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` NDA 022030/S-019
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` SUPPLEMENT APPROVAL
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`DEFERRAL EXTENSION GRANTED
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` Pfizer, Inc.
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` Attention: Nestor Duci, MBA
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` Senior Manager, Global Regulatory Affairs
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` 445 Eastern Point Road
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` Groton, CT 06340
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`Dear Mr. Duci:
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`Please refer to your supplemental new drug application (sNDA) dated and received
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`December 18, 2020, and your amendments, submitted under section 505(b) of the
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`Federal Food, Drug, and Cosmetic Act (FDCA) for Toviaz (fesoterodine fumarate)
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`extended-release tablets.
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`This Prior Approval supplemental new drug application provides for the treatment of
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`neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older
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`and weighing greater than 25 kg.
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`APPROVAL & LABELING
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`We have completed our review of this application, as amended. It is approved, effective
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`on the date of this letter, for use as recommended in the enclosed agreed-upon
`labeling.
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit the
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`the FDA automated drug registration and listing system (eLIST), as described at
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`FDA.gov.1 Content of labeling must be identical to the enclosed labeling text for the
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`Prescribing Information and Patient Package Insert, with the addition of any labeling
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`changes in pending “Changes Being Effected” (CBE) supplements, as well as annual
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`reportable changes not included in the enclosed labeling.
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`Information on submitting SPL files using eList may be found in the guidance for
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`Reference ID: 4813301
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` NDA 022030/S-019
` Page 2
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` The SPL will be accessible from publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications that include labeling
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`changes for this NDA, including CBE supplements for which FDA has not yet issued an
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`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), provide a
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` highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
`Word version. The marked-up copy should provide appropriate annotations, including
`supplement number(s) and annual report date(s).
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` REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
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`new active ingredients (which includes new salts and new fixed combinations), new
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`indications, new dosage forms, new dosing regimens, or new routes of administration
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`are required to contain an assessment of the safety and effectiveness of the product for
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`the claimed indication in pediatric patients unless this requirement is waived, deferred,
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`or inapplicable.
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`We have reviewed your submission dated December 18, 2020, which partially
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`addresses the following postmarketing requirement listed in the October 31, 2008,
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`approval letter for NDA 022030:
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`PMR–1543-3 Deferred pediatric study under PREA for treatment of overactive bladder
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`in the subgroup of pediatric patients with neurologic disease ages 6 to 16
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`years, 11 months.
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`Final Report Submission: January 28, 2021
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`After further considering the facts and circumstances (including the information
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`previously submitted), we are extending the Final Report Submission date. The Final
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`Report Submission date is extended to September 30, 2021.
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`Submit final CMC data
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`For administrative purposes, please clearly mark your submission
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`"SUBMISSION OF REQUIRED PEDIATRIC ASSESSMENTS" in large font, bolded type
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`at the beginning of the cover letter of the submission..
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
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`promotional labeling. For information about submitting promotional materials, see the
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4813301
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`(b) (4)
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` NDA 022030/S-019
` Page 3
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` final guidance for industry Providing Regulatory Submissions in Electronic and Non-
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` Electronic Format-Promotional Labeling and Advertising Materials for Human
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` Prescription Drugs.3
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`You must submit final promotional materials and Prescribing Information, accompanied
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`by a Form FDA 2253, at the time of initial dissemination or publication
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`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
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`Instructions for completing the form can be found at FDA.gov.5
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, please call Nenita Crisostomo, R.N., Regulatory Health
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`Project Manager, at 301-796-0875.
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`Sincerely,
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`{See appended electronic signature page}
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`Christine P. Nguyen, M.D.
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`Director
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`Division of Urology, Obstetrics, and Gynecology
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`Office of Rare Diseases, Pediatrics, Urologic and
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`Reproductive Medicine
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`Center for Drug Evaluation and Research
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`ENCLOSURES:
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`• Content of Labeling
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`o Prescribing Information
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`o Patient Package Insert
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` 3 For the most recent version of a guidance, check the FDA guidance web page at
` https://www.fda.gov/media/128163/download.
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` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4813301
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`Signature Page 1 of 1
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`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
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`/s/
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`CHRISTINE P NGUYEN
`06/17/2021 03:57:02 PM
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`Reference ID: 4813301
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