AstraZeneca has received approval under the European Mutual Recognition Procedure for Seroquel and Seroquel XR for the prevention of recurrence of bipolar disorder in patients.
The treatments have been approved for the prevention of recurrence of bipolar disorder in patients whose manic, mixed or depressive episodes have responded to quetiapine treatment.
Following the new indication Seroquel XR (quetiapine fumarate extended-release tablets) and Seroquel (quetiapine fumarate) are the only agents approved in the EU to treat all phases of bipolar disorder.
AstraZeneca has said it would now be moving forward with obtaining local approval from member states that take part in the Mutual Recognition Procedure.
Launched in 1997, Seroquel has been approved in 94 countries for schizophrenia, 91 countries for bipolar mania, in 51 countries for bipolar depression and in eight countries for bipolar maintenance.