NDA 203214/S-036
`NDA 208246/S-023
`
`NDA 213082/S-008
`
`
`
`SUPPLEMENT APPROVAL
`
`
`PF PRISM C.V
`c/o Pfizer Inc.
`66 Hudson Boulevard East
`New York, NY 10001
`
`
`Attention: LaShanna Lockhart, MSJ, MBA-HA, CCRP
`
`
` Senior Manager, Regulatory Affairs
`
`Dear LaShanna Lockhart:
`
`Please refer to your supplemental new drug applications (NDAs) dated and received
`March 29, 2024, and your amendments, submitted under section 505(b) of the Federal
`Food, Drug, and Cosmetic Act (FDCA) for Xeljanz (tofacitinib) tablets, Xeljanz XR
`(tofacitinib) extended release tablets, and Xeljanz (tofacitinib) oral solution, respectively.
`
`
`These Prior Approval supplemental NDAs update the U.S. Prescribing Information
`(USPI) and the Medication Guide about the Tofacitinib Pregnancy Exposure Registry
`that was designed to monitor planned or unplanned pregnancies exposed to tofacitinib
`when used to treat rheumatoid arthritis (RA).
`
`APPROVAL & LABELING
`
`We have completed our review of these applications, as amended. They are 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, Instructions for Use, and Medication Guide), 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.
`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`
`
`
`
`Reference ID: 5453985
`
`

`

`
` NDA 203214/S-036
`
` NDA 208246/S-023
`
` NDA 213082/S-008
`
` Page 2
`
`
`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
`
`
`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.
`
`Because none of these criteria apply to your supplemental application, you are exempt
`from this requirement.
`
`PATENT LISTING REQUIREMENTS
`
`
`Pursuant to 21 CFR 314.53(d)(2) and 314.70(f), certain changes to an approved NDA
`submitted in a supplement require you to submit patent information for listing in the
`Orange Book upon approval of the supplement. You must submit the patent information
`required by 21 CFR 314.53(d)(2)(i)(A) through (C) and 314.53(d)(2)(ii)(A) and (C), as
`applicable, to FDA on Form FDA 3542 within 30 days after the date of approval of the
`supplement for the patent information to be timely filed (see 21 CFR
`314.53(c)(2)(ii)). You also must ensure that any changes to your approved NDA that
`require the submission of a request to remove patent information from the Orange Book
`are submitted to FDA at the time of approval of the supplement pursuant to 21 CFR
`314.53(d)(2)(ii)(B) and 314.53(f)(2)(iv).
`
`
`
`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.
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 5453985
`
`

`

`NDA 203214/S-036
`NDA 208246/S-023
`NDA 213082/S-008
`Page 3
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`Your product is a Part 3 combination product (21 CFR 3.2(e)); therefore, you must also
`comply with postmarketing safety reporting requirements for an approved combination
`product (21 CFR 4, Subpart B). Additional information on combination product
`postmarketing safety reporting is available at FDA.gov.*
`
`If you have any questions, contact Javonna Stevens, Regulatory Project Manager, at
`(301) 796-4240 or Javonna.stevens@fda.hhs.gov.
`
`Sincerely,
`
`{See appendedelectronic signature page}
`
`Hyon Kwon, PharmD, MPH
`Deputy Director for Safety
`Division of Rheumatology and Transplant Medicine
`Office of Immunology and Inflammation
`Office of New Drugs
`Center for Drug Evaluation and Research
`
`ENCLOSURE(S):
`Content of Labeling
`= Prescribing Information
`=» Medication Guide
`=
`Instructions for Use — oral solution (approved May 2024)
`
`
`reporting-combination-products
`
`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 5453985
`
`

`

`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/
`------------------------------------------------------------
`
`HYON J KWON
`09/27/2024 03:21:38 PM
`
`Reference ID: 5453985
`
`(
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`
`