Quetiapine (Seroquel) approved by FDA as maintenance treatment of bipolar I disorder

May 20, 2008

AstrasZeneca's antipsychotic in combination with lithium or divalproex is okayed for bipolar maintenance.

AstraZeneca has been green-lighted to begin marketing quetiapine tablets (Seroquel) for a new indication. The antipsychotic may now be used for the maintenance treatment of patients with bipolar I disorder as adjunct to lithium or divalproex. Approval was based on two clinical trials which evaluated time to recurrence of depressive, manic, or mixed mood event. Pooled study results showed patients treated with quetiapine plus lithium or divalproex had a risk reduction of 70% relative to those receiving placebo plus lithium or divalproex. Quetiapine was previously approved for treating bipolar I disorder as both a monotherapy and as an adjunct to lithium or divalproex and schizophrenia.

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