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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  12/02/2009
Trade Name:  Seroquel
Generic Name or Proper Name (*):  quetiapine
Indications Studied:  Treatment of schizophrenia in adolescents 13 to 17 years of age and the treatment of bipolar mania in children and adolescents 10 to 17 years of age
Label Changes Summary:  * Extended schizophrenia indication from adults to adolescents 1317 years of age; extended bipolar mania indication from adults to children and adolescents 10-17 years of age * Safety and effectiveness in children < 13 years of age with schizophrenia have not been established; safety and effectiveness in children < 10 years of age with bipolar mania have not been established * Most adverse reactions in pediatric clinical trials were similar to those observed in adults and included somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, and weight increase. However, increases in blood pressure and potentially clinically significant increases in heart rate (> 110 bpm) occurred in children and adolescents and did not occur in adults. * Information on dosing, adverse reactions, pharmacokinetics, and clinical studies
Product Labeling:  Labeling  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  AstraZeneca
Pediatric Exclusivity Granted Date:  01/23/2009
Therapeutic Category:  Antipsychotic