AstraZeneca received approval from the FDA for Seroquel for the treatment of patients with depressive episodes associated with bipolar disorder. Seroquel was previously 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 acute manic episodes associated with the disorder.

More than seven million American adults are affected by bipolar disorder, a serious psychiatric condition also known as manic depressive illness.

The approval was based on results from the clinical trial program known as BOLDER (BipOLar DEpRession). 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. Patients treated with Seroquel also showed significant improvement on other measures of efficacy including overall quality of life and satisfaction related to functioning.