`
`NDAs: See Attached List
`
`SUPPLEMENT APPROVAL
`
`
`
`UCB, Inc.
`Attention: Lara Duffney, PhD
`Regulatory Scientist
`4000 Paramount Parkway
`Suite 200
`Morrisville, NC 27560
`
`
`
`Dear Dr. Duffney:
`
`
`Please refer to your supplemental New Drug Application(s) (sNDA) submitted under
`section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA), and all
`amendments, for the following products:
`
`
`FDA
`Received
`Date
`November
`19, 2021
`November
`19, 2021
`November
`19, 2021
`
`Supplemental Application Product Information
`
`Submit Date
`
`NDA 022254/S-044
`
`NDA 022253/S-054
`
`NDA 022255/S-036
`
`Vimpat (lacosamide)
`Injection
`Vimpat (lacosamide)
`Tablets
`Vimpat (lacosamide)
`Oral Solution
`
`November
`19, 2021
`November
`19, 2021
`November
`19, 2021
`
`
`
`These “Changes Being Effected” supplemental new drug applications provide for an
`update to the “United States Prescribing Information” (USPI) in response to a CBE-0
`Supplement Request regarding the ingredient statement for Vimpat Injection. Also,
`updates to the “USPI”, Medication Guide, and Vimpat Injection carton labeling to include
`the quantity or function of two inactive ingredients present in Vimpat Injection.
`
`
`APPROVAL & LABELING
`
`
`We have completed our review of these supplemental applications, as amended. They
`are approved, effective on the date of this letter, for use as recommended in the
`enclosed agreed-upon labeling.
`
`
`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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
`Content of labeling must be identical to the enclosed labeling (text for the prescribing
`U.S. Food & Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`
`
`NDAs: See Attached List
`Page 2
`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 titled SPL Standard for Content of Labeling Technical Qs and As at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guida
`nces/UCM072392.pdf.
`
`The SPL will be accessible via 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 MS Word format,
`that includes the changes approved in these supplemental applications, 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).
`
`
`CARTON AND CONTAINER LABELS
`
`
`Submit final printed carton and container labels that are identical to carton and container
`labels submitted on May 17, 2022, 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 – Certain
`Human Pharmaceutical Product Applications and Related Submissions Using the eCTD
`Specifications. For administrative purposes, designate this submission “Product
`Correspondence – Final Printed Carton and Container Labels for approved NDA
`022254/S-044.” Approval of this submission by FDA is not required before the labeling
`is used.
`
`
`REPORTING REQUIREMENTS
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`
`
`
`
`
`
`
`
`
`
`U.S. Food & Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`
`
`NDAs: See Attached List
`Page 3
`
`If you have any questions, call Avani Patel, Regulatory Business Process Manager, at
`(240) 402 - 1845.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Gurpreet Gill-Sangha, Ph.D.
`Branch Chief, Branch 3
`Division of Post-Marketing Activities I
`Office of Lifecycle Drug Products
`Office of Pharmaceutical Quality
`Center for Drug Evaluation and Research
`
`
`
`
`Enclosure:
`
`
`Content of Labeling
`
`U.S. Food & Drug Administration
`Silver Spring, MD 20993
`www.fda.gov
`
`
`
`Gurpreet
`Gill Sangha
`
`Digitally signed by Gurpreet Gill Sangha
`Date: 5/19/2022 09:27:40AM
`GUID: 5135f2ad000117842392c50c36c7f28a
`
`