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:  03/11/2019
 
Trade Name:  Dupixent
 
Generic Name or Proper Name (*):  dupilumab
 
Indications Studied:  Moderate-to-severe atopic dermatitis
 
Label Changes Summary:  *Safety and efficacy have been established in pediatric patients 12 years and older. *A total of 251 adolescents ages 12 to 17 years old with moderate-to-severe atopic dermatitis were enrolled in the clinical trial. *Safety and efficacy in pediatric patients less than12 years with atopic dermatitis have not been established. *The safety profile in pediatric patients is similar to that in adults. *Information on adverse reactions, PK parameters and clinical trial. *Postmarketing study.
 
Product Labeling:  [INVALID]  Opens a new window
 
PREA(P):  P
 
Sponsor:  Regeneron Pharmaceuticals
 
NNPS:  FALSE
 
Therapeutic Category:  Monoclonal antibody
 
-
-