AstraZeneca is evaluating the contents of the complete response letter (CRL) and the proposed labeling 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 formulation of Seroquel (quetiapine fumarate), was approved in the US in 2007 for the acute and maintenance treatment of schizophrenia in adult patients and in October 2008 for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex.