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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:  04/30/2013
 
Trade Name:  Seroquel and Seroquel XR
 
Generic Name or Proper Name (*):  quetiapine
 
Indications Studied:  Bipolar depression
 
Label Changes Summary:  Efficacy was not established in an 8-week placebo-controlled monotherapy trial of Seroquel XR in children and adolescents 10-17 years with bipolar depression.In the same study patients treated with Seroquel XR exhibited metabolic changes, weight gain, and increases in blood pressure and heart rate. The most commonly observed adverse reactions were dizziness 7%, diarrhea 5%, fatigue 5% and nausea 5% Information on adverse reactions, clinical tria Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  AstraZeneca
 
NNPS:  FALSE'
 
Therapeutic Category:  Antipsychotic
 
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