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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.
Sponsor:  Mayne Pharma, Inc.
Therapeutic Category:  Vitamin D analog