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New Pediatric Labeling Information Database - Detail
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Pediatrics
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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