` NDA 203214/S-034
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` NDA 208246/S-021
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`NDA 213082/S-006
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`SUPPLEMENT APPROVAL
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` PF PRISM C.V.
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` c/o Pfizer Inc.
` Attention: LaShanna Lockhart
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` Senior Manager, Regulatory Affairs
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` 66 Hudson Boulevard East
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` New York, NY 10001
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`
` Dear LaShanna Lockhard:
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`Please refer to your supplemental new drug applications (NDAs) dated and received
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` November 15, 2023, and your amendments, submitted under section 505(b) of the
` Federal Food, Drug, and Cosmetic Act (FDCA) for Xeljanz (tofacitinib) tablets, Xeljanz
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` XR (tofacitinib) extended release tablets, and Xeljanz (tofacitinib) Oral Solution.
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` These Prior Approval supplemental NDAs provide for the addition of “acne” to Section
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` 6.2 (Postmarketing Experience) of the Prescribing Information and Medication Guide.
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` APPROVAL & LABELING
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` We have completed our review of these applications, as amended. They are approved,
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` effective on the date of this letter, for use as recommended in the enclosed agreed-
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` upon 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
`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
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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 (Prescribing
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`Information, Instructions for Use, and Medication Guide), with the addition of any
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`Reference ID: 5380731
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`

`

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` NDA 203214/S-034
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` NDA 208246/S-021
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` NDA 213082/S-006
` Page 2
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` labeling changes in pending “Changes Being Effected” (CBE) supplements, as well as
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`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
`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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`Because none of these criteria apply to your application, you are exempt from this
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`requirement.
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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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`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
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`product (21 CFR 4, Subpart B). Additional information on combination product
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`postmarketing safety reporting is available at FDA.gov.3
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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.
` 3 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-
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` reporting-combination-products
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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: 5380731
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`

`

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` NDA 203214/S-034
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` NDA 208246/S-021
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` NDA 213082/S-006
` Page 3
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` If you have any questions, contact Suprat Saely, Regulatory Project Manager, at
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` suprat.saely@fda.hhs.gov or 240-402-1604.
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`
`Sincerely,
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`
`{See appended electronic signature page}
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`
`
`Ozlem Belen, MD, MPH
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`Deputy Director
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`Division of Rheumatology and Transplant Medicine
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`Office of Immunology and Inflammation
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`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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` Prescribing Information
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` Medication Guide
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`Instructions for Use
`
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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: 5380731
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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/
`------------------------------------------------------------
`
`OZLEM A BELEN
`05/14/2024 11:50:13 AM
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`Reference ID: 5380731
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`
`
`