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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:  03/22/2007
 
Trade Name:  Aldara
 
Generic Name or Proper Name (*):  imiquimod
 
Indications Studied:  Molluscum contagiosum
 
Label Changes Summary:  * Efficacy in patients 2  12 years for the treatment of molluscum contagiosum was not demonstrated in two clinical trials in 702 patients * Information on clinical studies and AEs
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Graceway Pharmaceuticals
 
Pediatric Exclusivity Granted Date:  12/13/2006
 
NNPS:  FALSE
 
Therapeutic Category:  Topical
 
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