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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021928/S-024
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Pfizer, Inc.
`235 E. 42nd Street
`New York, NY 10017
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`Attention: Lilya I. Donohew, Ph.D.
` Senior Director, Worldwide Regulatory Affairs
`
`
`Dear Dr. Donohew:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated March 16, 2011,
`received March 16, 2011, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Chantix (varenicline) Tablets 0.5 mg and 1 mg.
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`We acknowledge receipt of your amendment dated May 19, 2011.
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`This supplemental new drug application proposes new starting and continuing month packaging
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` for Chantix.
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`We have completed our review of this supplemental application, as amended. It is approved,
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` effective on the date of this letter.
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and container labels that are identical to the enclosed carton and
`immediate container labels submitted on May 19, 2011, as soon as they are available, but no
`more than 30 days after they are printed.
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`Please submit these labels electronically according to the guidance for industry titled “Providing
`Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications
`and Related Submissions Using the eCTD Specifications (June 2008).” Alternatively, you may
`submit 12 paper copies, with 6 of the copies individually mounted on heavy-weight paper or
`similar material. For administrative purposes, designate this submission “Product
`Correspondence – Final Printed Carton and Container Labels for approved
`NDA 021928/S-024.” Approval of this submission by FDA is not required before the labeling is
`used.
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`Reference ID: 2967518
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` NDA 021928/S-024
`Page 2
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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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`If you have any questions, call Ayanna Augustus, Ph.D., Regulatory Project Manager, at (301)
`796-3980.
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`Sincerely,
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` {See appended electronic signature page}
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`Bob A. Rappaport, M.D.
`Director
`
`Division of Anesthesia, Analgesia,
`and Addiction Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
`Carton and Container Labeling
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`Reference ID: 2967518
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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/
`----------------------------------------------------
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`BOB A RAPPAPORT
`06/29/2011
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`Reference ID: 2967518
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