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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:
12/22/2017
Trade Name:
Procysbi
Generic Name or Proper Name (*):
cysteamine bitartrate
Indications Studied:
Treatment-naïve nephropathic cystinosis patients 1 year and older
Label Changes Summary:
*Expanded the indication to patients age 1 year and older; previously approved in 2 years and older. * Safety and effectiveness in pediatric patients under 1 years of age have not been established. *Adverse reactions in pediatric patients were similar to those in adults. *Information on dosing, PK parameters, and clinical trial.
PREA(P):
P
Sponsor:
Horizon Pharma
Pediatric Exclusivity Granted Date:
12/12/2017
NNPS:
FALSE
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