CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`
`
`APPLICATION NUMBER:
`022255Orig1s000
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
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`
`
`
`

`

`EXCLUSIVITY SUMMARY
`
`
`NDA # 22-255
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`
`SUPPL #
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`HFD #
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`Trade Name Vimpat oral solution
`
`Generic Name lacosamide
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`Applicant Name Schwarz Biosciences
`
`Approval Date, If Known 4/20/10
`
`PART I
`
`1. An exclusivity determination will be made for all original applications, and all efficacy
`supplements. Complete PARTS II and III of this Exclusivity Summary only if you answer "yes" to
`one or more of the following questions about the submission.
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`IS AN EXCLUSIVITY DETERMINATION NEEDED?
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`a) Is it a 505(b)(1), 505(b)(2) or efficacy supplement?
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` YES
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`If yes, what type? Specify 505(b)(1), 505(b)(2), SE1, SE2, SE3,SE4, SE5, SE6, SE7, SE8
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`NO
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`505(b)(1)
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`c) Did it require the review of clinical data other than to support a safety claim or change in
`labeling related to safety? (If it required review only of bioavailability or bioequivalence
`data, answer "no.")
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` YES
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`NO
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`If your answer is "no" because you believe the study is a bioavailability study and, therefore,
`not eligible for exclusivity, EXPLAIN why it is a bioavailability study, including your
`reasons for disagreeing with any arguments made by the applicant that the study was not
`simply a bioavailability study.
`
`
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`If it is a supplement requiring the review of clinical data but it is not an effectiveness
`supplement, describe the change or claim that is supported by the clinical data:
`
`
`The study SP657 is entitled “Randomized, open, 2-period crossover trial to show bioequivalence
`following single oral dosing of a tablet and of a liquid of 200 mg SPM 927 each in healthy
`subjects”
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`Page 1
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`d) Did the applicant request exclusivity?
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`If the answer to (d) is "yes," how many years of exclusivity did the applicant request?
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` YES
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`NO
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`e) Has pediatric exclusivity been granted for this Active Moiety?
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` YES
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`NO
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`no
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` If the answer to the above question in YES, is this approval a result of the studies submitted in
`response to the Pediatric Written Request?
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`
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`IF YOU HAVE ANSWERED "NO" TO ALL OF THE ABOVE QUESTIONS, GO DIRECTLY TO
`THE SIGNATURE BLOCKS AT THE END OF THIS DOCUMENT.
`
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`2. Is this drug product or indication a DESI upgrade?
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` YES
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`NO
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`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
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` YES
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`NO
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`IF THE ANSWER TO QUESTION 2 IS "YES," GO DIRECTLY TO THE SIGNATURE BLOCKS
`ON PAGE 8 (even if a study was required for the upgrade).
`
`
`FIVE-YEAR EXCLUSIVITY FOR NEW CHEMICAL ENTITIES
`PART II
`(Answer either #1 or #2 as appropriate)
`
`1. Single active ingredient product.
`
`Has FDA previously approved under section 505 of the Act any drug product containing the same
`active moiety as the drug under consideration? Answer "yes" if the active moiety (including other
`esterified forms, salts, complexes, chelates or clathrates) has been previously approved, but this
`particular form of the active moiety, e.g., this particular ester or salt (including salts with hydrogen or
`coordination bonding) or other non-covalent derivative (such as a complex, chelate, or clathrate) has
`not been approved. Answer "no" if the compound requires metabolic conversion (other than
`deesterification of an esterified form of the drug) to produce an already approved active moiety.
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`Page 2
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`NDA# 22-253
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`NDA# 22-254
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`NDA#
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`Vimpat (lacosamide) Tablets
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`Vimpat (lacosamide) Injection
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`If "yes," identify the approved drug product(s) containing the active moiety, and, if known, the NDA
`#(s).
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`NDA#
`NDA#
`NDA#
`
`
`IF THE ANSWER TO QUESTION 1 OR 2 UNDER PART II IS "NO," GO DIRECTLY TO THE
`SIGNATURE BLOCKS ON PAGE 8. (Caution: The questions in part II of the summary should
`only be answered “NO” for original approvals of new molecular entities.)
`IF “YES,” GO TO PART III.
`
`
`PART III
`
`To qualify for three years of exclusivity, an application or supplement must contain "reports of new
`clinical investigations (other than bioavailability studies) essential to the approval of the application
`and conducted or sponsored by the applicant." This section should be completed only if the answer
`to PART II, Question 1 or 2 was "yes."
`
`
`1. Does the application contain reports of clinical investigations? (The Agency interprets "clinical
`investigations" to mean investigations conducted on humans other than bioavailability studies.) If
`the application contains clinical investigations only by virtue of a right of reference to clinical
`
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`
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`2. Combination product.
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`If the product contains more than one active moiety(as defined in Part II, #1), has FDA previously
`approved an application under section 505 containing any one of the active moieties in the drug
`product? If, for example, the combination contains one never-before-approved active moiety and
`one previously approved active moiety, answer "yes." (An active moiety that is marketed under an
`OTC monograph, but that was never approved under an NDA, is considered not previously
`approved.)
`
`YES
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`NO
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`THREE-YEAR EXCLUSIVITY FOR NDAs AND SUPPLEMENTS
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`Page 3
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`investigations in another application, answer "yes," then skip to question 3(a). If the answer to 3(a)
`is "yes" for any investigation referred to in another application, do not complete remainder of
`summary for that investigation.
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`YES
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`NO
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`IF "NO," GO DIRECTLY TO THE SIGNATURE BLOCKS ON PAGE 8.
`
`2. A clinical investigation is "essential to the approval" if the Agency could not have approved the
`application or supplement without relying on that investigation. Thus, the investigation is not
`essential to the approval if 1) no clinical investigation is necessary to support the supplement or
`application in light of previously approved applications (i.e., information other than clinical trials,
`such as bioavailability data, would be sufficient to provide a basis for approval as an ANDA or
`505(b)(2) application because of what is already known about a previously approved product), or 2)
`there are published reports of studies (other than those conducted or sponsored by the applicant) or
`other publicly available data that independently would have been sufficient to support approval of
`the application, without reference to the clinical investigation submitted in the application.
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` YES
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`NO
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` If yes, explain:
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`(2) If the answer to 2(b) is "no," are you aware of published studies not conducted or
`sponsored by the applicant or other publicly available data that could independently
`demonstrate the safety and effectiveness of this drug product?
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`Page 4
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`(a) In light of previously approved applications, is a clinical investigation (either conducted
`by the applicant or available from some other source, including the published literature)
`necessary to support approval of the application or supplement?
`
`
` YES
`
`
`If "no," state the basis for your conclusion that a clinical trial is not necessary for approval
`AND GO DIRECTLY TO SIGNATURE BLOCK ON PAGE 8:
`
`
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`NO
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`
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`(b) Did the applicant submit a list of published studies relevant to the safety and effectiveness
`of this drug product and a statement that the publicly available data would not independently
`support approval of the application?
`
`
`(1) If the answer to 2(b) is "yes," do you personally know of any reason to disagree
`with the applicant's conclusion? If not applicable, answer NO.
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` YES
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`NO
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`

