`
`NDA 021928/S—030
`
`Pfizer, Inc.
`235 E. 42nd Street
`
`New York, NY 10017
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`SUPPLENIENT APPROVAL
`
`Attention:
`
`Lilya I. Donohew, PhD
`Senior Director, Worldwide Regulatory Affairs
`
`Dear Dr. Donohew:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated April 19, 2012, received
`April 19, 2012, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for Chantix (varenicline) Tablets; 0.5 mg and 1 mg.
`
`We acknowledge receipt of your amendments dated May 24, June 7, July 30, October 24, and
`December 17, 2012, and January 17, 2013.
`
`This Prior Approval supplemental new drug application proposes revisions to the
`HIGHLIGHTS, WARNINGS AND PRECAUTIONS/Neuropsychiatric Symptoms and
`‘- Suicidality, and ADVERSE REACTIONS/Clinical Trials Experiences sections of the Package
`Insert to include information on the safety and tolerability of Chantix in patients with stable
`schizophrenia or schizoaffective disorder.
`
`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed—upon labeling
`text.
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
`labeling [21 CFR 3 1450(1)] in structured product labeling (SPL) format using the FDA
`automated drug registration and listing system (eLIST), as described at
`http://wwwfda.gov/ForIndustry/DataStandards/StructuredProductLabeling/defaulthtm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert and Medication
`Guide), with the addition of any labeling changes in pending “Changes Being Effected” (CBE)
`supplements, as well as annual reportable changes not included in the enclosed labeling.
`
`Information on submitting SPL files using eList may be found in the guidance for industry titled
`“SPL Standard for Content of Labeling Technical Qs and As at
`
`Reference ID: 3263449
`Reference ID: 3263449
`
`
`
`
`
`NDA 021928/S-030
`
`Page 2
`
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
`
`The SPL will be accessible from publicly available labeling repositories.
`
`Also within 14 days, amend all pending supplemental applications that includes labeling changes
`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
`with the content of labeling [21 CFR 3 14.50(1)(1)(i)] in MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
`annotate each change. To facilitate review of your submission, provide a highlighted or marked-
`up copy that shows all changes, as well as a clean Microsoft Word version. The marked—up copy
`should provide appropriate annotations, including supplement number(s) and annual report
`date(s).
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit the following, in triplicate, ( 1) a cover letter requesting advisory
`comments, (2) the proposed materials in draft or mock—up form with annotated references, and
`(3) the package insert(s) to:
`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion (OPDP)
`5901—B Ammendale Road
`
`Beltsville, MD 20705-1266
`
`You must submit final promotional materials and package insert(s), accompanied by a Form
`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
`FDA 2253 is available at http://wwwfda.gov/opacom/morechoices/fdaforms/cder.html;
`instructions are provided on page 2 of the form. For more information about submission of
`promotional materials to the Office of Prescription Drug Promotion (OPDP), see
`http://wwwfda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`Reference ID: 3263449
`Reference ID: 3263449
`
`
`
`
`
`NDA 021928/8-030
`
`Page 3
`
`If you have any questions, contact Ayanna Augustus, Ph.D., Regulatory Project Manager, at
`ayannaaugustus@fda.hhs.gov or (301) 796-3980.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Rigoberto Roca, MD.
`Deputy Director
`Division of Anesthesia, Analgesia,
`and Addiction Products
`
`Office of Drug Evaluation 11
`Center for Drug Evaluation and Research
`
`ENCLOSURE(S):
`Content of Labeling
`
`
`
`Reference ID: 3263449
`Reference ID: 3263449
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`RIGOBERTO A ROCA
`02/19/2013
`
`Reference ID: 3263449
`
`
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