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:  05/06/2019
 
Trade Name:  Sorilux
 
Generic Name or Proper Name (*):  calcipotriene
 
Indications Studied:  Topical treatment of plaque psoriasis of the scalp and body in patients 12 years and older
 
Label Changes Summary:  *Safety and effectiveness have been established in pediatric patients age 12 years and older for topical treatment of plaque psoriasis of the scalp and body. *Use of in this age group is supported by two adequate and well controlled 8-week trials in adults and adolescents 12 years and older, with additional data from an open-label safety and pharmacokinetics study. *The safety and effectiveness of in pediatric patients less than 12 years of age have not been established. *Information on adverse reactions, PK parameters, and clinical trials.
 
PREA(P):  P
 
Sponsor:  Mayne Pharma International
 
NNPS:  FALSE
 
Therapeutic Category:  Antipsoriatic, topical
 
-
-