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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`
`
`
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`Food and Drug Administration
`
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
`
`
`
`NDA 22-253/S-004
`NDA 22-254/S-001
`
`Schwarz Biosciences, Inc.
`Attention: Susan Tegtmeyer, M. S.
`Senior Manager Regulatory Affairs
`1950 Lake Park Drive
`Smyrna, GA 30080
`
`
`Dear Ms. Tegtmeyer:
`
`Please refer to your supplemental new drug applications dated May 21, 2009, received
`May 22, 2009, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for Vimpat (lacosamide) Tablets and Injection.
`
`These “Changes Being Effected” supplemental new drug applications provide for revision of the
`package insert to reflect the scheduling of VIMPAT (CV) under the Controlled Substances Act.
`
`We have completed our review of this application and it is approved, effective on the date of this
`letter, for use as recommended in the enclosed, agreed upon labeling text, which is identical to
`the content of labeling [21 CFR 314.50(l)(1)(i)] in structured product labeling (SPL) format
`submitted on May 21, 2009.
`
`CONTENT OF LABELING
`
`
`We note that your May 21, 2009 submission includes final printed labeling (FPL) for your
`package insert and Medication Guide. We have not reviewed this FPL. You are responsible for
`assuring that the wording in this printed labeling is identical to that of the approved content of
`
`labeling in the structured product labeling (SPL) format.
`
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
`proposed materials in draft or mock-up form with annotated references, and the package insert(s)
`to:
`
`
`Food and Drug Administration
`
`Center for Drug Evaluation and Research
`
`Division of Drug Marketing, Advertising, and Communications
`
`5901-B Ammendale Road
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`
`
`
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` NDA 22-253/S-004
`
` NDA 22-254/S-001
`Page 2
`
`Beltsville, MD 20705-1266
`
`
`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`package insert(s), at the time of initial dissemination or publication, accompanied by a Form
`
`FDA 2253. For instruction on completing the Form FDA 2253, see page 2 of the Form. For
`more information about submission of promotional materials to the Division of Drug Marketing,
`Advertising, and Communications (DDMAC), see
`http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
`
`LETTERS TO HEALTH CARE PROFESSIONALS
`
`
`If you issue a letter communicating important safety related information about this drug product
`(i.e., a “Dear Health Care Professional” letter), we request that you submit an electronic copy of
`the letter to both this NDA and to the following address:
`
`
`
`MedWatch
`
`Food and Drug Administration
`
`5600 Fishers Lane, Room 12B05
`
`Rockville, MD 20857
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`
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`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 Susan Daugherty, Regulatory Project Manager, at
`(301) 796-0878.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`Russell Katz, M.D.
`Director
`
`Division of Neurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`
`Enclosure: Content of Labeling
`
`
`
`
`Application
`Type/Number
`--------------------
`NDA-22253
`
`Submission
`Type/Number
`--------------------
`SUPPL-4
`
`NDA-22254
`
`SUPPL-1
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`Submitter Name
`
`Product Name
`
`--------------------
`SCHWARZ
`BIOSCIENCES INC
`SCHWARZ
`BIOSCIENCES INC
`
`------------------------------------------
`VIMPAT
`
`VIMPAT
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`RUSSELL G KATZ
`11/18/2009
`
`
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