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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 022253/S-023
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`NDA 022254/S-015
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`NDA 022255/S-009
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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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`UCB, Inc.
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`Attention: Susan Tegtmeyer, M.S.
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`Associate Director, Regulatory Affairs
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`1950 Lake Park Drive,
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`Smyrna, Georgia 30080
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`Dear Ms. Tegtmeyer:
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`Please refer to your Supplemental New Drug Application (sNDA) dated April 6, 2012, received
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`April 6, 2012, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
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`(FDCA) for Vimpat (lacosamide) tablets, Vimpat (lacosamide) Injection, and Vimpat
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`(lacosamide) oral solution.
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`We acknowledge receipt of your amendments dated May 3, 2013; October 11, 2013; October 22,
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`2013; November 19, 2013; and December 9, 2013.
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`This “Changes Being Effected” supplemental new drug application provides for new unit dose
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`packaging for use in hospitals and long-term care settings. The unit dose packaging configuration
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`contains a carton with 6 blister cards and 10 unit dose tablets per card for a total of 60 unit dose
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`tablets per carton. This unit dose packaging configuration will be available for the 50 mg, 100
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`mg, 150 mg, and 200 mg strength tablets. Included in this submission is the revised package
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`insert containing the new unit dose configuration for each strength in the “How Supplied”
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`section.
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`Also included in the package insert are revisions to the language in the “Highlights” and the
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`“Dosage and Administration” section that were made for reasons dosage clarification and to
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`comply with the FDA style. These revisions were recommended by the FDA and agreed upon
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`by the Sponsor.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application. It is approved, effective on the
`date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
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`Reference ID: 3437671
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`

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` NDA 022253/S-023
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` NDA 022254/S-015
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` NDA 022255/S-009
`Page 2
` CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
`automated drug registration and listing system (eLIST), as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert and Medication
`Guide), with the addition of any labeling changes in pending “Changes Being Effected” (CBE)
`supplements, as well as annual reportable changes not included in the enclosed labeling.
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`Information on submitting SPL files using eList may be found in the guidance for industry titled
`“SPL Standard for Content of Labeling Technical Qs and As at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
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`The SPL will be accessible from publicly available labeling repositories.
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`Also within 14 days, amend all pending supplemental applications that includes labeling changes
`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
`annotate each change. To facilitate review of your submission, provide a highlighted or marked-
`up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
`should provide appropriate annotations, including supplement number(s) and annual report
`date(s).
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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 carton and
`immediate-container labels submitted on November 19, 2013 and December 9, 2013, 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 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 022253/S-023; NDA 022254/S-015; NDA 022255/S-009.”
`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 product misbranded and an unapproved new drug.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
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`Reference ID: 3437671
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`

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` NDA 022253/S-023
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` NDA 022254/S-015
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` NDA 022255/S-009
`Page 3
`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) to:
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion (OPDP)
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
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`FDA 2253 is available at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`more information about submission of promotional materials to the Office of Prescription Drug
`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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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 Stephanie N. Parncutt, MHA, Regulatory Project Manager, at
`(301) 796-4098.
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`Sincerely,
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`{See appended electronic signature page}
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`
`Eric Bastings, M.D.
`Deputy Director
`Division of Neurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
`Content of Labeling
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`Reference ID: 3437671
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`

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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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`ERIC P BASTINGS
`01/16/2014
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`Reference ID: 3437671
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`