CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`APPLICA TION NUMBER:
`
`22-030
`
`APPROVAL LETTER
`
`

`

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`Food and Drug Administration
`Rockville, MD 20857
`
`NDA 22-030
`
`Pfizer, Inc
`Attention: Alan McEmber
`
`Director, Worldwide Regulatory
`235 42nd Street
`
`New York, NY 10017
`
`Dear Mr. McEmber:
`
`Please refer to your new drug application (NDA) dated March 17, 2006, received March 27,
`2006, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Toviaz
`(fesoterodine fiJmarate) Tablets, 4 mg and 8 mg.
`
`We acknowledge receipt of your submissions dated May 1, May 19, June 18, July 17, August 20,
`and October 7, 2008.
`
`The May 1, 2008, submission constituted a complete response to our January 25, 2007, action
`letter.
`
`' This new drug application provides for the use of Toviaz (fesoterodine fumarate) Tablets, 4 mg
`and 8 mg, for the treatment of overactive bladder.
`
`We have completed our review of this application, as amended. It is approved, effective on the
`date of this letter, for use as recommended in the content of labeling [21 CFR 314.50(1)] in
`structured product labeling (SPL) format submitted on October 20, 2008.
`
`Your application for Toviaz was not referred to an FDA advisory committee because your
`product is a member of the class of antimuscarinic products used for the treatment of overactive
`bladder, including previously approved products, and your product did not pose unique concerns
`beyond those applicable to other members of this class.
`
`

`

`NDA 22—030
`
`Page 2
`
`CARTON AND IMMEDIATE CONTAINER LABELS
`
`Submit final printed carton and container labels that are identical to those submitted on October
`17, 2008, as soon as they are available, but no more than 30 days after they are printed. Please
`submit these labels electronically according to the guidance for industry titled Providing
`Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications
`and Related Submissions Using the eCTD Specifications (October 2005). Alternatively, you may
`submit 12 paper copies, with 6 of the copies individually mounted on heavy-weight paper or
`similar material. For administrative purposes, designate this submission “Final Printed Carton
`and Container Labels for approved NDA 22-030.” Approval of this submission by FDA is
`not required before the labeling is used.
`
`Marketing the product with Final Product Labeling (FPL) that is not identical to the approved
`labeling text may render the product misbranded and an unapproved new drug.
`
`REQUIRED PEDIATRIC ASSESSIVIENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 3550), all applications for new
`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
`administration are required to contain an assessment of the safety and effectiveness of the
`product for the claimed indication in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
`
`We are waiving the pediatric study requirement for ages 0 months to 5 years, 11 months, because
`necessary studies are impossible or highly impracticable. Thisis because study endpoints are
`difficult to evaluate1n this age group.
`
`We are deferring submission of your pediatric study for ages 6 to 16 years, 11 months, for this
`application because this product is ready for approval for use in adults and the pediatric study has
`not been completed.
`
`Your deferred pediatric study required by section 505B(a) of the Federal Food, Drug, and
`Cosmetic Act is a required postmarketing study. The status of this postmarketing study must be
`reported annually according to 21 CFR 314.81 and section 505B(a)(3)(B) of the Federal Food,
`Drug, and Cosmetic Act. This required study is listed below.
`
`1. Deferred pediatric study under PREA for the treatment of overactive bladder in the
`' subgroup of pediatric patients with neurologic disease ages 6 to 16 years, 11 months.
`
`Final Report Submission: January 31, 2012.
`
`Submit the final study report to this NDA. For administrative purposes, all submissions related to
`this required pediatric postmarketing study must be clearly designated “Required Pediatric
`Assessment.”
`
`

`

`NDA 22-030
`
`Page 3
`
`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 inserts
`to:
`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
`
`Beltsville, MD 20705-1266
`
`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`package inserts, 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
`information about submission of promotional materials to the Division of Drug Marketing,
`Advertising, and Communications (DDMAC), see www.fda.gov/cder/ddmac.
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA (21
`CFR 314.80 and 314.81).
`
`LETTERS TO HEALTH CARE PROFESSIONALS
`
`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
`
`Food and Drug Administration
`Suite 12B05
`5600 Fishers Lane
`
`Rockville, MD 20857
`
`MEDWATCH—TO-MANUFACTURER PROGRAM
`
`The MedWatch-to-Manufacturer Program provides manufacturers with copies of serious adverse
`event reports that are received directly by the FDA. New molecular entities and important new
`biologics qualify for inclusion for three years after approval. Your firm is eligible to receive
`copies of reports for this product. To participate in the program, please see the enrollment
`instructions and program description details at www.fda.gov/medwatch/report/mmphtm.
`
`

`

`NDA 22—030
`
`Page 4
`
`If you have any questions, call Celia Peacock, MPH, RD, Regulatory Project Manager, at (301)
`796-4154.
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Julie Beitz, MD.
`Director
`
`’
`Office of Drug Evaluation 111
`Center for Drug Evaluation and Research
`
`Enclosure (PI, PPI, and Carton and Immediate Container Labels)
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Julie Beiti
`10/31/2008 10:46:57 AM
`
`