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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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` SUPPLEMENT APPROVAL
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`NDA 022030/S-007
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`Pfizer Global Research and Development
`Attention: Ursula Campbell
`Senior Director, Worldwide Regulatory Strategy
`235 East 42nd Street
`New York, NY 10017
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`Dear Ms. Campbell:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received
`September 23, 2010, submitted under section 505(b) of the Federal Food, Drug and Cosmetic Act
`(FDCA) for Toviaz® (fesoterodine fumarate) extended release tablets.
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`We also refer to your submission dated December 21, 2010, wherein you submitted a revised
`labeling for TOVIAZ, incorporating the changes requested in the Complete Response letter issued
`on November 18, 2010. Additionally, you also requested some minor revisions to the labeling.
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`This Prior Approval supplemental new drug application provides for the addition of information
`regarding angioedema to the WARNINGS and PRECAUTIONS section, and to the Information
`for Patients in the PATIENT COUNSELING INFORMATION of the TOVIAZ labeling.
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`CONTENT OF LABELING
`We have completed our review of this application. 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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`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)(1)(i)] 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). For administrative purposes, please designate this submission “SPL for approved
`NDA 22030/S-007.”
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`PROMOTIONAL MATERIALS
`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the proposed
`materials in draft or mock-up form with annotated references, and the package insert to:
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`Reference ID: 2903591
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`

`

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` NDA 022030/S-007
`Page 2
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`Food and Drug Administration
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`Center for Drug Evaluation and Research
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`Division of Drug Marketing, Advertising, and Communications
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`package insert(s), at the time of initial dissemination or publication, accompanied by a Form FDA
`2253. For instruction on completing the Form FDA 2253, see page 2 of the Form. For more
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`information about submission of promotional materials to the Division of Drug Marketing,
`Advertising, and Communications (DDMAC), see
`http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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`LETTERS TO HEALTH CARE PROFESSIONALS
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`If you 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 an electronic copy of the
`letter to both this NDA and to the following address:
`MedWatch
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`Food and Drug Administration
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`5600 Fishers Lane, Room 12B05
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`Rockville, MD 20857
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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 Eufrecina DeGuia, Senior Regulatory Health Project Manager, at
`(301) 796-0081.
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`Sincerely,
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`{See appended electronic signature page}
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`
`George Benson, M.D.
`Deputy Director
`Division of Reproductive and Urologic Products
`Office of Drug Evaluation III
`Center for Drug Evaluation and Research
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`Enclosure:
`Content of Labeling
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`Reference ID: 2903591
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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.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`GEORGE S BENSON
`02/10/2011
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`Reference ID: 2903591
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