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` DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 202155/S-014
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` Food and Drug Administration
` Silver Spring MD 20993
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` SUPPLEMENT APPROVAL
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` RELEASE REMS REQUIREMENT
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` Bristol-Myers Squibb Company
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` Attention: Diptee Gajjar, B. Pharm., Ph.D.
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` Director, Global Regulatory Lead, Global Regulatory & Safety Sciences
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` P.O. Box 4000
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` Princeton, NJ 08543-4000
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` Dear Dr. Gajjar:
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` Please refer to your Supplemental New Drug Application (sNDA) dated and received February
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` 9, 2016, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA)
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` for Eliquis (apixaban) 2.5 mg and 5 mg Tablets.
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` We also refer to our REMS Modification Notification letter dated January 26, 2016, and we
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` acknowledge receipt of your risk evaluation and mitigation strategy (REMS) assessment dated
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` June 26, 2014.
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` This prior approval supplemental new drug application provides for proposed modification to the
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` approved REMS to eliminate the requirement for the approved REMS for Eliquis (apixaban).
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` APPROVAL & LABELING
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`We have completed our review of this supplemental application, and it is approved, effective on
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`the date of this letter.
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`RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
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`The REMS for Eliquis (apixaban) was originally approved on December 28, 2012, and the most
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`recent modification was approved on August 12, 2014. The REMS consists of a communication
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`plan, and a timetable for submission of assessments of the REMS.
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`In order to minimize burden on the healthcare delivery system of complying with the REMS, we
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`determined that you were required to make the following REMS modifications:
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` Removal of the Communication Plan as an element of the REMS
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` Elimination of the required Eliquis (apixaban) REMS
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`Reference ID: 3895871
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` NDA 202155/S-014
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` Page 2
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` As communicated in the January 26, 2016, REMS Modification Notification Letter, we
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` determined a communication plan is no longer necessary to include as an element of the
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` approved REMS because the communication plan has been completed and the most recent
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` assessment demonstrates that the communication plan has met its goals.
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` Therefore, because the communication plan is no longer necessary to ensure the benefits of the
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` drug outweigh the risks, a REMS is no longer required for Eliquis (apixaban).
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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, please call:
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`Lori Anne Wachter, RN, BSN, RAC
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`Regulatory Project Manager for Safety
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`(301) 796-3975
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`Sincerely,
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`{See appended electronic signature page}
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`Mary Ross Southworth, PharmD.
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`Deputy Director for Safety
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`Division of Cardiovascular and Renal Products
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`Office of Drug Evaluation I
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`Center for Drug Evaluation and Research
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`Reference ID: 3895871
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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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`MARY R SOUTHWORTH
`03/02/2016
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`Reference ID: 3895871
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