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` If yes, explain:
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` YES
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`NO
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`Studies comparing two products with the same ingredient(s) are considered to be bioavailability
`studies for the purpose of this section.
`
`
`3. In addition to being essential, investigations must be "new" to support exclusivity. The agency
`interprets "new clinical investigation" to mean an investigation that 1) has not been relied on by the
`agency to demonstrate the effectiveness of a previously approved drug for any indication and 2) does
`not duplicate the results of another investigation that was relied on by the agency to demonstrate the
`effectiveness of a previously approved drug product, i.e., does not redemonstrate something the
`agency considers to have been demonstrated in an already approved application.
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`(c)
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`If the answers to (b)(1) and (b)(2) were both "no," identify the clinical investigations
`submitted in the application that are essential to the approval:
`
`
`
`a) For each investigation identified as "essential to the approval," has the investigation been
`relied on by the agency to demonstrate the effectiveness of a previously approved drug
`product? (If the investigation was relied on only to support the safety of a previously
`approved drug, answer "no.")
`
`Investigation #1
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`Investigation #2
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`YES
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`YES
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`NO
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`NO
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`If you have answered "yes" for one or more investigations, identify each such investigation
`and the NDA in which each was relied upon:
`
`
`
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`b) For each investigation identified as "essential to the approval", does the investigation
`duplicate the results of another investigation that was relied on by the agency to support the
`effectiveness of a previously approved drug product?
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`Investigation #1
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`Investigation #2
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`YES
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`YES
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`NO
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`NO
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`Page 5
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`

