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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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