( .I# I U.S. FOOD & DRUG
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`,.,. .........
`•-..:::::i~
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`ADMINISTRATION
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` NDA 022253/S-051
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` NDA 022254/S-041
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` NDA 022255/S-033
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`SUPPLEMENT APPROVAL
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`UCB, Inc.
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`Attention: Kelly Roney, Ph.D., RAC
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`US Regulatory Science Team Lead, Epilepsies America
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`4000 Paramount Parkway, Suite 200
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`Morrisville, NC 27560
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`Dear Dr. Roney:
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`We have received your supplemental new drug applications (sNDAs) submitted under
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`section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA or the Act) for the
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`following:
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`
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`Application
`NDA 022253/S-
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` 051
`NDA 022254/S-
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` 041
`NDA 022255/S-
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` 033
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` March 25, 2021 March 25, 2021
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`Product Name
` Vimpat (lacosamide)
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` Tablets
` Vimpat (lacosamide)
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` Injection
` Vimpat (lacosamide)
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` Oral Solution
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`
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` These Prior Approval supplements provide for:
` The addition of dyskinesia to Subsection 6.2 (Adverse Reactions; Postmarketing
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`
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` Experience) of the Prescribing Information.
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`Received on:
`Submitted on:
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` March 25, 2021 March 25, 2021
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` March 25, 2021 March 25, 2021
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`APPROVAL & LABELING
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`We have completed our review of these applications. They are approved, effective on
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`the date of this letter, for use as recommended in the enclosed agreed-upon labeling.
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`Reference ID: 4857491
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`

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` NDA 022253/S-051
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` NDA 022254/S-041
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` NDA 022255/S-033
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` Page 2
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` 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
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` content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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` the FDA automated drug registration and listing system (eLIST), as described at
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` FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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`Prescribing Information and Medication Guide), with the addition of any labeling
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`changes in pending “Changes Being Effected” (CBE) supplements, as well as annual
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`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
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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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 include labeling
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`changes for these NDAs, including CBE supplements for which FDA has not yet issued
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`an action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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`format, that includes the changes approved in these supplemental applications, as well
`as annual reportable changes. To facilitate review of your submission(s), provide a
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`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
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`supplement number(s) and annual report date(s).
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
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`promotional labeling. For information about submitting promotional materials, see the
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`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
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`Electronic Format-Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.3
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`You must submit final promotional materials and Prescribing Information, accompanied
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`by a Form FDA 2253, at the time of initial dissemination or publication
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`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
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`Instructions for completing the form can be found at FDA.gov.5
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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` 3 For the most recent version of a guidance, check the FDA guidance web page at
` https://www.fda.gov/media/128163/download.
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`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
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`
`U.S. Food and Drug Administration
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`
`
`Silver Spring, MD 20993
`www.fda.gov
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`
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`Reference ID: 4857491
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`

`

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` NDA 022253/S-051
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` NDA 022254/S-041
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` NDA 022255/S-033
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` Page 3
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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, call Stephanie N. Parncutt, M.H.A., Senior Regulatory Health
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`
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`Project Manager, at (301) 796-4098 or email at Stephanie.Parncutt@fda.hhs.gov.
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`Sincerely,
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`{See appended electronic signature page}
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`
`Alice Hughes, M.D.
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`Deputy Director for Safety
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`Division of Neurology 2
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`Office of Neuroscience
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`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
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`• Content of Labeling
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`o Prescribing Information
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`o Medication Guide
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`
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`Reference ID: 4857491
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`

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`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`ALICE HUGHES
`09/15/2021 12:47:43 PM
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`Reference ID: 4857491
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`(
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