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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:  11/05/2019
 
Trade Name:  Sorilux
 
Generic Name or Proper Name (*):  calcipotriene
 
Indications Studied:  Topical treatment of plaque psoriasis of the scalp and body in pediatric patients 4 years and older
 
Label Changes Summary:  *Expanded the indication down to patients 4 years of age and older; previously approved for use in 12 years and older. *Safety and effectiveness in pediatric patients less than 4 years have not been established. *Information on PK, and clinical trial. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  Mayne Pharma, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Vitamin D analog
 
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