AstraZeneca Submits SEROQUEL Application to Committee for Medicinal Products for Human Use
Fri, 05/29/2009 - 4:32am
AstraZeneca has has referred its application for SEROQUEL XR (quetiapine fumarate) Extended Release Tablets for the treatment of recurrent depressive episodes in adult patients with major depressive disorder (MDD) to the Committee for Medicinal Products for Human Use (CHMP; a scientific committee of the European Medicines Agency, EMEA). This follows 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. AstraZeneca believes that results from the clinical trial programme demonstrate 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. Also today, AstraZeneca announced that the Canadian regulators, Health Canada, have approved SEROQUEL XR for the treatment of adult patients with MDD.