whereas bipolar II disorder is distinguished by one or more major depressive episodes accompanied by at least one hypomanic episode. Patients with bipolar I disorder experience depressive symptoms – approximately three times longer than manic symptoms. Similarly, patients with bipolar II disorder spend almost forty times longer in the depressed state than in hypomania. Bipolar disorder is typically managed through a treatment strategy with several phases – including acute and maintenance phases. In the acute phase, the aim is to improve the acute symptoms of the patient; the maintenance treatment phase aims to reduce the risk of recurrence of future episodes.

About AstraZeneca
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world’s leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information visit


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