`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`
`Food and Drug Administration
`
`Silver Spring MD 20993
`
`
`
`
`
`
`NDA 22253/S-020
`NDA 22254/S-013
`NDA 22255/S-007
`
`SUPPLEMENT APPROVAL
`RELEASE REMS REQUIREMENT
`
`
`UCB, Inc.
`Attention: Susan Tegtmeyer, M.S.
`Associate Director, Regulatory Affairs
`1950 Lake Park Drive
`Smyrna, Georgia 30080
`
`
`Dear Ms. Tegtmeyer:
`
`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.
`
`We acknowledge receipt of your risk evaluation and mitigation strategy (REMS) assessment
`dated July 26, 2011.
`
`This supplemental new drug application proposes to eliminate the requirement for the approved
`Vimpat (lacosamide) REMS.
`
`We have completed our review of this supplemental application. It is approved, effective on the
`
`date of this letter.
`
`RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
`
`
`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
`
`Medication Guide and a timetable for submission of assessments of the REMS.
`
`You propose that FDA no longer require a REMS for Vimpat (lacosamide).
`
`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
`
`risks.
`
`
`Reference ID: 2997989
`
`
`
`
`
`Sincerely,
`
` {See appended electronic signature page}
`
`Russell G. Katz, MD
`
` Director
`Division of Neurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`
` NDA 22253/S-020
`
` NDA 22254/S-013
`
` NDA 22255/S-007
`Page 2
`
`
`Therefore, we agree with your proposal and a REMS for Vimpat (lacosamide) is no longer
`required.
`
`We remind you that the Medication Guide will continue to be part of the approved labeling in
`accordance with 21 CFR 208.
`
`REPORTING REQUIREMENTS
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call Jacqueline Ware, PharmD, Senior Regulatory Project Manager, at
`(301) 796-1160.
`
`
`
`
`
`
`Reference ID: 2997989
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`RUSSELL G KATZ
`08/10/2011
`
`Reference ID: 2997989
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
