`
`
` NDA 22253/S-46 and S-48
`
` NDA 22254/S-36 and S-38
`
`NDA 22255/S-27 and S-30
`
`
`
`
`
`SUPPLEMENT APPROVAL
`
`FULFILLMENT OF POSTMARKETING REQUIREMENT
`
`
`
`
`UCB, Inc.
`
`
`Attention: Justin Franklin, PharmD
`
`
`US Regulatory Science Lead
`
`1950 Lake Park Drive, Building 2100
`
`Smyrna, GA 30080
`
`
`
`Dear Dr. Franklin:
`
`
`
`
`Please refer to your supplemental new drug applications (sNDAs), and your
`
`
`
`amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
`
`
`
`Act (FDCA) for:
`
`
`
` Application
`
`
`
`
`
`
`
`
`
` Product
`
`
`
`
`NDA 22253/S-046
`
`NDA 22254/S-036
`
`NDA 22255/S-027
`
`
`
`Vimpat (lacosamide) tablets
`
`Vimpat (lacosamide) injection
`
`Vimpat (lacosamide) oral solution
`
`
`
`NDA 22254/S-038
`
`
`
`
`Vimpat (lacosamide) injection
`
`
`Reference ID: 4702000
`
`
`Submitted and
`received on:
`
`
`
`
` Provides for:
`
`
`
`
`
`
`
`January 16, 2020 The addition of a new
`indication for adjunctive
`therapy in the treatment of
`primary generalized tonic­
`
`
`clonic seizures in patients 4
`
`
`
`years of age and older.
`
`
`The expansion of the
`intravenous (iv) use of
`
`lacosamide for the treatment
`of partial onset seizures in
`
`
`patients 4 to less than 17
`
`years of age.
`
`
`
`
`April 30, 2020
`
`

`

`
` NDA 22253/S-046 and S-048
`
` NDA 22254/S-036 and S-038
`
`NDA 22255/S-027 and S-030
`
` Page 2
`
`
`
`
`
` NDA 22253/S-048
`
` NDA 22255/S-030
`
`
`
` Vimpat (lacosamide) tablets
`
`
` Vimpat (lacosamide) oral solution
`
`
`
`
` April 30, 2020
`
`
`
`
`
`
`
`
`
`
`
`
` The incorporation (by cross-
`
` reference) of labeling revisions
`provided in NDA 022254/S­
` 038 into the tablets and oral
`
`solution labeling as the
`approved labeling for all three
`NDAs is contained with the
`same full prescribing
`
`information.
`
`
`
`
`
` 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.
`
` WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
`
`
`Please note that we have previously granted a waiver of the requirements of 21 CFR
`
`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
`
`
`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 these NDAs, including CBE supplements for which FDA has not yet issued
`
`
`
` 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: 4702000
`
`

`

`
` NDA 22253/S-046 and S-048
`
` NDA 22254/S-036 and S-038
`
`NDA 22255/S-027 and S-030
`
` Page 3
`
`
`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 these supplemental applications, 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).
`
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
`
`
`new active ingredients (which includes new salts and new fixed combinations), new
`
`
`indications, new dosage forms, new dosing regimens, or new routes of administration
`
`are required to contain an assessment of the safety and effectiveness of the product for
`
`
`the claimed indication in pediatric patients unless this requirement is waived, deferred,
`
`or inapplicable.
`
`
`Primary Generalized Tonic-Clonic Seizures (PGTCS) Supplements (NDA 22253/S­
`
`
`046, NDA 22254/S-036, and NDA 22255/S-027):
`
`
`
`We are waiving the pediatric study requirement for less than 4 years of age because
`
`
`
`necessary studies are impossible or highly impracticable. This is because the
`
`diagnosis is rare prior to 6 years of age and, when it is diagnosed prior to age 4 years of
`
`
`
`age, it is generally more responsive to currently available treatments, and does not
`
`become refractory until later in its course.
`
`
`
`We are deferring submission of your pediatric studies of the use of oral and intravenous
`
`
`loading doses for ages 4 to less than 17 years for this application because this product
`
`
`
`
`
`
`is ready for approval for use in adults and these pediatric studies have not been
`
`
`
`completed. Your deferred pediatric studies required by section 505B(a) of the FDCA are
`
`
`
`required postmarketing studies. The status of these postmarketing studies must be
`
`
`
`reported annually according to 21 CFR 314.81 and section 505B(a)(4)(C) of the FDCA.
`
`
`These required studies are listed below.
`
`
`
`
`
`
`3957-1 A study that will examine safety and tolerability of an oral loading dose of
`
`
`
`Vimpat (lacosamide) that will allow a more rapid achievement of the final
`
`
`
`
`recommended therapeutic dose in pediatric patients 4 to <17 years of age.
`
`
`
`
`
`
`09/2020
`
`Study Completion:
`
`
`Final Report Submission: 03/2021
`
`
`
`
`
`3957-2 A study that will examine safety and tolerability of an intravenous loading
`
`dose of Vimpat (lacosamide) that will allow a more rapid achievement of
`
`
`
`
`
`U.S. Food and Drug Administration
`
`
`
`
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`Reference ID: 4702000
`
`

