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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:  08/14/2008
 
Trade Name:  Zyprexa
 
Generic Name or Proper Name (*):  olanzapine
 
Indications Studied:  schizophrenia; bipolar disorder
 
Label Changes Summary:  * Safety and effectiveness have not been established for patients less than 18 years of age * In an analysis of placebo-controlled olanzapine monotherapy studies of adolescent patients, including those with schizophrenia or bipolar disorder, olanzapine was associated with: o Hyperglycemia - a statistically significantly greater mean change in fasting glucose levels compared to placebo o Hyperlipidemia  statistically significant increases compared to placebo in fasting triglycerides, fasting total cholesterol and fasting LDL cholesterol o Weight gain  olanzapine treated patients gained an average of 4.6 kg, compared to an average of 0.3 kg in placebo-treated patients with a median exposure of 3 weeks; Average weight gain during long-term therapy was 7.4 kg
 
BPCA(B):  B
 
Sponsor:  Lilly
 
Pediatric Exclusivity Granted Date:  01/10/2007
 
NNPS:  FALSE
 
Therapeutic Category:  Antipsychotic
 
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