` NDA 022253/S-049
`
` NDA 022254/S-039
`
`NDA 022255/S-031
`
`
`
`SUPPLEMENT APPROVAL
`
`
` UCB, Inc.
`
` Attention: Kelly Roney, Ph.D., RAC
`
`
` US Regulatory Science Team Lead, Epilepsies America
` 4000 Paramount Parkway, Suite 200
`
`
` Morrisville, NC 27560
`
`
`Dear Dr. Roney:
`
`
`
`
`
`Please refer to your supplemental new drug applications (sNDAs) submitted under
`
`
`
`
`section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for the following:
`
`
`
`
`
`Application
`NDA 022253/S­
`
` 049
`NDA 022254/S­
`
` 039
`NDA 022255/S­
`
` 031
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Submitted on:
`Product Name
`
` December 15,
` Vimpat (lacosamide)
`
`
` Tablets
` 2020
` December 15,
` Vimpat (lacosamide)
`
`
` Injection
` 2020
` December 15,
` Vimpat (lacosamide)
`
`
` Oral Solution
` 2020
` These Prior Approval supplements propose:
`
`
`
`
`
`
` The use of lacosamide for oral and intravenous monotherapy and adjunctive therapy
` in the treatment of partial onset seizure patients ≥1 month to <4 years of age.
`
`
`
`
`
`
`
`
`
`
`
`
` Increase of in-use shelf-life for oral solution from 7-weeks to 6-months to support
`
` proposed indication in partial onset seizure patients ≥1 month to <4 years of age.
`
`
`
`
`
`
`
`
`
`Received on:
`
` December 15,
`
` 2020
` December 15,
`
` 2020
` December 15,
`
` 2020
`
`
`
`
`
`
`
`
` APPROVAL & LABELING
`
`We have completed our review of these applications, as amended. They are approved,
`
`
`
`
`
`effective on the date of this letter, for use as recommended in the enclosed agreed-
`
`upon labeling.
`
`
`
`
`Reference ID: 4872128
`
`

`

`
`
`
` NDA 022253/S-049
`
` NDA 022254/S-039
`
`
`NDA 022255/S-031
`
` Page 2
`
`
` CONTENT OF LABELING
`
`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
`
`
`
`
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`
`
`Prescribing Information 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.
`
`
`Information on submitting SPL files using eList may be found in the guidance for
`
`
`industry SPL Standard for Content of Labeling Technical Qs and As.2
`
`
`
`
`The SPL will be accessible from publicly available labeling repositories.
`
`
`
`
`Also within 14 days, amend all pending supplemental applications that include 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 Microsoft Word
`
`
`
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. To facilitate review of your submission(s), 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).
`
`
`CARTON AND CONTAINER LABELING
`
`
`
`
`
`
`Submit the final printed container label that is identical to the container label submitted
`
`
`
`
`
`
`on June 8, 2021, as soon as it is available, but no more than 30 days after it is printed.
`
`
`
`Please submit this labeling electronically according to the guidance for industry
`
`
`Providing Regulatory Submissions in Electronic Format — Certain Human
`
`
`Pharmaceutical Product Applications and Related Submissions Using the eCTD
`Specifications. For administrative purposes, designate this submission “Final Printed
`
`
`Carton and Container Labeling for approved NDA 022255/S-031.” Approval of this
`
`
`
`submission by FDA is not required before the labeling is used.
`
`
`FULFILLMENT OF POSTMARKETING REQUIREMENTS
` We refer to your sNDAs submitted under section 505(b) of the Federal Food, Drug, and
`
`
` Cosmetic Act (FDCA) for Vimpat (lacosamide) Tablets, Vimpat (lacosamide) Injection,
`
`
`
`
`
` and Vimpat (lacosamide) Oral Solution.
`
`
`
`
`
` 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
`
`
` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`
`
`
`U.S. Food and Drug Administration
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`
`
`Reference ID: 4872128
`
`

