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SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia
Date:11/16/2007

n prescribed to millions of patients worldwide. It is approved in 88 countries for the treatment of schizophrenia, in 77 countries for the treatment of bipolar mania, and in 11 countries including the U.S. for the treatment of bipolar depression. SEROQUEL XR was launched for the treatment of schizophrenia in the US in 2007, and clinical development programs and regulatory filings are planned for a number of other indications.

Important Safety Information for SEROQUEL and SEROQUEL XR

SEROQUEL XR is indicated for the acute and maintenance treatment of schizophrenia. SEROQUEL is indicated for the treatment of depressive episodes in bipolar disorder; acute manic episodes in bipolar I disorder, as either monotherapy or adjunct therapy to lithium or divalproex; and schizophrenia. Patients should be periodically reassessed to determine the need for treatment beyond the acute response.

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death, compared to placebo (4.5% vs 2.6%, respectively). SEROQUEL and SEROQUEL XR are not approved for the treatment of patients with dementia-related psychosis. (See Boxed Warning.)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies of major depressive disorder and other psychiatric disorders. Patients of all ages started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SEROQUEL and SEROQUEL XR are not approved for use in patients under the age of 18 years. SEROQUEL XR is not approved for the treatment of depression, however SEROQUEL is approved for the treatment of bipolar depression. (See Boxed Warning.)

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SOURCE AstraZeneca
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