Monday, 30 March 2009
AstraZeneca has been informed that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) has been tentatively scheduled to meet on 9 and 10 June 2009. AstraZeneca has been advised that at its meeting, the PDAC will discuss the safety and efficacy of supplemental new drug applications (sNDAs) for SEROQUEL proposed for the acute treatment of schizophrenia in adolescents (13-17 years of age), and the acute treatment of bipolar mania in children and adolescents (10-17 years of age).
AstraZeneca fully supports the work of the FDA in conducting a full review of the potential benefits and risks of SEROQUEL in the acute treatment of schizophrenia in adolescents, the acute treatment of bipolar mania in children and adolescents.
SEROQUEL was approved in the U.S. in 1997 and is indicated for the treatment of adults for the acute manic and depressive episodes of bipolar disorder and for schizophrenia. To date, the safety of SEROQUEL has been evaluated in clinical trials with thousands of patients.
The current FDA approved indications for SEROQUEL are not scheduled to be part of the upcoming PDAC meeting.
SEROQUEL is not currently approved for use in paediatrics in any country.
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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