`
`
`
`DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`
`
`
`
`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
`
`
`
`NDA 21-928/S-003
`
`
`Pfizer Inc
`235 East 42nd Street
`New York City, NY 10017
`
`Attention: Samantha McNamara
`
`Director, US Regulatory Affairs
`
`Dear Ms. McNamara:
`
`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.
`
`We acknowledge receipt of your email communications dated November 14 and 20, 2007.
`
`This “Changes Being Effected” supplemental new drug application provides for the following package
`insert and patient package insert labeling changes:
`
`
`• 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.
`
`
`
`
`
`
`
`• 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.
`
`• 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.
`
`• Several minor editorial changes (correction of typographical errors).
`
`
`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.
`
`The final printed labeling (FPL) must be identical to the enclosed labeling text for the package insert,
`and for the patient package insert.
`
`
`
`
`NDA 21-928/S-003
`Page 2
`
`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.
`
`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:
`
`
`
`
`
`
`
`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 Dominic Chiapperino, Regulatory Project Manager, at (301) 796-1183.
`
`
`
`MEDWATCH
`Food and Drug Administration
`5515 Security Lane
`HFD-001, Suite 5100
`Rockville, MD 20852
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Bob Rappaport, M.D.
`Director
`Division of Anesthesia, Analgesia, and
`Rheumatology Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
`
`
`
`
`
`
`Enclosure: Approved package insert and patient package insert labeling
`
`
`
`---------------------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------------------------------------------------------------------------------------------------------------
` /s/
`---------------------
`Rigoberto Roca
`11/20/2007 05:59:59 PM
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
