Complete Response Letter for Seroquel XR sNDA
AstraZeneca Receives FDA Complete Response Letter on Seroquel XR for Major Depressive Disorder
LONDON, 24 December 2008 -- 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 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.
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24 December 2008
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information visit www.astrazeneca.com.
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Posted: December 2008