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

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`egg.“ s:“VICESIO‘C'
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`"3;," g DEPARTMENTOF HEALTH & HUMAN SERVICES
`
`“an,"
`
`
`Food and Drug Administration
`Rockville, MD 20857
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`PublicHealth Service
`
`NDA 22-030
`
`APPROVABLE LETTER
`
`Schwarz Biosciences
`
`Attention: Alan Blumberg, Ph.D.
`Senior Director, Global Regulatory Affairs
`PO. Box 110167
`
`Research Triangle Park, NC 27709
`
`Dear Dr. Blumberg:
`
`Please refer to your March 17, 2006 new drug application (NDA) submitted under section 505(b) of
`the Federal Food, Drug, and Cosmetic Act for fesoterodine fumarate, 4 and 8 mg extended release
`tablets.
`
`We also refer to your submissions dated May 15, 17 and 23, July 20 and 21, August 3, 9, and 31,
`' September 25, October 3, 6, and 27, November 1,16 and 22, 2006; and January 11, 2007.
`
`We completed our review of this application, as amended, and it is approvable. Before the application
`may be approved, however, it will be necessary for you to address the following:
`
`1. Pre-Approval Inspection (PAI) of your active pharmaceutical ingredient (API) manufacturing
`facility, Schwarz Pharma Ltd., located in Shannon, Ireland could not be conducted because the site has
`not been available for PAI during this review cycle, as stated in your letter, dated July 20, 2006.
`
`Satisfactory inspection of your API manufacturing facility, Schwarz Pharma Ltd., located in
`Shannon, Ireland is required before this application may be approved.
`
`2. Labeling remains unresolved.
`
`Reference is made to the revised labeling conveyed to you on January 24, 2007, that will serve
`as the basis for future discussions.
`If additional information relating to the safety or
`effectiveness of this drug becomes available, revision of the January 24, 2007 labeling may be
`required.
`
`When you respond to the above deficiencies, include a safety update as described at 21 CFR
`314.50(d)(5)(vi)(b). The safety update should include data from all non-clinical and clinical studies of
`the drug under consideration regardless of indication, dosage form, or dose level.
`
`1. Describe in detail any significant changes or findings in the safety profile.
`
`

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`.NDA 22-030
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`Page 2
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`2. When assembling the sections describing discontinuations due to adverse events, serious adverse
`events, and common adverse events, incorporate new safety data as follows:
`
`. Present new safety data from the studies for the proposed indication using the same format as the
`original NDA submission.
`0 Present tabulations of the new safety data combined with the original NDA data.
`0
`Include tables that compare frequencies of adverse events in the original NDA with the
`retabulated frequencies described in the bullet above.
`0 For indications other than the proposed indication, provide separate tables for the frequencies of
`adverse events occurring in clinical trials.
`
`3. Present a retabulation of the reasons for premature study discontinuation by incorporating the drop-
`outs from the newly completed studies. Describe any new trends or patterns identified.
`
`4. Provide case report forms and narrative summaries for each patient who died during a clinical
`study or who did not complete a study because of an adverse event. In addition, provide narrative
`summaries for serious adverse events.
`
`5. Describe any information that suggests a substantial change in the incidence of common, but less
`serious, adverse events between the new data and the original NDA data.
`
`6. Provide a summary of worldwide experience on the safety of this drug. Include an updated
`estimate of use for drug marketed in other countries.
`
`7. Provide English translations of current approved foreign labeling not previously submitted.
`
`In addition, submit three copies of the introductory promotional materials that you propose to use for
`this product. Submit all proposed materials in draft or mock-up form, not final print. Send one copy to
`this division and two copies of both the promotional materials and the package insert directly 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
`
`Within 10 days after the date of this letter, you are required to amend this application, notify us of your
`intent to file an amendment, or follow one of your other options under 21 CFR 314.110. If you do not
`follow one of these options, we will consider your lack of response a request to withdraw the
`application under 21 CFR 314.65. Any amendment should respond to all the deficiencies listed. We
`will not process a partial reply as a major amendment nor will the review clock be reactivated until all
`deficiencies have been addressed.
`
`Under 21 CFR 314.102(d), you may request a meeting or telephone conference with this division to
`discuss what steps need to be taken before the application may be approved.
`
`The drug product may not be legally marketed until you have been notified in writing that the
`application is approved.
`'
`
`

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`NDA 22—030
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`Page 3
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`If you have any questions, call Jean Makie, M.S., R.D., Sr. Regulatory Project Manager, at (301) 796-
`0952.
`-
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Julie Beitz, MD
`Director
`
`Office of Drug Evaluation 111
`Center for Drug Evaluation and Research
`
`

`

`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Julie Beitz
`
`1/25/2007 11:19:22 AM
`
`