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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 203214/S-002
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`PF PRISM C.V.
`c/o Pfizer, Inc.
`445 Eastern Point Road
`Groton, CT 06340
`
`Attention: Nickie V. Kilgore, D.V.M.
`
`Director, Worldwide Regulatory Strategy
`
`Dear Dr. Kilgore:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated January 18, 2013,
`received January 18, 2013, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for Xeljanz (tofacitinib) Tablets, 5 mg.
`
`We acknowledge receipt of your amendments dated February 6, May 2, 21, 28, and 30, June 21,
`October 28, and November 12, 2013.
`
`This Prior Approval supplemental new drug application provides the inclusion of language in the
`package insert regarding the improvement in general health status, assessed by the Short Form
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`health survey (SF-36).
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`APPROVAL & LABELING
`
`
`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`text.
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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 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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert, 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.
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`Information on submitting SPL files using eList may be found in the guidance for industry titled
`“SPL Standard for Content of Labeling Technical Qs and As at
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`Reference ID: 3408627
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` NDA 203214/S-002
`Page 2
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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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 includes 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 MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
`annotate each change. To facilitate review of your submission, 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, 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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`REPORTING REQUIREMENTS
`
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call Philantha Bowen, Senior Regulatory Project Management Officer
`at (301) 796-2466.
`
`
`ENCLOSURE:
`Content of Labeling
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`Reference ID: 3408627
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`
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`Sincerely,
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`{See appended electronic signature page}
`
`
`Badrul A. Chowdhury, M.D., Ph.D.
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` Director
`Division of Pulmonary, Allergy, and Rheumatology
`Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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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/
`----------------------------------------------------
`
`BADRUL A CHOWDHURY
`11/18/2013
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`Reference ID: 3408627
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`
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