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`
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`If you have answered "yes" for one or more investigation, identify the NDA in which a
`similar investigation was relied on:
`
`
`
`c) If the answers to 3(a) and 3(b) are no, identify each "new" investigation in the application
`or supplement that is essential to the approval (i.e., the investigations listed in #2(c), less any
`that are not "new"):
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`4. To be eligible for exclusivity, a new investigation that is essential to approval must also have
`been conducted or sponsored by the applicant. An investigation was "conducted or sponsored by"
`the applicant if, before or during the conduct of the investigation, 1) the applicant was the sponsor of
`the IND named in the form FDA 1571 filed with the Agency, or 2) the applicant (or its predecessor
`in interest) provided substantial support for the study. Ordinarily, substantial support will mean
`providing 50 percent or more of the cost of the study.
`
`
`Investigation #1
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`IND #
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`YES
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`Investigation #2
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`a) For each investigation identified in response to question 3(c): if the investigation was
`carried out under an IND, was the applicant identified on the FDA 1571 as the sponsor?
`
`!
`!
`
`! NO
`! Explain:
`
`
`
`!
`!
`
`! NO
`! Explain:
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`YES
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`IND #
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`(b) For each investigation not carried out under an IND or for which the applicant was not
`identified as the sponsor, did the applicant certify that it or the applicant's predecessor in
`interest provided substantial support for the study?
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`Page 6
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`
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`Investigation #1
`
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`YES
`Explain:
`
`
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`Investigation #2
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`YES
`
`Explain:
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`!
`!
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`! NO
`! Explain:
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`!
`!
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`! NO
`! Explain:
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`(c) Notwithstanding an answer of "yes" to (a) or (b), are there other reasons to believe that
`the applicant should not be credited with having "conducted or sponsored" the study?
`(Purchased studies may not be used as the basis for exclusivity. However, if all rights to the
`drug are purchased (not just studies on the drug), the applicant may be considered to have
`sponsored or conducted the studies sponsored or conducted by its predecessor in interest.)
`
`
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`YES
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`
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`NO
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`
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`If yes, explain:
`
`
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`
`
`=================================================================
`
`Name of person completing form:
`Title:
`Date:
`
`
`Name of Office/Division Director signing form:
`Title:
`
`
`
`Form OGD-011347; Revised 05/10/2004; formatted 2/15/05
`
`
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`Page 7
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`

`

`Application
`Type/Number
`--------------------
`NDA-22255
`
`Submission
`Type/Number
`--------------------
`ORIG-1
`
`Submitter Name
`
`Product Name
`
`--------------------
`SCHWARZ
`BIOSCIENCES INC
`
`------------------------------------------
`VIMPAT
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`SUSAN B DAUGHERTY
`05/03/2010
`
`RUSSELL G KATZ
`05/03/2010
`
`

