` NDA 203214/S-028
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` NDA 208246/S-013
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` NDA 213082/S-003
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`SUPPLEMENT APPROVAL
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` PF PRISM C.V.
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` 500 Arcola Road
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` Collegeville, PA 19426
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`Attention:
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`Dear Dr. Evans:
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`Please refer to your supplemental new drug application (sNDA) dated June 19, 2020,
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`received June 19, 2020, and your amendments, submitted under section 505(b) of the
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`Federal Food, Drug, and Cosmetic Act (FDCA) for Xeljanz (tofacitinib) Tablet and
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`Xeljanz (tofacitinib) Extended Release Tablet.
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`Also, refer to your supplemental new drug application (sNDA) dated September 1, 2021,
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`received September 1, 2021, and your amendments, submitted under section 505(b) of
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`the Federal Food, Drug, and Cosmetic Act (FDCA) for Xeljanz (tofacitinib) Oral Solution.
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`We acknowledge receipt of your major amendment dated March 8, 2021, which
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`extended the goal date by three months.
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`Prior Approval supplemental new drug applications NDA 203214 S-028 and NDA
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`208246 S-013 provide for the addition of the indication of the treatment of adult patients
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`with active ankylosing spondylitis who have had an inadequate response or intolerance
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`to one or more TNF blockers, to the prescribing information.
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`Prior Approval supplemental new drug application NDA 213082 S-003 provides for
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`alignment of the labeling for the oral solution formulation.
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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
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`labeling.
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`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
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`Please note that we have previously granted a waiver of the requirements of 21 CFR
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`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
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`
`
`Mark Evans, PhD
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`Global Regulatory Team Lead, Pfizer Global Regulatory Affairs
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`Reference ID: 4904169
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`

`

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` NDA 203214/S-028
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` NDA 208246/S-013
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` NDA 213082/S-003
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` Page 2
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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, Instructions for Use, and Medication Guide), with the addition of
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`any labeling changes in pending “Changes Being Effected” (CBE) supplements, as well
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`as annual 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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`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
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`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
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`Word version. The marked-up copy should provide appropriate annotations, including
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`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 are waiving the pediatric study requirement for this application because necessary
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`studies are impossible or highly impracticable.
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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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`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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`
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`Reference ID: 4904169
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`

`

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` NDA 203214/S-028
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` NDA 208246/S-013
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` NDA 213082/S-003
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` Page 3
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
`promotional labeling. For information about submitting promotional materials, see the
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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
` [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, call Elaine SIt, Regulatory Project Manager, at (301) 796-
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` 5073.
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` Sincerely,
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` {See appended electronic signature page}
`
` Nikolay P. Nikolov, MD
`
` Director
` Division of Rheumatology and Transplant Medicine
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`
`
` Office of Immunology and Inflammation
` Office of New Drugs
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` Center for Drug Evaluation and Research
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`ENCLOSURE(S):
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`• Content of Labeling
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`o Prescribing Information
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`o Medication Guide
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`Instructions for Use
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`o
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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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`
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4904169
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`

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`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/
`------------------------------------------------------------
`
`NIKOLAY P NIKOLOV
`12/14/2021 11:51:29 AM
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`Reference ID: 4904169
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`(
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