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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 203214/S-006
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
`REMS MODIFICATION APPROVAL
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`PF PRISM C.V.
`c/o Pfizer, Inc.
`445 Eastern Point Road
`Groton, CT 06340
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`Attention: Nickie V. Kilgore, D.V.M.
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`Director, Worldwide Regulatory Strategy
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`Dear Dr. Kilgore:
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`Please refer to your Supplemental New Drug Application (sNDA) dated September 27, 2013,
`received September 27, 2013, submitted under section 505(b)of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Xeljanz (tofacitinib) and your risk evaluation and mitigation strategy
`(REMS) assessment dated September 27, 2013.
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`This Prior Approval supplemental new drug application provides for proposed modifications to
`the approved REMS and all other relevant REMS materials to reflect the change in NDA
`ownership, including revisions to indicate the new applicant name, address, and contact
`information.
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`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter.
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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
`active ingredients, 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(s) in pediatric patients unless this requirement is waived,
`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) was originally approved on November 6, 2012. The REMS
`consists of a Medication Guide, communication plan, and a timetable for submission of
`assessments of the REMS. Your proposed modifications to the REMS consist of revisions to the
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`Reference ID: 3404212
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`

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` NDA 203214/S-006
`Page 2
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`REMS document and all other relevant REMS materials to reflect the change in NDA
`ownership, including revisions to indicate the new applicant name, address, and contact
`information.
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`The timetable for submission of assessments of the REMS will remain the same as that approved
`on November 6, 2012.
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`There are no changes to the REMS assessment plan described in our November 6, 2012, letter.
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`The requirements for assessments of an approved REMS under section 505-1(g)(3) include with
`respect to each goal included in the strategy, an assessment of the extent to which the approved
`strategy, including each element of the strategy, is meeting the goal or whether 1 or more such
`goals or such elements should be modified.
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`In addition to the assessments submitted according to the timetable included in the approved
`REMS, you must submit a REMS assessment and may propose a modification to the approved
`REMS when you submit a supplemental application for a new indication for use as described in
`section 505-1(g)(2)(A) of the FDCA.
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`If the assessment instruments and methodology for your REMS assessments are not included in
`the REMS supporting document, or if you propose changes to the submitted assessment
`instruments or methodology, you should update the REMS supporting document to include
`specific assessment instrument and methodology information at least 90 days before the
`assessments will be conducted. Updates to the REMS supporting document may be included in a
`new document that references previous REMS supporting document submission(s) for
`unchanged portions. Alternatively, updates may be made by modifying the complete previous
`REMS supporting document, with all changes marked and highlighted. Prominently identify the
`submission containing the assessment instruments and methodology with the following wording
`in bold capital letters at the top of the first page of the submission:
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`NDA 203214 REMS CORRESPONDENCE
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`(insert concise description of content in bold capital letters, e.g.,
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`UPDATE TO REMS SUPPORTING DOCUMENT - ASSESSMENT
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`METHODOLOGY)
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`
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`Prominently identify the submission containing the REMS assessments or proposed
`modifications with the following wording in bold capital letters at the top of the first page of the
`submission:
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`NDA 203214 REMS ASSESSMENT
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`NEW SUPPLEMENT FOR NDA 203214
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`PROPOSED REMS MODIFICATION
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`NEW SUPPLEMENT (NEW INDICATION FOR USE)
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`FOR NDA 203214
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`Reference ID: 3404212
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` NDA 203214/S-006
`Page 3
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`REMS ASSESSMENT
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`PROPOSED REMS MODIFICATION (if included)
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`If you do not submit electronically, please send 5 copies of REMS-related submissions.
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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 Philantha Bowen, Senior Regulatory Project Management
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`Officere, at (301) 796-2466.
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`Sincerely,
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` {See appended electronic signature page}
`
`Sally Seymour, M.D.
`Deputy Director for Safety
`Division of Pulmonary, Allergy, and Rheumatology
`Products
`Office of Drug Evaluation II
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`ENCLOSURE:
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` REMS
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`Reference ID: 3404212
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`

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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
`11/08/2013
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`Reference ID: 3404212
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`