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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:  12/23/2014
 
Trade Name:  Taclonex
 
Generic Name or Proper Name (*):  calcipotriene/ betamethasone dipropionate
 
Indications Studied:  Psoriasis vulgaris
 
Label Changes Summary:  *Extended the indication for psoriasis down to pediatric patients 12 to 17 years , based on adequate and well controlled studies in adults supported by a 4 week safety study in 33 patients 12 years and older. *Patients with plaque psoriasis involving 5-30% of the body surface area were treated with Taclonex Ointment for 4 weeks up to a maximum of 55.8 g per week. *Maximum weekly dose established (60 g per week)
 
Product Labeling:  Labeling  Opens a new window
 
Sponsor:  LEO Pharma
 
Therapeutic Category:  Vitamin D analog
 
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