AstraZeneca submits European application for drepression drug Seroquel XR

Published: 13-Jun-2008

AstraZeneca has made a European application for once-daily Seroquel XR extended-release tablets (quetiapine XR), for the treatment of major depressive disorder (MDD), including maintenance therapy in adult patients using the Mutual Recognition Procedure (MRP).


AstraZeneca has made a European application for once-daily Seroquel XR extended-release tablets (quetiapine XR), for the treatment of major depressive disorder (MDD), including maintenance therapy in adult patients using the Mutual Recognition Procedure (MRP).

This move follows a supplementary New Drug Application (sNDA) submission for Seroquel XR (quetiapine fumarate) in MDD in the US in February this year.

Each year, around 33 million people will suffer from MDD in Europe. Today, it is treated with generic or branded antidepressants, including selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs). Studies have shown at least one-third of patients fail to achieve a satisfactory response with current antidepressant therapy. Seroquel XR is the first atypical antipsychotic medicine to be submitted in Europe for approval for the treatment of MDD.

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