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` DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` Food and Drug Administration
` Silver Spring MD 20993
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` SUPPLEMENT APPROVAL
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` RELEASE FROM REMS REQUIREMENT
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` NDA 203214/S-013
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` P F Prism C.V.
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` c/o Pfizer Inc.
` 500 Arcola Road
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` Collegeville, PA 19426
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` Attention:
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` Alicia Holsey, M.S., RAC
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` Senior Manager, Worldwide Safety and Regulatory
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` Dear Ms. Holsey:
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` Please refer to your Supplemental New Drug Application (sNDA) dated and received January
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` 20, 2016, submitted under section 505(b) for Xeljanz (tofacitinib) Tablets, 5 mg.
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` We also refer to our REMS Modification Notification letter dated January 13, 2016, and we
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` acknowledge receipt of your risk evaluation and mitigation strategy (REMS) assessment dated
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` November 6, 2015.
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` This prior approval supplemental application provides for proposed modification to the approved
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` REMS and proposes to eliminate the requirement for the approved REMS for Xeljanz
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`(tofacitinib).
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` We have completed our review of this supplemental application. It is approved, effective on the
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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 new
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`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
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`administration are required to contain an assessment of the safety and effectiveness of the
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`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
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`deferred, or inapplicable.
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`Because none of these criteria apply to your application, you are exempt from this requirement.
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`RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
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`The REMS for Xeljanz (tofacitinib) Tablets was originally approved on November 6, 2012,
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`Reference ID: 3884453
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`

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` NDA 203214/S-013
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` Page 2
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` and the most recent REMS modification was approved on June 19, 2015. The REMS consists of
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` a communication plan and a timetable for submission of assessments of the REMS.
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` Your proposed modifications consist of elimination of the communication plan, and therefore,
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` release from the requirement for a REMS for Xeljanz (tofacinib).
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` As communicated in the January 13, 2016 REMS Modification Notification Letter, we
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` determined a communication plan is no longer necessary to include as an element of the
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` approved REMS because the communication plan has been completed and the most recent
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` assessment demonstrates that the communication plan has met its goals.
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` Therefore, because the communication plan is no longer necessary to ensure the benefits of the
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` drug outweigh the risks, a REMS is no longer required for Xeljanz (tofacitinib).
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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 Carol F. Hill, Senior Regulatory Health Project Manager for
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`Safety, at (301) 796-1226.
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`Sincerely,
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`{See appended electronic signature page}
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`Sally Seymour, MD
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`Deputy Director for Safety
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`Division of Pulmonary, Allergy, and Rheumatology
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`Office of Drug Evaluation II
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`Center for Drug Evaluation and Research
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`Reference ID: 3884453
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`SALLY M SEYMOUR
`02/08/2016
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`Reference ID: 3884453
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