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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:  01/25/2010
 
Trade Name:  Sandostatin and Sandostatin LAR
 
Generic Name or Proper Name (*):  octreotide
 
Indications Studied:  Weight loss due to hypothalamic obesity from cranial insult
 
Label Changes Summary:  Post-marketing reports of hypoxia, necrotizing enterocolitis, and death in children added to Pediatric Use. The relationship of these events to octreotide has not been established. Pediatric Use subsection of Sandostatin labeling harmonized with Sandostatin LAR labeling
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Novartis
 
Pediatric Exclusivity Granted Date:  01/12/2006
 
NNPS:  TRUE'
 
Therapeutic Category:  Endocrine agent
 
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