FDA ADVISORY COMMITTEE RECOMMENDATION ON SEROQUEL XR

FDA ADVISORY COMMITTEE RECOMMENDATION ON SEROQUEL XR SUPPLEMENTAL NEW DRUG
APPLICATIONS

On 8 April 2009, the U.S. Food and Drug Administration (FDA)
Psychopharmacologic Drugs Advisory Committee (PDAC) conducted a review
of the safety and efficacy of supplemental new drug applications (sNDA)
for SEROQUEL XR (quetiapine fumarate) extended-release tablets proposed
for the treatment of major depressive disorder (MDD) and generalised
anxiety disorder (GAD).
The Advisory Committee concluded:
-  SEROQUEL XR was shown to be effective in MDD as both monotherapy and
adjunctive therapy, and shown to be effective in GAD as monotherapy.

-  SEROQUEL XR was shown to be acceptably safe as an adjunctive
treatment for MDD.

-  SEROQUEL XR was not shown to be acceptably safe as a monotherapy for
broad treatment for MDD.

-  The committee was undecided as to whether SEROQUEL XR was shown to be
acceptably safe in certain instances as a monotherapy treatment for MDD.

-  SEROQUEL XR was not shown to be acceptably safe as a monotherapy for
the treatment of GAD.
Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca, said: “We
are pleased that the committee found SEROQUEL XR to be effective and
acceptably safe for use as adjunctive therapy for the treatment of MDD.
Although the committee recognized the effectiveness of SEROQUEL XR as
monotherapy for MDD and GAD, they had concerns around the long-term
safety profile in these new populations. We look forward to having
further discussions with the FDA regarding both sNDAs.”
The FDA frequently convenes advisory committee meetings to obtain
independent expert guidance and recommendations on clinical matters. 
While the FDA is not required to follow this guidance, the agency
usually takes the advice into consideration when rendering its final
decisions on pending applications and other public health matters.
SEROQUEL XR is not approved for the treatment of MDD and GAD. 
                                - ENDS -

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Ann-Leena Mikiver +46 70 742 88 36 (Sverige)
Neil McCrae       +44 207 304 5045  
IR-kontakter:                       
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Karl Hard         +44 207 304 5322 mob: +44 7789 654364

About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacturing and marketing of meaningful
prescription medicines and supplier for healthcare services. AstraZeneca
is one of the world's leading pharmaceutical companies with healthcare
sales of US$ 31.6 billion and is a leader in gastrointestinal,
cardiovascular, neuroscience, respiratory, oncology and infectious
disease medicines.  For more information about AstraZeneca, please
visit: www.astrazeneca.com
FDA ADVISORY COMMITTEE RECOMMENDATION ON SEROQUEL XR SUPPLEMENTAL NEW DRUG APPLICATIONS

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