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:  10/13/2017
 
Trade Name:  Stelara
 
Generic Name or Proper Name (*):  ustekinumab
 
Indications Studied:  Psoriasis treatment of adolescent patients ages 12-17 years
 
Label Changes Summary:  *Safety and effectiveness of have been established in pediatric subjects 12 to 17 years old with moderate to severe plaque psoriasis. Use of in this age group is supported by evidence from a multicenter, randomized, 60-week trial that included a 12-week, double-blind, placebo-controlled, parallel-group portion, in 110 pediatric subjects 12 years and older. *Safety and effectiveness for pediatric patients less than 12 years of age have not been established. *Adverse reactions observed in 12-17 years were similar to adults. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study
 
PREA(P):  P
 
Sponsor:  Janssen
 
NNPS:  FALSE
 
Therapeutic Category:  Monoclonal antibody
 
-
-