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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:  05/10/2006
 
Trade Name:  Sandostatin LAR
 
Generic Name or Proper Name (*):  octreotide
 
Indications Studied:  Weight loss due to hypothalamic obesity from cranial insult
 
Label Changes Summary:  A randomized double-blind, placebo-controlled study in 60 patients aged 6 17 years with hypothalamic obesity from cranial insult did not demonstrate efficacy and safety of octreotide as a weight loss agent; Mean BMI increased 0.1 kg/m2 in drug treated patients compared to 0.0 kg/m2 in control-treated patients No unexpected AEs were observed; However, the incidence of new cholelithiasis in this pediatric population (33%) was higher than that seen in adult indications Information on PK parameters and AEs
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Novartis
 
Pediatric Exclusivity Granted Date:  01/12/2006
 
NNPS:  FALSE'
 
Therapeutic Category:  Endocrine agent
 
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