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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
Sponsor:  Novartis
Pediatric Exclusivity Granted Date:  01/12/2006
Therapeutic Category:  Endocrine agent