FDA Requires Additional Data For Seroquel XR Supplemental New Drug Application

The U.S. FDA (Food and Drug Administration) has asked AstraZeneca, the makers of Seroquel XR (quetiapine fumarate), for additional information for its extended release tablets for the treatment of MDD (Major Depressive Disorder) in adult patients.

The FDA’s CRL (Complete Response Letter) was sent to AstraZeneca on 24th December. AstraZeneca says it is evaluating the contents of the letter and the proposed labeling revisions. The company says it will resume 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 United States 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.

AstraZeneca stresses that the CRL does not alter in any way the current recommendations for the treatment of patients taking Seroquel XR or Seroquel for already approved indications in schizophrenia and bipolar disorder.

AstraZeneca, in a statement to investors, says it will report on progress when appropriate.

Source – AstraZeneca

Written by Christian Nordqvist