`
`
`
`
`
`Food and Drug Administration
`
`Silver Spring, MD 20993
`
`
`
`
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`
`
` NDA 021928/S-023
`
`Reference ID: 2880005
`
`
`
` SUPPLEMENT APPROVAL
`
`Pfizer, Inc.
`235 E. 42nd Street
`New York, NY 10017
`
`Attention: Lilya I. Donohew, Ph.D.
` Director, Worldwide Regulatory Affairs
`
`
`Dear Dr. Donohew:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated December 1, 2010,
`received December 1, 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.
`
`This Changes Being Effected supplemental new drug application proposes changes to the
`ADVERSE REACTIONS/Postmarketing Experience section to include information
`describing postmarketing reports of myocardial infarction and cerebrovascular accidents
`occurring with use of Chantix (varenicline).
`
`We have completed our review of this supplemental application. 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, using the FDA
`automated drug registration and listing system (eLIST), the content of labeling
`[21 CFR 314.50(l)] in structured product labeling (SPL) format, as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is
`identical to the enclosed labeling text for the package insert and Medication Guide and include
`the labeling changes proposed in any pending “Changes Being Effected” (CBE) supplements and
`any 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
`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 for this NDA, including CBE
`supplements for which FDA has not yet issued an action letter, with the content of labeling
`
`

`

`
`
` NDA 021928/S-023
`Page 2
`
`[21 CFR 314.50(l)(1)(i)] in MS Word format that includes the changes approved in this
`supplemental application.
`
`
`LETTERS TO HEALTH CARE PROFESSIONALS
`
`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 submit, at least
`24 hours prior to issuing the letter, an electronic copy of the letter to this NDA to the following
`address:
`
`
`
`MedWatch Program
`
`Office of Special Health Issues
`
`
`Food and Drug Administration
`
`10903 New Hampshire Ave
`
`
`Building 32, Mail Stop 5353
`
`Silver Spring, MD 20993
`
`
`
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call Ayanna Augustus, Ph.D., Regulatory Health Project Manager, at
`(301) 796-3980.
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`Larissa Lapteva, M.D.
`Deputy Director for Safety
`Division of Anesthesia and Analgesia Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
`
`
`ENCLOSURE(S):
`Package Insert
`
`Medication Guide
`
`Reference ID: 2880005
`
`

`

`---------------------------------------------------------------------------------------------------------
`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
`12/17/2010
`
`Reference ID: 2880005
`
`