AstraZeneca 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.

Seroquel XR has been approved in 43 countries for schizophrenia (including all 17 countries in the Mutual Recognition Procedure), 12 countries for bipolar mania, in 7 countries for bipolar depression, in 3 markets for bipolar maintenance, in 1 market for Major Depressive Disorder (MDD), and in 1 market for Generalised Anxiety Disorder (GAD).

Launched in 1997, it is estimated that Seroquel has been prescribed to more than 22 million patients worldwide. It is approved in 92 countries for the treatment of schizophrenia, in 88 countries for the treatment of bipolar mania, and in 30 countries including the US for the treatment of bipolar depression.

AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services.