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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 203214/S-007
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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.
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` 445 Eastern Point Road
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` Groton, CT 06340
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`Attention: Perc Reeve, D.V.M.
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`Worldwide Regulatory Strategy
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`Dear Dr. Reeve:
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`Please refer to your Supplemental New Drug Application (sNDA) dated April 15, 2014, received
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`April 15, 2014, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
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`(FDCA) for Xeljanz (tofacitinib), 5 mg.
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`This Changes Being Effected supplemental new drug application provides for editorial revisions
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`to the CLINICAL STUDIES: Confirmatory Trials Section of the package insert.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application. It is approved, effective on the
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`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
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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`automated drug registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`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)
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`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
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`“SPL Standard for Content of Labeling Technical Qs and As at
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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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`Reference ID: 3502430
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` NDA 203214/S-007
` Page 2
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` Also within 14 days, amend all pending supplemental applications that includes labeling changes
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`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
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`changes approved in this supplemental application, as well as annual reportable changes and
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`annotate each change. To facilitate review of your submission, provide a highlighted or marked-
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`up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
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`should provide appropriate annotations, including supplement number(s) and annual report
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`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 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
`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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`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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`Officer, at (301) 796-2466.
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`Sincerely,
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`{See appended electronic signature page}
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`Sally Seymour, M.D.
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`Deputy Director for Safety
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`Division of Pulmonary, Allergy, and Rheumatology
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`Products
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`Office of Drug Evaluation II
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`ENCLOSURE:
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`Content of Labeling
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`Reference ID: 3502430
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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
`05/07/2014
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`Reference ID: 3502430
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