`

`
` NDA 22253/S-046 and S-048
`
` NDA 22254/S-036 and S-038
`
`NDA 22255/S-027 and S-030
`
` Page 4
`
`
`
`steady-state exposures of the final recommended therapeutic dose in
`
`pediatric patients 4 to <17 years of age.
`
`
`
`
`
`09/2020
`
`Study Completion:
`
`
`Final Report Submission: 03/2021
`
`
`
`
`
`
`
`
`
`
`
`
`
` Reports of these required pediatric postmarketing studies must be submitted as a new
`
`
`
`
` drug application (NDA) or as a supplement to your approved NDA with the proposed
`
` labeling changes you believe are warranted based on the data derived from this study.
` When submitting the reports, please clearly mark your submission "SUBMISSION OF
`
`
`REQUIRED PEDIATRIC ASSESSMENTS" in large font, bolded type at the beginning of
`
`
` the cover letter of the submission.
`
` This product is appropriately labeled for use in ages 4 years and older for adjunctive
`
`
`
` therapy in the treatment of PGTCS for all Vimpat formulations.
`
`
` Partial Onset Seizure (POS) Supplements (NDA 22253/S-048, NDA 22254/S-038,
`
` and NDA 22255/S-030):
`
` We note that you have fulfilled the pediatric study requirement for ages 4 to less than 17
`
`
` years for Vimpat (lacosamide) injection.
`
` FULFILLMENT OF POSTMARKETING REQUIREMENT
`
`We refer to your sNDA submitted under section 505(b) of the FDCA for Vimpat
`
`
`(lacosamide) injection (NDA 22254/S-038).
`
`
`
`We have received your submission dated April 30, 2020, containing the final report for
`
`the following postmarketing requirement listed in the November 3, 2017, approval letter.
`
`
`
`
`3293-2
`
`
`
`We have reviewed your submission and conclude that the above requirement was
`
`
`
`
`fulfilled.
`
`
`We remind you that there are postmarketing requirements listed in the August 29, 2014,
`
`and November 3, 2017, 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
`
`
`
`
`
`
`
`Deferred pediatric studies under PREA for the treatment of partial-onset
`
`
`seizures in pediatric patients ages 4 years to <17 years.
`
`
`
`U.S. Food and Drug Administration
`
`
`
`
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`Reference ID: 4702000
`
`

`

`
` NDA 22253/S-046 and S-048
`
` NDA 22254/S-036 and S-038
`
`NDA 22255/S-027 and S-030
`
` Page 5
`
`
`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
`
`
`Electronic Format-Promotional Labeling and Advertising Materials for Human
`
`Prescription Drugs.3
`
`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 Stephanie.Parncutt@fda.hhs.gov.
`
`
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`Nick Kozauer, MD
`
`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
`
`
`
`
`
`
`
`
` 3 For the most recent version of a guidance, check the FDA guidance web page at
`
`
`
` https://www.fda.gov/media/128163/download.
`
`
` 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: 4702000
`
`

`

`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
`11/16/2020 10:46:20 AM
`
`Reference ID: 4702000
`
`(
`
`
`
`