NDA 203214/S-023
`NDA 208246/S-011
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`SUPPLEMENT APPROVAL
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`Pfizer, Inc.
`Attention: Louis M. Ferrara
`Director, Worldwide Safety and Regulatory
`445 Eastern Point Road
`Groton, CT 06340
`
`Dear Mr. Ferrara:
`
`Please refer to your supplemental New Drug Applications (sNDA) dated January 29,
`2019, received January 29, 2019, and your amendments, submitted under section
`505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA), for XELJANZ (tofacitinib)
`tablets (5 mg and 10 mg) and XELJANZ XR (tofacitinib) extended-release tablet (11
`mg).
`
`These Prior Approval supplemental new drug applications provide for a correction to the
`descriptive statistics for Study A3921139 (Study UC-IV) study in Section 14.3 of the
`Prescribing Information (PI).
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`APPROVAL & LABELING
`
`We have completed our review of this application, as amended. It is approved, effective
`on the date of this letter, for use as recommended in the enclosed agreed-upon labeling
`with the following editorial change to the PI: updated revision date to the approval date.
`
`CONTENT OF LABELING
`
`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
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`Prescribing Information and 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 SPL Standard for Content of Labeling Technical Qs and As.2
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`1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`Reference ID: 4484853
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`Page 2
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`NDA 203214/S-023
`NDA 208246/S-011
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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
`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 Microsoft Word
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), 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).
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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).
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`If you have any questions, contact Kelly Richards, Senior Regulatory Health Project
`Manager, at (240) 402-4276 or kelly.richards@fda.hhs.gov
`
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`Sincerely,
`
`{See appended electronic signature page}
`
`Joyce Korvick, MD, MPH
`Deputy Director for Safety
`Division of Gastroenterology and Inborn Errors
`Products
`Office of Drug Evaluation III
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
` Content of Labeling
`o Prescribing Information
`o Medication Guide
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`U.S. Food and Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4484853
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`Signature Page 1 of 1
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`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.
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`/s/
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`JOYCE A KORVICK
`08/30/2019 10:31:59 AM
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`Reference ID: 4484853
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