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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:
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
BPCA(B):
B
Sponsor:
Novartis
Pediatric Exclusivity Granted Date:
01/12/2006
NNPS:
FALSE'
Therapeutic Category:
Endocrine agent
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