News & Analysis » US

AstraZeneca Says EC Issues Positive Decision For Approval Of SEROQUEL XR Extended Release Tablets - Quick Facts

(RTTNews) - AstraZeneca Plc (AZN, AZN.L) announced that the European Commission has issued a positive decision for the approval of once-daily SEROQUEL XR Extended Release Tablets as an add-on treatment of major depressive episodes in patients with Major Depressive Disorder who have had sub-optimal response to antidepressant monotherapy. ?  The company noted that the decision follows a positive recommendation by the Committee for Medicinal Products for Human Use in April of this year. ?  AstraZeneca sated that it will now move forward in obtaining local approvals. ?  Within the 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.