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`
`
` NDA 022030/S-019
`
`
`
` SUPPLEMENT APPROVAL
`
`DEFERRAL EXTENSION GRANTED
`
`
`
`
`
` Pfizer, Inc.
`
` Attention: Nestor Duci, MBA
`
` Senior Manager, Global Regulatory Affairs
`
` 445 Eastern Point Road
`
` Groton, CT 06340
`
`
`
`
`Dear Mr. Duci:
`
`
`
`Please refer to your supplemental new drug application (sNDA) dated and received
`
`December 18, 2020, and your amendments, submitted under section 505(b) of the
`
`
`
`
`Federal Food, Drug, and Cosmetic Act (FDCA) for Toviaz (fesoterodine fumarate)
`
`extended-release tablets.
`
`
`
`
`This Prior Approval supplemental new drug application provides for the treatment of
`
`
`
`neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older
`
`and weighing greater than 25 kg.
`
`
`APPROVAL & LABELING
`
`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 enclosed agreed-upon
`labeling.
`
`
`CONTENT OF LABELING
`
`
`
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the
`
`
`
`
`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
`
`
`
`
`the FDA automated drug registration and listing system (eLIST), as described at
`
`
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling text for the
`
`
`
`Prescribing Information and Patient Package Insert, with the addition of any labeling
`
`
`changes in pending “Changes Being Effected” (CBE) supplements, as well as annual
`
`reportable changes not included in the enclosed labeling.
`
`
`Information on submitting SPL files using eList may be found in the guidance for
`
`
`industry SPL Standard for Content of Labeling Technical Qs and As.2
`
`
`
`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`
`
` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`
`
`
`
`Reference ID: 4813301
`
`

`

`
`
`
`
`
`
`
` NDA 022030/S-019
` Page 2
`
`
`
` The SPL will be accessible from publicly available labeling repositories.
`
`
`
`
`Also within 14 days, amend all pending supplemental applications that include labeling
`
`changes for this NDA, including CBE supplements for which FDA has not yet issued an
`
`
`
`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
`
`
`
`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
`
`
`
`
`
` 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).
`
`
`
`
` REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
`
`
`
`new active ingredients (which includes new salts and new fixed combinations), 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 have reviewed your submission dated December 18, 2020, which partially
`
`
`
`addresses the following postmarketing requirement listed in the October 31, 2008,
`
`
`
`approval letter for NDA 022030:
`
`
`PMR–1543-3 Deferred pediatric study under PREA for treatment of overactive bladder
`
`
`
`
`in the subgroup of pediatric patients with neurologic disease ages 6 to 16
`
`
`
`years, 11 months.
`
`
`
`
`
`Final Report Submission: January 28, 2021
`
`
`
`
`
`After further considering the facts and circumstances (including the information
`
`
`
`previously submitted), we are extending the Final Report Submission date. The Final
`
`
`
`
`
`Report Submission date is extended to September 30, 2021.
`
`
`
`Submit final CMC data
`
`For administrative purposes, please clearly mark your submission
`
`
`
`"SUBMISSION OF REQUIRED PEDIATRIC ASSESSMENTS" in large font, bolded type
`
`
`
`at the beginning of the cover letter of the submission..
`
`
`
`
`PROMOTIONAL MATERIALS
`
`
`You may request advisory comments on proposed introductory advertising and
`
`
`promotional labeling. For information about submitting promotional materials, see the
`
`
`
`
`
`
`
`
`
`U.S. Food and Drug Administration
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`Reference ID: 4813301
`
`(b) (4)
`
`

`

`
`
`
` NDA 022030/S-019
` Page 3
`
`
`
` final guidance for industry Providing Regulatory Submissions in Electronic and Non-
`
`
`
`
` Electronic Format-Promotional Labeling and Advertising Materials for Human
`
` Prescription Drugs.3
`
`
`
`
`You must submit final promotional materials and Prescribing Information, accompanied
`
`
`
`by a Form FDA 2253, at the time of initial dissemination or publication
`
`
`
`
`
`
`
`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
`
`
`
`Instructions for completing the form can be found at FDA.gov.5
`
`
`REPORTING REQUIREMENTS
`
`
`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, please call Nenita Crisostomo, R.N., Regulatory Health
`
`
`Project Manager, at 301-796-0875.
`
`
`
`
`Sincerely,
`
`
`
`{See appended electronic signature page}
`
`
`
`Christine P. Nguyen, M.D.
`
`Director
`
`Division of Urology, Obstetrics, and Gynecology
`
`
`Office of Rare Diseases, Pediatrics, Urologic and
`
`Reproductive Medicine
`
`Center for Drug Evaluation and Research
`
`
`
`ENCLOSURES:
`
`
`• Content of Labeling
`
`
`o Prescribing Information
`
`
`o Patient Package Insert
`
`
`
`
`
` 3 For the most recent version of a guidance, check the FDA guidance web page at
` https://www.fda.gov/media/128163/download.
`
`
`
` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`
`
` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`U.S. Food and Drug Administration
`
`
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`
`
`Reference ID: 4813301
`
`

`

`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`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.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`CHRISTINE P NGUYEN
`06/17/2021 03:57:02 PM
`
`Reference ID: 4813301
`
`

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