`

`
`
`
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`
`
`NDA 22-253/S-006, 22-254/ S-003, and 22-255
`
`INFORMATION REQUEST
`
`
`
`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 (sNDAs) submitted under section 505(b) of
`the Federal Food, Drug, and Cosmetic Act (FDCA) for Vimpat (lacosamide) Tablets (NDA 22-
`253/
`), and Injection (NDA 22-254/
`.
`
`Please also refer to your New Drug Application (NDA) submitted under section 505(b) of the FDCA
`for Vimpat (lacosamide) Oral Solution, 10 mg/ml (NDA 22-255).
`
`We are reviewing your submissions and have the following comments and requirements. We request
`a prompt written response in order to continue our evaluation.
`
`RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
`
`The REMS for Vimpat (lacosamide) Tablets and Injection was approved on October 28, 2008. The
`REMS consists of a Medication Guide and a timetable for submission of assessments of the REMS.
`
`Please refer to our letter dated January 11, 2010, notifying you that we have determined that a REMS
`is also necessary for Vimpat (lacosamide) Oral Solution. Vimpat (lacosamide) Oral Solution will
`share a Medication Guide with Vimpat (lacosamide) Tablets and Injection, and the elements of the
`REMS are the same for all three products. Therefore, all three formulations of lacosamide will be
`included in one REMS.
`
`We consider the addition of the oral solution formulation to be “new safety information” as defined in
`section 505-1(b) of FDCA. Therefore, in accordance with section 505-1(g)(2)(C) of the FDCA, we
`have determined that your approved REMS for Vimpat Tablets and Injection must be modified to
`include Vimpat Oral Solution. We acknowledge submission of your proposed modified REMS on
`August 21, 2009; however, the submission was not complete and must include the following:
`
`1. Your REMS document approved on October 28, 2008, revised as follows: (see attached
`REMS Appendix A)
`o Include all three formulations of lacosamide
`
`
`
`
`(b) (4)
`
`(b) (4)
`
`

`

`NDA 22-253/S-006, 22-254/ S-003, and 22-255
`Page 2
`
`
`
`o The dates in the timetable for submission of assessments of your REMS will remain
`the same as was approved in your original REMS on October 28, 2008. Please note
`that your REMS modification should include the most current template language as
`follows:
`
`
`
`
`
`
`
`“COMPANY will submit REMS Assessments to the FDA by 18 months, by 3
`years and in the 7th year from the date of original approval of the REMS. To
`facilitate inclusion of as much information as possible while allowing
`reasonable time to prepare the submission, the reporting interval covered by
`each assessment should conclude no earlier than 60 days before the submission
`date for that assessment. COMPANY will submit each assessment so that it
`will be received by the FDA on or before the due date.”
`
`
`
`2. A revised comprehensive Medication Guide that includes all formulations of lacosamide
`
`o We refer to your proposed comprehensive Medication Guide submitted on August 21,
`2009. Comments on your proposed comprehensive Medication Guide were sent to
`you in an email correspondence on March 17, 2010. The Medication Guide that you
`submit with your proposed REMS modification should address our comments and
`revisions.
`
`
`3. A revised REMS supporting document (see attached REMS Appendix B)
`
`o Updates to the REMS supporting document may be included in a new document that
`references previous REMS supporting document submissions for unchanged portions
`of the REMS, or updates may be made by modifying the complete previous REMS
`supporting document, with all changes marked and highlighted.
`
`
` 4. An assessment of the approved REMS
`
`
`o Under section 505-1(g)(2)(C) of the FDCA, when the Agency determines that the
`REMS should be modified, the NDA holder is required to assess the REMS. Where
`the NDA holder agrees with the Agency's proposed modification to a REMS that
`consists solely of a Medication Guide, that assessment may consist of a statement that
`the Medication Guide would be adequate with the proposed modifications to achieve
`its purpose.
`
`
`
`Prominently identify the submission containing your REMS assessments and proposed modifications
`with the following wording in bold capital letters at the top of the first page of the submission:
`
`
`
` and NDA 22-254
`NDA 22-253
`PROPOSED REMS MODIFICATION- AMENDMENT
`REMS ASSESSMENT
`
`
`
`
`
`
`(b) (4)
`
`(b) (4)
`
`

