ASTRAZENECA RECEIVES FDA COMPLETE RESPONSE LETTER ON SEROQUEL XR FOR MAJOR DEPRESSIVE DISORDER
AstraZeneca today announced the company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) asking for additional information for the supplemental New Drug Application for SEROQUEL XR (quetiapine fumarate) Extended Release Tablets for the treatment of Major Depressive Disorder (MDD) in adult patients.AstraZeneca is evaluating the contents of the CRL and the proposed labelling revisions. AstraZeneca will continue discussions with the FDA and will provide a response to the agency in due course.SEROQUEL XR, a once-daily, extended release