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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 age* Information 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
Therapeutic Category:  Smoking cessation