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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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` NDA 021928/S-048
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`SUPPLEMENT APPROVAL
`FULFILLMENT OF POSTMARKETING REQUIREMENT
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`PF Prism C V
`c/o Pfizer, Inc
`235 East 42nd Street
`New York, NY 10017-5755
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`
`Attention: Mojgan Sadrarhami, Pharm D
`Senior Director, Worldwide Regulatory Strategy
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`
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`Dear Dr. Sadrarhami:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received August 22,
`2018, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA), for CHANTIX (varenicline) tablets.
`
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`This Prior Approval supplemental new drug application provides for changes to Sections 8.4 USE
`IN SPECIFIC POPULATIONS, and 12.3 CLINICAL PHARMACOLOGY based on studies
`conducted to fulfill your Pediatric Written Request (PWR), and Pediatric Research Equity Act
`(PREA) Postmarketing Requirement.
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`APPROVAL & LABELING
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`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
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`text.
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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, submit the content of
`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA automated
`drug registration and listing system (eLIST), as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content of
`labeling must be identical to the enclosed labeling (text for the Prescribing Information and
`Medication Guide), with the addition of any labeling changes in pending “Changes Being Effected”
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`(CBE) supplements, as well as annual reportable changes not included in the enclosed labeling.
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`Information on submitting SPL files using eList may be found in the guidance for industry titled
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`Reference ID: 4394346
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`

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`NDA 021928/S-048
`Page 2
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`“SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM
`072392.pdf.
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` The SPL will be accessible from publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications that include 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 314.50(l)(1)(i)] in Microsoft Word format, that includes the changes
`approved in this supplemental application, as well as annual reportable changes. To facilitate review
`of your submission(s), 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).
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`REQUIRED PEDIATRIC ASSESSMENTS
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`We note that you have fulfilled the pediatric study requirements for all relevant pediatric age groups
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`for this application.
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`FULFILLMENT OF POSTMARKETING REQUIREMENT
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`We have received your submission dated August 22, 2018, reporting on and containing the final
`report for the following postmarketing requirement listed in the May 10, 2006, approval letter:
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`1544-2 To conduct a study to determine whether varenicline, as part of an overall smoking
`cessation program, is effective in achieving and maintaining smoking cessation in
`tobacco-addicted adolescents, ages 12 through 16, inclusive, to determine a safe and
`effective dose, and to document the ability of treating physicians to select appropriate
`patients. You will need to develop a means for determining reliable criteria for appropriate
`patient selection of tobacco-addicted teens so that teenage smokers who are not addicted
`will not be recruited, and so that labeling can convey these criteria to physicians who may
`wish to use the drug in adolescents.
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`We have reviewed your submissions and conclude that the above requirement has been fulfilled.
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`This completes all of your postmarketing requirements and postmarketing commitments
`acknowledged in our May 10, 2006, approval letter.
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`PROMOTIONAL MATERIALS
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`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 Prescribing
`Information to:
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`Reference ID: 4394346
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`

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`NDA 021928/S-048
`Page 3
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`OPDP Regulatory Project Manager
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion (OPDP)
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`Alternatively, you may submit a request for advisory comments electronically in eCTD format. For
`more information about submitting promotional materials in eCTD format, see the draft Guidance
`for Industry (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM
`443702.pdf ).
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`You must submit final promotional materials and Prescribing Information, accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form FDA
`2253 is available at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`more information about submission of promotional materials to the Office of Prescription Drug
`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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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 Kimberly Compton, RPh, RAC, Sr Regulatory Project Manager, at
`301-796-1191.
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`Sincerely,
`
`{See appended electronic signature page}
`
`Rigoberto Roca, MD
`Deputy Director
`Division of Anesthesia, Analgesia, and
`Addiction Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`ENCLOSURES:
`Content of Labeling
`Prescribing Information
`Medication Guide
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`Reference ID: 4394346
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`

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`Signature Page 1 of 1
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`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
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`/s/
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`RIGOBERTO A ROCA
`02/22/2019 09:22:47 AM
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`Reference ID: 4394346
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