AstraZeneca has announced that the once-daily formulation SEROQUEL XR (quetiapine fumarate extended release tablets) and SEROQUEL (quetiapine fumarate) have been approved under the European Mutual Recognition Procedure (MRP) for new indications in bipolar disorder. SEROQUEL XR and SEROQUEL have been approved for the treatment of major depressive episodes in bipolar disorder.
Additionally, SEROQUEL XR has been licensed for moderate to severe manic episodes in bipolar disorder. This follows the October 2008 approval of SEROQUEL XR in similar indications by the US 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.
AstraZeneca will move forward with obtaining local approvals with the 17 Member States that take part in the Mutual Recognition Procedure. Bipolar disorder is a common and serious mental illness that causes dramatic and severe mood swings.