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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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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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`Lilya I. Donohew, Ph.D.
`Director, Worldwide Regulatory Affairs
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`NDA 021928/SLR-014, SLR-017
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`Pfizer, Inc.
`235 East 42nd Street
`Mailstop 605 6 31
`New York, NY 10017
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`Attention:
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`Dear Dr. Donohew:
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`Please refer to your supplemental new drug applications dated July 20, 2009, and January 14,
`2010, received July 20, 2009, and January 14, 2010, 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 submissions dated February 17, 2010 (S-017) and February 25,
`2010 (S-014).
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`Supplement NDA 021928/S-014 proposes conversion of the content of the currently approved
`package insert into the Physicians Labeling Rule (PLR) format as set forth under 21 CFR 201.56
`and 21 CFR 201.57.
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`We also refer to the email correspondences between FDA and Pfizer dated March 16, 2010, in
`which agreement was reached on content of the package insert in the PLR format.
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`Supplement NDA 021928/S-017 provides for a proposed modification to the approved risk
`evaluation and mitigation strategy (REMS) and includes your REMS assessment.
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`We have completed our review of these applications, as amended, and they are approved,
`effective on the date of this letter, for use as recommended in the enclosed agreed upon labeling
`text for the package insert, Medication Guide and modified REMS.
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, please submit the
`content of labeling [21 CFR 314.50(l)(1)(i)] in structured product labeling (SPL) format as
`described at http://www.fda.gov/oc/datacouncil/spl.html that is identical to the enclosed
`labeling text for the package insert and Medication Guide). For administrative purposes, please
`designate this submission, “SPL for approved NDA 21928/S-014 and S-017.
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`

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` NDA 21-928/S-014, S-017
`Page 2
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`We request that the revised labeling approved today be available on your website within 10 days
`of receipt of this letter.
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`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of
`prescribing information. This waiver applies to all future supplements containing revised
`labeling unless we notify you otherwise.
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` RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
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`The REMS for Chantix (varenicline) was originally approved on October 19, 2009. The REMS
`consists of a Medication Guide and a timetable for submission of assessments of the REMS. The
`proposed modified REMS contains a revised Medication Guide that includes a new section
`“Who should not take Chantix".
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`Your proposed modified REMS, submitted on January 14, 2010, and appended to this letter, is
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`approved. The REMS consists of the Medication Guide and the timetable for submission of
`assessments.
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`The timetable for submission of assessments will remain the same as that approved on
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`October 19, 2009.
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`There are no changes to the REMS assessment plan described in our October 19, 2009 letter.
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`If you do not submit electronically, please send 5 copies of REMS-related submissions.
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` PROMOTIONAL MATERIALS
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`All promotional materials for your drug product that include representations about your drug
`product must be promptly revised to make it consistent with the labeling changes approved in
`this supplement, including any new safety information [21 CFR 314.70(a)(4)]. The revisions to
`your promotional materials should include prominent disclosure of the important new safety
`information that appears in the revised package labeling. Within 7 days of receipt of this letter,
`submit your statement of intent to comply with 21 CFR 314.70(a)(4) to the following address or
`by facsimile at 301-847-8444:
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`In addition, as required under 21 CFR 314.81(b)(3)(i), you must submit your updated final
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`promotional materials, and the package insert(s), at the time of initial dissemination or
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`publication, accompanied by a Form FDA-2253, directly to the above address. For instruction
`on completing the Form FDA 2253, see page 2 of the Form. For more information about
`submission of promotional materials to the Division of Drug Marketing, Advertising, and
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` NDA 21-928/S-014, S-017
`Page 3
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`Communications (DDMAC), see
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`http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`LETTERS TO HEALTH CARE PROFESSIONALS
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`If you decide to issue a letter communicating important safety related information about this drug
`product (i.e., a “Dear Health Care Professional” letter), we request that you at least 24 hours
`prior to issuing the letter, an electronic copy of the letter to this NDA, to
`CDERMedWatchSafetyAlerts@fda.hhs.gov, and to the following address:
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`MedWatch
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`Food and Drug Administration
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`5600 Fishers Lane, Room 12B05
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`Rockville, MD 20857
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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, contact Ayanna Augustus, Regulatory Project Manager, at
`ayanna.augustus@fda.hhs.gov or (301) 796-3980.
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`Sincerely,
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`{See appended electronic signature page}
`
` MD, MHS
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` Lapteva,
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`Larissa
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`Deputy Director for Safety
`Division of Anesthesia and Analgesia
`Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`Enclosures
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`1. Package Insert
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`2. Medication Guide
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`3. REMS
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`

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`Application
`Type/Number
`--------------------
`NDA-21928
`NDA-21928
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`Submission
`Type/Number
`--------------------
`SUPPL-17
`SUPPL-14
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`Submitter Name
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`Product Name
`
`--------------------
`PFIZER INC
`PFIZER INC
`
`------------------------------------------
`CHANTIX
`CHANTIX
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`LARISSA LAPTEVA
`04/22/2010
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`