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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:  02/22/2019
 
Trade Name:  Chantix
 
Generic Name or Proper Name (*):  varenicline
 
Indications Studied:  Aid to smoking cessation treatment
 
Label Changes Summary:  *Chantix is not recommended for use in pediatric patients 16 years or younger because its efficacy in this population was not demonstrated. *Efficacy and safety of varenicline were evaluated in a randomized, double-blind, placebo-controlled study of 312 patients aged 12 to 19 years. Results from this study showed that varenicline, at either dose studied, did not improve continuous abstinence rates at weeks 9 through 12 of treatment compared with placebo in patients 12 to 19 years. *Varenicline safety profile in this study was consistent with that observed in adult studies. *Information on pharmacokinetics.
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  PF Prism CV
 
Pediatric Exclusivity Granted Date:  11/15/2018
 
NNPS:  FALSE
 
Therapeutic Category:  Smoking cessation
 
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