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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 021928/S-042
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Pfizer, Inc.
`235 E. 42nd Street
`New York, NY 10017
`
`Attention:
`
`Lilya I. Donohew, PhD
`Senior Director, Worldwide Regulatory Affairs
`
`
`Dear Dr. Donohew:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received January
`12, 2017, submitted under section 505(b)of the Federal Food, Drug, and Cosmetic Act (FDCA)
`for Chantix (varenicline) Tablets; 0.5 mg and 1 mg.
`
`This “Prior Approval supplemental new drug application proposes revisions to the currently
`approved 4-week trade packaging labeling (Starting and Continuing Packs) for Chantix.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application. It is approved, effective on the
`date of this letter.
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`We acknowledge your January 12, 2017, submission containing final printed carton and
`container labels.
`
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`Reference ID: 4166685
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`NDA 021928/S-042
`Page 2
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`If you have any questions, contact Priyanka Kumar, Regulatory Project Manager, at 240 402-
`(3722).
`
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`Sincerely,
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`{See appended electronic signature page}
`
`Sharon Hertz, MD
`Director
`Division of Anesthesia, Analgesia,
` and Addiction Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`
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`ENCLOSURE:
`Carton and Container Labeling
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`Reference ID: 4166685
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`
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`SHARON H HERTZ
`10/16/2017
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`Reference ID: 4166685
`
`
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