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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 202155/S-010
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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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`Bristol-Myers Squibb
`ATTENTION: Sekayi Mushonga, PharmD
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`Director, US Regulatory Liaison CV & Metabolics
`P.O. Box 4000
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`Princeton, NJ 08543-4000
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`Dear Dr. Mushonga:
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`Please refer to your Supplemental New Drug Application (sNDA) dated 4 November 2014, received
`4 November 2014, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA)
`for Eliquis (apixaban) 2.5 and 5 mg Tablets.
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`This Prior Approval supplemental new drug application proposes edits to consolidate and clarify dose
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`adjustment information in labeling in Section 2 Dosing and Administration and 8 Use in Specific
`Populations. Editorial changes were also made to the labeling language in Section 8 and Section 12
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`Clinical Pharmacology.
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`APPROVAL & LABELING
`We have completed our review of this supplemental application, as amended. It is approved, effective on
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`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
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`[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), with the addition of any
`labeling changes in pending “Changes Being Effected” (CBE) supplements, as well as annual reportable
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`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
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM0723
`92.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
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`Reference ID: 3780211
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`NDA 202155/S-010 – Approval Letter
`Page 2
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`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
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`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
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`and 314.81).
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`Please submit a supplement in response to this letter within 60 days. If you have any questions, please
`contact:
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`Alison Blaus, RAC
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`Senior Regulatory Project Manager
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`(301) 796-1138
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`Sincerely,
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`{See appended electronic signature page}
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`Mary Ross Southworth, Pharm.D.
`Deputy Director for Safety
`Division of Cardiovascular and Renal Products
`Office of Drug Evaluation I
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`Center for Drug Evaluation and Research
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`ENCLOSURE:
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`Content of Labeling
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`Reference ID: 3780211
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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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`ALISON L BLAUS
`06/16/2015
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`MARY R SOUTHWORTH
`06/16/2015
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`Reference ID: 3780211
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