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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:  12/04/2009
 
Trade Name:  Zyprexa
 
Generic Name or Proper Name (*):  olanzapine
 
Indications Studied:  Treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17
 
Label Changes Summary:  * Extended schizophrenia and manic or mixed episodes of bipolar I disorder indications from adults to adolescents 1317 years of age * Safety and effectiveness in children < 13 years of age have not been established * Recommended starting dose for adolescents is lower than that for adults * Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels * Information on dosing, adverse reactions, pharmacokinetics, clinical studies
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Lilly
 
Pediatric Exclusivity Granted Date:  01/10/2007
 
NNPS:  TRUE
 
Therapeutic Category:  Antipsychotic
 
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