FDA Complete Response Letter for Seroquel XR sNDA
AstraZeneca Receives FDA Complete Response Letter On Seroquel XR For Generalised Anxiety Disorder
LONDON, Feb. 27, 2009--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 (sNDA) for Seroquel XR (quetiapine fumarate) Extended Release Tablets for the treatment of Generalised Anxiety Disorder (GAD) in adult patients.
AstraZeneca is evaluating the contents of the CRL and the proposed labelling revisions. AstraZeneca announced on 25 February 2009 that the company had been advised by the FDA that the Psychopharmacologic Drugs Advisory Committee (PDAC) is tentatively scheduled to meet on 8 April 2009 to discuss the safety and efficacy of sNDAs for Seroquel XR proposed for the treatment of major depressive disorder (MDD) and GAD.
An update to AstraZeneca investors will be provided when appropriate.
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.
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.
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Posted: February 2009