`RESEARCH
`
`
`
`
`
`APPLICATION NUMBER:
`022255Orig1s000
`
`REMS
`
`
`
`
`
`
`
`
`
`
`
`Vimpat (lacosamide)
`
`NDA 022253/S-006, NDA 022254/S-003, NDA 022255
`
`
`VIMPAT® (lacosamide) Risk Evaluation and Mitigation Strategy (REMS)
`NDA 022255 VIMPAT® (lacosamide) oral solution CV
`
`NDA 022253 VIMPAT® (lacosamide) tablets CV
`
`
`NDA 022254 VIMPAT® (lacosamide) injection CV
`
`Antiepileptic Drug
`
`Schwarz Biosciences, Inc., a member of the UCB Group of Companies
`
`1950 Lake Park Drive, Smyrna, GA 30080
`
`
`
` UCB, Inc.
`
`
`
` 1 GOAL
`
`The goal of this REMS is to communicate the risks of VIMPAT.
`
`2 REMS ELEMENTS
` 2.1. Medication Guide
`
`A Medication Guide will be dispensed with each VIMPAT prescription. UCB will assure
`that Medication Guides are provided with each order in sufficient quantity to assure that a
`Medication Guide is available at the time of dispensing to the patient. As printed materials,
`Medication Guides will be controlled using appropriate techniques (i.e. barcoding) to assure
`that the correct Medication Guide is provided with each product order that UCB fills.
`
` The container labeling for the product will contain prominent and conspicuous instruction to
`authorized dispensers to provide a Medication Guide to each patient to whom the product is
`dispensed. In addition, the Medication Guide will be publicly available on the VIMPAT
`product website, www.vimpat.com.
`
`
`
`2.2. Communication Plan
` The VIMPAT REMS does not include a Communication Plan.
`
`
`
` 2.3. Elements to Assure Safe Use
`
`The VIMPAT REMS does not include Elements to Assure Safe Use.
`
`
`Implementation System
`2.4.
`The VIMPAT REMS does not include Elements to Assure Safe Use, therefore no
`Implementation System is required.
`
`
`2.5. Timetable for Submission of REMS Assessments
`The Sponsor will submit REMS assessments to the FDA 18 months, 3 years, and 7 years
`from the date of original approval of the REMS (28 April 2010, 28 October 2011 and 28
`October 2015, respectively). To facilitate inclusion of as much information as possible while
`allowing reasonable time to prepare the submission, the reporting interval covered by each
`assessment should conclude no earlier than 60 days before the submission date for that
`assessment. UCB will submit each assessment so that it will be received by the FDA on or
`before the due date.
`
`Confidential
`
`
`Page 1 of 1
`
`
`
`Application
`Type/Number
`--------------------
`NDA-22255
`
`Submission
`Type/Number
`--------------------
`ORIG-1
`
`NDA-22253
`
`SUPPL-6
`
`NDA-22254
`
`SUPPL-3
`
`Submitter Name
`
`Product Name
`
`--------------------
`SCHWARZ
`BIOSCIENCES INC
`SCHWARZ
`BIOSCIENCES INC
`SCHWARZ
`BIOSCIENCES INC
`
`------------------------------------------
`VIMPAT
`
`VIMPAT
`
`VIMPAT
`
`---------------------------------------------------------------------------------------------------------
`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
`04/20/2010
`
`
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