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