European Commission Issues Positive Decision for Approval of Seroquel XR

Friday, 03 September 2010

AstraZeneca announced that the European Commission (EC) has issued a positive decision for the approval of once-daily SEROQUEL XR (quetiapine fumarate) Extended Release Tablets as an add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had sub-optimal response to antidepressant monotherapy.

This decision follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) in April of this year.

AstraZeneca will now move forward in obtaining local approvals. This is a 30 day process in the 17 member states that took part in the original Mutual Recognition Procedure. For other member states timelines will vary.

Within this application, the product information for SEROQUEL XR has been updated with respect to several individual safety topics such as: suicidality, weight gain, hyperglycaemia, extrapyramidal symptoms, akathisia, somnolence, orthostatic hypotension, and dizziness. Guidance is also provided on safe administration of SEROQUEL XR, including consideration of the safety profile with respect to the individual patient's diagnosis and the dose being administered. Implementation of this updated product information will occur upon obtaining local approval.

About SEROQUEL XR
To date, SEROQUEL XR has been approved in 72 countries for schizophrenia, 57 countries for bipolar mania, 49 countries for bipolar depression, 33 countries for bipolar maintenance, 6 countries for MDD, with US receiving approval of SEROQUEL XR for the adjunctive treatment of MDD in December 2009, and 3 countries for Generalised Anxiety Disorder (GAD).

About EC Member States
The 17 member states that took part in the original SEROQUEL XR Mutual Recognition Procedure were: Austria, Belgium, Cyprus, Denmark, Finland, Germany, Greece, Iceland, Ireland, Luxembourg, Netherlands, Norway, Malta, Portugal, Poland, Spain, and Sweden.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit: www.astrazeneca.com.