Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Raptor Pharmaceuticals, Inc.
 
NNPS:  FALSE
 
-
-