`

`NDA 22-253/S-006, 22-254/ S-003, and 22-255
`Page 3
`
`
`TIMETABLE FOR SUBMISSION OF ASSESSMENTS FOR REMS
`
`The timetable for submission of assessments in the REMS approved on October 28, 2008, for Vimpat
`(lacosamide) Tablets and Injection requires an April 2010 assessment of the REMS. We
`acknowledge, however, that subsequent to our initial requirement for a REMS for lacosamide, we
`determined that all members of the anti-epileptic drug (AED) class, including lacosamide, should
`have individual Medication Guides that include all risk information that is necessary for patients’ safe
`and effective use of each drug, including but not limited to the increased risk of suicidal thoughts and
`behavior. Thus, the REMS assessment due by April 2010 may consist of a statement that the
`Medication Guide would be adequate to achieve its purpose.
`
`In addition, the assessment must also include, as required under section 505-1(g)(3)(B) and (C) of
`FDCA, information on the status of any postapproval study or clinical trial required under section
`505(o) or otherwise undertaken to investigate a safety issue. With respect to any postapproval study,
`you must include the status of such study, including whether any difficulties completing the study
`have been encountered. With respect to any postapproval clinical trial, you must include the status of
`such clinical trial, including whether enrollment has begun, the number of participants enrolled, the
`expected completion date, whether any difficulties completing the clinical trial have been
`encountered, and registration information with respect to requirements under subsections (i) and (j) of
`section 402 of the Public Health Service Act. You can satisfy these requirements in your REMS
`assessments by referring to relevant information included in the most recent annual report required
`under section 506B and 21 CFR 314.81(b)(2)(vii) and including any updates to the status information
`since the annual report was prepared. Failure to comply with the REMS assessments provisions in
`section 505-1(g) could result in enforcement action.
`
`If you do not submit electronically, please send 5 copies of your REMS-related submissions.
`
`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
`
`
`
`

`

`NDA 22-253/S-006, 22-254/ S-003, and 22-255
`Page 4
`
`
`Appendix A: Medication Guide REMS Template
`
`
`Application number TRADE NAME (DRUG NAME)
`
`Class of Product as per label
`
`Applicant name
`Address
`Contact Information
`
`
` RISK EVALUATION AND MITIGATION STRATEGY (REMS)
`
`I. GOAL(S):
`
` List the goals and objectives of the REMS.
`
`II. REMS ELEMENTS:
`
`A. Medication Guide
`
`A Medication Guide will be dispensed with each [drug name] prescription. [Describe in detail how
`you will comply with 21 CFR 208.24.]
`
`
`B. Timetable for Submission of Assessments
`
`For products approved under an NDA or BLA, specify the timetable for submission of assessments of
`the REMS. The timetable for submission of assessments shall be no less frequent than by 18 months,
`3 years, and in the 7th year after the REMS is initially approved. You should specify the reporting
`interval (dates) that each assessment will cover and the planned date of submission to the FDA of the
`assessment. To facilitate inclusion of as much information as possible while allowing reasonable
`time to prepare the submission, the reporting interval covered by each assessment should conclude no
`earlier than 60 days before the submission date for that assessment. For example, the reporting
`interval covered by an assessment that is to be submitted by July 31st should conclude no earlier than
`June 1st.
`
`Include the following paragraph in your REMS:
`
`COMPANY will submit REMS Assessments to the FDA by 18 months, by 3 years and in the 7th year
`from the date of original approval of the REMS. To facilitate inclusion of as much information as
`possible while allowing reasonable time to prepare the submission, the reporting interval covered by
`each assessment should conclude no earlier than 60 days before the submission date for that
`assessment. COMPANY will submit each assessment so that it will be received by the FDA on or
`before the due date.
`
`
`
`
`
`

