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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 202155/S-004
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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: Linda Gambone, Ph.D.
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`Associate Director, Global Regulatory Sciences
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`P.O. Box 4000
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`Princeton, NJ 08543-4000
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`Dear Dr. Gambone:
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`Please refer to your Supplemental New Drug Application (sNDA) dated July 17, 2013, received July 17,
`2013, 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 provides new carton and container labels for a 2.5
`mg physician sample and amended carton and container labels for the 5.0 mg physician sample.
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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. As a reminder,
`please ensure that the lot number and expiration date are included on both the 2.5 mg and 5 mg
`professional sample carton labeling.
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and immediate container labels that are identical to the enclosed carton and
`immediate container labels, as soon as they are available, but no more than 30 days after they are printed.
`Please submit these labels electronically according to the guidance for industry Providing Regulatory
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`Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related
`Submissions Using the eCTD Specifications (June 2008). Alternatively, you may submit 12 paper copies,
`with 6 of the copies individually mounted on heavy-weight paper or similar material. For administrative
`purposes, designate this submission “Final Printed Carton and Container Labels for approved
`NDA 202155/S-004.” Approval of this submission by FDA is not required before the labeling is used.
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`Marketing the product(s) with FPL that is not identical to the approved labeling text may render the
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`product misbranded and an unapproved new drug.
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`Reference ID: 3399687
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` NDA 202155/S-004 Approval Letter
`Page 2
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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, please call:
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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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`Norman Stockbridge, M.D., Ph.D.
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`Director
`Division of Cardiovascular & 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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`Carton and Container Labeling
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`Reference ID: 3399687
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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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`NORMAN L STOCKBRIDGE
`10/31/2013
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`Reference ID: 3399687
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