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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: oHyperglycemia - a statistically significantly greater mean change in fasting glucose levels compared to placebo oHyperlipidemia  statistically significant increases compared to placebo in fasting triglycerides, fasting total cholesterol and fasting LDL cholesterol oWeight 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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