AstraZeneca's Regulatory Update For Seroquel XR

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Published: 29-May-2009

AstraZeneca has referred its application for Seroquel XR (quetiapine fumarate) extended release tablets, used for the treatment of recurrent depressive episodes in adult patients with major depressive disorder (MDD) to the Committee for Medicinal Products for Human Use.

This follows the notification to AstraZeneca by the Netherlands Health Authority (MEB), acting as the Reference Member State for the Mutual Recognition Process (MRP), that the Seroquel XR application for MDD has been refused.

The results from the clinical trial program demonstrated that Seroquel XR has potential as a valuable treatment option for patients with MDD. The proposed indication in the submitted marketing application for Seroquel XR is for the treatment of recurrent depressive episodes in patients with MDD, who are not appropriately managed on alternative antidepressant treatments, said the company.

Also, AstraZeneca has announced that the Canadian regulator, Health Canada, has approved Seroquel XR for the treatment of adult patients with MDD.

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