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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:  12/12/2003
 
Trade Name:  Xenical
 
Generic Name or Proper Name (*):  orlistat
 
Indications Studied:  Obesity management
 
Label Changes Summary:  * Use in 12-16 year olds is supported by studies in adults with additional data from a 54 week safety and efficacy study in obese adolescent patients. * Since orlistat can reduce absorption of fat soluble vitamins, all patients should take a daily multivitamin supplement containing fat soluble vitamins. * Adverse event profile in adolescent patients was similar to that seen in adults
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Roche
 
Pediatric Exclusivity Granted Date:  09/12/2003
 
NNPS:  FALSE
 
Therapeutic Category:  Obesity management
 
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