`
`g _/CDEPARTNIENTOFHEALTHANDHUMANSERVICES
`‘9
`«Q
`
`NDA 022253/8-042
`
`NDA 022254/S-033
`
`NDA 022255/3-024
`
`UCB, Inc.
`
`Attention: Laila El—Asmar, PhD.
`Associate Director, Regulatory Affairs
`1950 Lake Park Drive
`
`Building 2100
`Smyrna, GA 30080
`
`Dear Dr. El—Asmar:
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`SUPPLENIENT APPROVAL
`
`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:
`
`A . nlication
`
`Product Name
`
`Submitted & received on:
`
`Vimpat (lacosamide) oral solution
`
`NDA 022253/S-042
`
`Vimpat (lacosamide) tablets
`
`NDA 022254/S—033
`
`Vimpat (lacosamide) injection
`
`May 11, 2018
`
`NDA 022255/S—024
`
`These Prior Approval supplemental new drug applications provide for revisions to the Warnings
`and Precautions (Section 5.3—Cardiac Rhythm and Conduction Abnormalities), Dosage and
`Administration, Drug Interactions, Overdosage, and Patient Counseling Information sections of
`the Prescribing Information, as well as the Medication Guide, to reflect new information related
`to the risk for serious cardiac events (e.g., cardiac arrest, asystole, ahioventricular block, and
`ventricular arrhythmias). In addition, these Prior Approval supplemental new drug applications
`provide for revisions to Section 5.6 (Warnings and Precautions; Drug Reaction with Eosinophilia
`and Systemic Symptoms [DRESS]/Multi—Organ Hypersensitivity) to reflect that DRESS has
`been reported in patients treated with Vimpat and to provide greater consistency with the
`language related to the risk for DRESS in other antiepileptic drug labels.
`
`APPROVAL & LABELING
`
`We have completed our review of these supplemental applications. They are approved, effective
`on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
`
`Reference ID: 4348497
`
`
`
`NDA 022253/S-042
`NDA 022254/S-033
`NDA 022255/S-024
`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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. 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 titled
`“SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
`
`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 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).
`
`REPORTING REQUIREMENTS
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 4348497
`
`
`
`NDA 022253/S-042
`NDA 022254/S-033
`NDA 022255/S-024
`Page 3
`
`
`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}
`
`Alice Hughes, M.D.
`Deputy Director for Safety
`Division of Neurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`ENCLOSURE(S):
`Content of Labeling
`Prescribing Information
`Medication Guide
`
`
`
`Reference ID: 4348497
`
`
`
`NDA 022253/S-042
`NDA 022254/S-033
`NDA 022255/S-024
`Page 4
`
`
`
`
`Reference ID: 4348497
`
`
`
`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
`11/11/2018
`
`Reference ID: 4348497
`
`(
`
`
`
`
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