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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

About AstraZeneca
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.

AstraZeneca Contacts:

Media Enquiries:
Neil McCrae +44 207 304 5045 (24 hours)
Chris Sampson +44 20 7304 5130 (24 hours)
Sarah Lindgreen +44 20 7304 5033 (24 hours)

Investor Enquiries UK:
Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032
Mina Blair +44 20 7304 5084 mob: +44 7718 581021
Karl Hard +44 207 304 5322 mob: +44 7789 654364

Investor Enquiries US:
Ed Seage +1 302 886 4065 mob: +1 302 373 1361
Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043
Peter Vozzo (MedImmune) +1 301 398 4358 mob: +1 301 252 7518

Posted: December 2008

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