AstraZeneca wins FDA approval for new bipolar disorder drug

AstraZeneca has received the FDA's approval for once-daily Seroquel 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 extended-release (XR) is said to be the first medication approved by the FDA for the once-daily acute treatment of both depressive and manic episodes associated with bipolar disorder. AstraZeneca submitted two separate supplemental new drug applications to the FDA to seek approval for these indications. The bipolar depression submission was supported by a clinical study of treatment with Seroquel XR compared with placebo in 280 patients diagnosed with bipolar depression. The... [read full story]