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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:  07/30/2019
 
Trade Name:  Enstilar Foam
 
Generic Name or Proper Name (*):  calcipotriene and betamethasone dipropionate
 
Indications Studied:  Topical treatment of plaque psoriasis in patients 12 years and older
 
Label Changes Summary:  *Safety and effectiveness for the treatment of plaque psoriasis of the scalp and body have been established in pediatric patients age 12 to 17 years. *Use for this indication is supported by evidence from adequate and well-controlled trials in adults and from three uncontrolled trials in 216 adolescents. *After 4 weeks of once daily treatment, HPA axis suppression was observed in 3% of adolescents with psoriasis of the scalp and 16% of adolescents with psoriasis of the scalp and body. *Safety and effectiveness in pediatric patients less than 12 years have not been established. *Information on safety, adverse reactions, and pharmacodynamics. *Postmarketing study.
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  LEO Pharm A/S
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory, topical
 
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