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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:  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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