`

`NDA 22-253/S-006, 22-254/ S-003, and 22-255
`Page 5
`
`
` APPENDIX B:
`REMS SUPPORTING DOCUMENT TEMPLATE
`MEDICATION GUIDE REMS
`
`
`This REMS Supporting Document should include the following listed sections 1 through 6. Include
`in section 4 the reason that the Medication Guide proposed to be included in the REMS is necessary
`to ensure that the benefits of the drug outweigh the risks.
`
`1. Table of Contents
`
`2. Background
`
`3. Goals
`
`4. Supporting Information on Proposed REMS Elements
`
`
`a. Medication Guide
`
`
`b. Timetable for Submission of Assessments of the REMS (for products approved under an
`NDA or BLA)
`
`
`5. REMS Assessment Plan (for products approved under an NDA or BLA)
`
`6. Other Relevant Information
`
`
`
`
`
`
`
`
`
`

`

`Application
`Type/Number
`--------------------
`NDA-22255
`
`NDA-22253
`
`NDA-22254
`
`Submission
`Type/Number
`--------------------
`ORIG-1
`
`SUPPL-6
`
`SUPPL-3
`
`Submitter Name
`
`Product Name
`
`--------------------
`SCHWARZ
`BIOSCIENCES INC
`SCHWARZ
`BIOSCIENCES INC
`SCHWARZ
`BIOSCIENCES INC
`
`------------------------------------------
`VIMPAT
`
`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
`03/19/2010
`
`

`

`
`
`
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`INFORMATION REQUEST
`
`
`
`
`NDA 22-255
`
`Schwarz-Biosciences Inc.
`c/o UCB, Inc
`Attention: Susan Tegtmeyer
`1950 Lake Park Drive
`Building 2100
`Smyrna, GA 30080
`
`
`Dear Ms. Tegtmeyer:
`
`Please refer to your New Drug Application (NDA) submitted under section 505(b) of the Federal
`Food, Drug, and Cosmetic Act for lacosamide oral solution.
`
`We are reviewing the Chemistry, Manufacturing, and Controls sections of your submission and
`have the following comments and information requests. We request a prompt written response
`in order to continue our evaluation of your NDA.
`
`
`
`
` 465
`
`1. Your NDA submission includes information for to-be-marketed
` bottle fills. However, your labeling information only includes
`mL bottle fills. Confirm the bottle fills intended for marketing.
`2. Provide all available updated results for the 10 mg/mL drug product primary stability
`batches to support your proposed expiration dating period.
`3. Your proposed annual stability commitment is unclear. Your annual stability
`commitment should add the smallest and largest containers to the stability program
`annually using
` PET bottles. If you no longer intend to market the
` bottle fills, a bracketing scheme is no longer valid. In that case samples of
`
` 465 mL bottle fills using
` PET bottles should be
`added to the stability program annually. Provide a revised post-approval stability
`protocol and annual stability commitment.
`4. Revise your carton and container labels as well as Section 16.1 of the prescribing
`information to include the following in-use expiry statement – “Discard any unused
`product remaining after seven (7) weeks of first opening the bottle.” Provide a space on
`the container labels to allow documentation of when the bottle was first opened with the
`following statement – “Date Bottle Opened: _________.” Include a “Do not freeze”
`statement on the carton and container labels and in Section 16.1 of the prescribing
`information.
`5. Revise the carton and container labels to include a statement, in parentheses, of
`lacosamide content based on total volume under the expression of strength per mL.
`
`
`
`(b) (4)
`
`(b)
`(4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`NDA 22-255
`Page 2
`
`
`If you have any questions, call Don Henry, Regulatory Project Manager, at (301) 796-4227.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Ramesh Sood, Ph.D.
`Branch Chief
`Division of Pre-Marketing Assessment I
`Office of New Drug Quality Assessment
`Center for Drug Evaluation and Research
`
`
`