`

`
` NDA 022253/S-049
`
` NDA 022254/S-039
`
`
`NDA 022255/S-031
`
` Page 3
`
`
`
`We have received your submission dated December 15, 2020, containing the final
`
`reports for the following postmarketing requirements listed in the October 28, 2008, and
`
`August 29, 2014, approval letters.
`
`
`
`
` 3288-1
`
` A prospective, randomized, controlled, double-blind, efficacy,
`
`
`
` pharmacokinetics and safety study of the adjunctive use of lacosamide for
` the treatment of partial onset seizures in children ages 1 month to < 4
`
`
`
` years. The primary efficacy endpoint must examine seizure frequency
` based upon Video/EEG data. Safety must be evaluated during the
`
`
`
`
`
` controlled study and with a long-term safety extension. At least 50% of
` children in the study should be < 2 years old. A pharmacokinetic analysis
`
`
` must also be performed to determine a dosing regimen for the
`
` monotherapy use of lacosamide in pediatric patients ages 1 month to < 4
`
`
` years of age.
`
`
`
`
`
`
`
` 3293-1
`
`
`
`
` 2774-1
`
`
`
`
`
` Deferred pediatric studies under PREA for the treatment of partial onset
`
`
`
`
`
` seizures in pediatric patients ages 1 month to < 4 years.
`
` A safety study of replacement of oral dosing with intravenous dosing
`
`
`
`
`
`
`
` administered over 30 to 60 minutes in pediatric patients ≥ 1 month to < 17
` years of age with partial onset seizures. If safety is acceptable, a
`
`
`
`
`
` replacement study at a faster rate of infusion (15 minutes) must be
`conducted in this population. Sparse PK samples must be collected to
`evaluate the pharmacokinetics of lacosamide and its metabolite using
`
`
` PPK approach in this population.
`
`
`
`
`
`
`
`
`
`
`
` We have reviewed your submission and conclude that the above requirements were
`
` fulfilled.
`
` We remind you that there are postmarketing requirements listed in the October 28,
`
`2008, and August 29, 2014, approval letters that are still open.
`
`
`
`
`
`
`PROMOTIONAL MATERIALS
`
`
`You may request advisory comments on proposed introductory advertising and
`
`
`promotional labeling. For information about submitting promotional materials, see the
`
`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
`
`
`Electronic Format-Promotional Labeling and Advertising Materials for Human
`
`
`Prescription Drugs.3
`
`
` 3 For the most recent version of a guidance, check the FDA guidance web page at
`
`
`
`
` https://www.fda.gov/media/128163/download.
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`Reference ID: 4872128
`
`

`

`
` NDA 022253/S-049
`
` NDA 022254/S-039
`
`
`NDA 022255/S-031
`
` Page 4
`
`
`
`You must submit final promotional materials and Prescribing Information, accompanied
`
`
`
`by a Form FDA 2253, at the time of initial dissemination or publication
`
`
`
`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
`
`
`
`
`
`
`
`
`
`Instructions for completing the form can be found at FDA.gov.5
`
`
`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 Stephanie N. Parncutt, M.H.A., Senior Regulatory Health
`
`
`
`
`Project Manager, at (301) 796-4098 or email her at Stephanie.Parncutt@fda.hhs.gov.
`
`
`
`
`Sincerely,
`
`
`
`{See appended electronic signature page}
`
`
`Nick Kozauer, M.D.
`
`Director
`
`Division of Neurology 2
`
`Office of Neuroscience
`
`Center for Drug Evaluation and Research
`
`
`
`ENCLOSURE(S):
`
`
`• Content of Labeling
`
`
`o Prescribing Information
`
`
`o Medication Guide
`
`
`
`
`
`
` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`
`
` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`Reference ID: 4872128
`
`

`

`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/
`------------------------------------------------------------
`
`NICHOLAS A KOZAUER
`10/14/2021 11:52:51 AM
`
`Reference ID: 4872128
`
`(
`
`
`
`