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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
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`Silver Spring MD 20993
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`NDA 22253/S-020
`NDA 22254/S-013
`NDA 22255/S-007
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`SUPPLEMENT APPROVAL
`RELEASE REMS REQUIREMENT
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`
`UCB, Inc.
`Attention: Susan Tegtmeyer, M.S.
`Associate Director, Regulatory Affairs
`1950 Lake Park Drive
`Smyrna, Georgia 30080
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`Dear Ms. Tegtmeyer:
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`Please refer to your Supplemental New Drug Application (sNDA) dated July 13, 2011, received
`July 13, 2011, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for Vimpat (lacosamide) Tablets, Oral Solution, and Injection.
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`We acknowledge receipt of your risk evaluation and mitigation strategy (REMS) assessment
`dated July 26, 2011.
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`This supplemental new drug application proposes to eliminate the requirement for the approved
`Vimpat (lacosamide) REMS.
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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.
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`RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
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`The REMS for Vimpat (lacosamide) was originally approved on October 28, 2008, and the most
`recent REMS modification was approved on April 20, 2010. The REMS consists of a
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`Medication Guide and a timetable for submission of assessments of the REMS.
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`You propose that FDA no longer require a REMS for Vimpat (lacosamide).
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`We have determined that maintaining the Medication Guide as part of the approved labeling is
`adequate to address the serious and significant public health concern and meets the standard in
`21 CFR 208.1. Therefore, it is no longer necessary to include the Medication Guide as an
`element of the approved REMS to ensure that the benefits of Vimpat (lacosamide) outweigh its
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`risks.
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`Reference ID: 2997989
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`Sincerely,
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` {See appended electronic signature page}
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`Russell G. Katz, MD
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` Director
`Division of Neurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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` NDA 22253/S-020
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` NDA 22254/S-013
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` NDA 22255/S-007
`Page 2
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`Therefore, we agree with your proposal and a REMS for Vimpat (lacosamide) is no longer
`required.
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`We remind you that the Medication Guide will continue to be part of the approved labeling in
`accordance with 21 CFR 208.
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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, call Jacqueline Ware, PharmD, Senior Regulatory Project Manager, at
`(301) 796-1160.
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`Reference ID: 2997989
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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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`RUSSELL G KATZ
`08/10/2011
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`Reference ID: 2997989
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