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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:
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
BPCA(B):
B
Sponsor:
Roche
Pediatric Exclusivity Granted Date:
09/12/2003
NNPS:
FALSE'
Therapeutic Category:
Obesity management
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