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