AstraZeneca 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 formulation of SEROQUEL (quetiapine fumarate), was approved in the U.S. 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. The CRL does not change the current recommendations for the treatment of patients taking SEROQUEL XR or SEROQUEL for approved indications in schizophrenia and bipolar disorder.
An update to AstraZeneca investors on progress will be provided when appropriate.
Source: AstraZeneca, USA