AstraZeneca´s Seroquel, Seroquel XR Gets Approval In Europe For Bipolar Disorder

AstraZeneca Plc schizophrenia drug Seroquel, won European approval for wider use of both the original and the new version (XR) of its blockbuster antipsychotic in treating major depressive episodes in bipolar disorder. Seroquel XR has also been cleared for the treatment of moderate to severe manic episodes in bipolar disorder.

11-13-2008 | 09:23 hs.

Anglo-Swedish drug firm AstraZeneca Plc announced that its anti-psychotic drugs Seroquel and Seroquel XR have been approved in Europe for the treatment of major depressive episodes in bipolar disorder. Seroquel XR has also been cleared for the treatment of moderate to severe manic episodes in bipolar disorder in Europe.

Seroquel (quetiapine) was originally approved by the FDA in 1997 to treat the symptoms of schizophrenia. Seven years later, the company won FDA approval to expand use of Seroquel to treat mania associated with bipolar disorder.

The approvals were obtained under the European Mutual Recognition Procedure (MRP) and AstraZeneca will now push ahead with securing local approvals with the 17 states that take part in the MRP.

Seroquel XR was approved to control depressive and manic symptoms of bipolar disorder in the U.S. last month.

First nine month sales of the drug were $3.3 billion.