AstraZeneca today announced that the once-daily formulation SEROQUEL XR™ (quetiapine fumarate extended release tablets) and SEROQUEL® (quetiapine fumarate) have been approved via the Mutual Recognition Procedure for new indications in bipolar disorder. SEROQUEL XR and SEROQUEL have been approved for treatment of major depressive episodes in bipolar disorder. Additionally, SEROQUEL XR has been approved for treatment of moderate to severe manic episodes in bipolar disorder.
This follows the October 2008 approval of SEROQUEL XR in similar indications by the U.S. Food and Drug Administration (FDA). As a result of these new indications for adult patients, SEROQUEL (both formulations) is currently the only atypical antipsychotic approved to treat the spectrum of mood episodes associated with bipolar disorder and the only licensed treatment for bipolar depression in the EU. The mechanism of action of SEROQUEL, which involves both antipsychotic and antidepressant activities, may help explain its unique efficacy across the spectrum of mood episodes associated with bipolar disorder.
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