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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:
08/14/2015
Trade Name:
Procysbi
Generic Name or Proper Name (*):
cysteamine bitartrate
Indications Studied:
Treatment of nephropathic cystinosis in pediatric patients 2 years of age and older
Label Changes Summary:
*Expanded indication to pediatric patients down to 2 years; previously approved in 6 years and older. *Safety and effectiveness in pediatric patients under 2 years of age have not been established. *Information on adding capsule contents to foods and liquids. *Information on dosing, and clinical trial extension
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Raptor Pharmaceuticals, Inc.
NNPS:
FALSE
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