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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:  11/09/2011
 
Trade Name:  Chantix
 
Generic Name or Proper Name (*):  varenicline
 
Indications Studied:  Smoking cessation
 
Label Changes Summary:  Safety and effectiveness of Chantix in pediatric patients have not been established; Chantix is not recommended for use in patients < 18 years of ageInformation on single and multiple-dose pharmacokinetics of varenicline have been investigated in pediatric patients 12 - 17 years Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Pfizer
 
NNPS:  FALSE'
 
Therapeutic Category:  Smoking cessation
 
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