FDA Approves AstraZeneca's SEROQUEL® for Bipolar Depression Treatment

"AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved SEROQUEL® (quetiapine fumarate) for the treatment of patients with depressive episodes associated with bipolar disorder. SEROQUEL already is approved for the treatment of acute manic episodes associated with bipolar I disorder and for the treatment of schizophrenia. SEROQUEL is now the first and only single medication approved by the FDA to treat both depressive and manic episodes associated with bipolar disorder.The FDA approval was based primarily on results from the clinical trial programme known as BOLDER (BipOLar DEpRession), which comprises the BOLDER I and BOLDER II studies. In these studies, patients taking SEROQUEL showed an improvement in depressive symptoms starting at week one compared to those taking placebo, and this improvement continued throughout the eight-week study. The recommended dose is 300 mg once-daily, to be achieved by day four of treatment....."

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