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`DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
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`NDA 21-928/S-003
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`Pfizer Inc
`235 East 42nd Street
`New York City, NY 10017
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`Attention: Samantha McNamara
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`Director, US Regulatory Affairs
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`Dear Ms. McNamara:
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`Please refer to your supplemental new drug application dated May 9, 2007, received May 9, 2007,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Chantix (varenicline)
`Tablets.
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`We acknowledge receipt of your email communications dated November 14 and 20, 2007.
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`This “Changes Being Effected” supplemental new drug application provides for the following package
`insert and patient package insert labeling changes:
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`• Modification of the patient package insert to address possible drug adverse effects related to
`sleep and dreaming disturbance, depression, agitation, suicidal thoughts, and problems with
`driving or operating machinery when beginning treatment with varenicline to attempt to quit
`smoking.
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`• Modification of the package insert’s PRECAUTIONS, Information for Patients section to
`address possible adverse drug effects relating to driving or operating machinery when
`beginning treatment with varenicline to attempt to quit smoking.
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`• Modification to the ADVERSE REACTIONS section to address the potential for newly
`emergent psychiatric illness and the potential for exacerbation of underlying psychiatric illness
`that may occur following treatment with varenicline to attempt to quit smoking.
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`• Several minor editorial changes (correction of typographical errors).
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`We have completed our review of this application, as amended, and it is approved, effective on the
`date of this letter, for use as recommended in the enclosed agreed-upon labeling text.
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`The final printed labeling (FPL) must be identical to the enclosed labeling text for the package insert,
`and for the patient package insert.
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`NDA 21-928/S-003
`Page 2
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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)] 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 patient package insert. Upon receipt, we will transmit that version to the National
`Library of Medicine for public dissemination. For administrative purposes, please designate this
`submission, “SPL for approved NDA 21-928/S-003 " Approval of this submission by FDA is not
`required before the labeling is used.
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`If you issue a letter communicating important information about this drug product (i.e., a “Dear Health
`Care Professional” letter), we request that you submit a copy of the letter to this NDA and a copy to
`the following address:
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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 Dominic Chiapperino, Regulatory Project Manager, at (301) 796-1183.
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`MEDWATCH
`Food and Drug Administration
`5515 Security Lane
`HFD-001, Suite 5100
`Rockville, MD 20852
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`Sincerely,
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`{See appended electronic signature page}
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`Bob Rappaport, M.D.
`Director
`Division of Anesthesia, Analgesia, and
`Rheumatology Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`Enclosure: Approved package insert and patient package insert labeling
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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.
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` /s/
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`Rigoberto Roca
`11/20/2007 05:59:59 PM
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