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December 6, 2009
FDA Approves Seroquel for Bipolar Children and Adolescents
The U.S. Food and Drug Administration (FDA) announced Friday that Seroquel (quetiapine fumarate) has been approved for the acute treatment of manic episodes associated with bipolar I disorder in children and adolescents (10-17 years of age), both as monotherapy (single-drug therapy) and as an adjunct to Lithium or Depakote (valproic acid). The FDA also approved Seroquel for the treatment of schizophrenia in adolescents (13-17 years of age) as monotherapy.
"Bipolar mania and schizophrenia in children and adolescents, while rare, are serious disorders and it is important to have treatments approved for use in this patient population," said Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca, the firm that manufactures Seroquel, part of class of drugs known as atypical antipsychotics. "These new indications for Seroquel provide another FDA-approved option for treating pediatric patients suffering from these severe mental illnesses."
The FDA also approved once-daily Seroquel XR (Extended Release) Tablets as adjunctive (add-on) treatment to antidepressants in adults with Major Depressive Disorder on Friday. Seroquel XR is reportedly the only medication in its class approved by the FDA to treat both major depressive disorder as adjunctive therapy and acute depressive episodes associated with bipolar disorder as monotherapy, according to AstraZeneca.
Source: AstraZeneca news releases
Posted by Michael Lane at December 6, 2009 9:31 PM
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