`

`Application
`Type/Number
`--------------------
`NDA-22255
`
`Submission
`Type/Number
`--------------------
`ORIG-1
`
`Submitter Name
`
`Product Name
`
`--------------------
`SCHWARZ
`BIOSCIENCES INC
`
`------------------------------------------
`VIMPAT
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`RAMESH K SOOD
`02/26/2010
`
`

`

`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`PUBLIC HEALTH SERVICE
`FOOD AND DRUG ADMINISTRATION
`
`TO (Office/Division): Sylvia Gantt New Drug Microbiology
`Staff OC/OO/CDER/OPS/NDMS
`
`
`DATE
`February 18, 2010
`
`
`
`
`NDA NO.
`22-255
`
`
`IND NO.
`
`
`
`REQUEST FOR CONSULTATION
`
`FROM (Name, Office/Division, and Phone Number of Requestor): Don Henry
`Project Manager, ONDQA, 301-796-4227 on behalf of
`M. Heimann/W. Wilson-Lee
`
`
`TYPE OF DOCUMENT
`DATE OF DOCUMENT
`NDA re-submission
`October 16, 2009
`
`
`CLASSIFICATION OF DRUG
`neurology
`
`
`DESIRED COMPLETION DATE
`March 12, 2010
`
`
`
` RESPONSE TO DEFICIENCY LETTER
` FINAL PRINTED LABELING
` LABELING REVISION
` ORIGINAL NEW CORRESPONDENCE
` FORMULATIVE REVIEW
` OTHER (SPECIFY BELOW):
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PRIORITY CONSIDERATION
`NAME OF DRUG
`standard
`VIMPAT (Lacosamide)
`NAME OF FIRM: Schwarz Biosciences
`
`
`
`
`
`
` NEW PROTOCOL
` PROGRESS REPORT
` NEW CORRESPONDENCE
` DRUG ADVERTISING
` ADVERSE REACTION REPORT
` MANUFACTURING CHANGE / ADDITION
` MEETING PLANNED BY
`
` PRIORITY P NDA REVIEW
` END-OF-PHASE 2 MEETING
` CONTROLLED STUDIES
` PROTOCOL REVIEW
` OTHER (SPECIFY BELOW):
`
` DISSOLUTION
` BIOAVAILABILTY STUDIES
` PHASE 4 STUDIES
`
`REASON FOR REQUEST
`I. GENERAL
` PRE-NDA MEETING
` END-OF-PHASE 2a MEETING
` END-OF-PHASE 2 MEETING
` RESUBMISSION
` SAFETY / EFFICACY
` PAPER NDA
` CONTROL SUPPLEMENT
`II. BIOMETRICS
`
`
` CHEMISTRY REVIEW
` PHARMACOLOGY
` BIOPHARMACEUTICS
` OTHER (SPECIFY BELOW):
`
`III. BIOPHARMACEUTICS
`
`
` DEFICIENCY LETTER RESPONSE
` PROTOCOL - BIOPHARMACEUTICS
` IN-VIVO WAIVER REQUEST
`
` PHASE 4 SURVEILLANCE/EPIDEMIOLOGY PROTOCOL
` DRUG USE, e.g., POPULATION EXPOSURE, ASSOCIATED DIAGNOSES
` CASE REPORTS OF SPECIFIC REACTIONS (List below)
` COMPARATIVE RISK ASSESSMENT ON GENERIC DRUG GROUP
`
` REVIEW OF MARKETING EXPERIENCE, DRUG USE AND SAFETY
` SUMMARY OF ADVERSE EXPERIENCE
` POISON RISK ANALYSIS
`
`IV. DRUG SAFETY
`
`
` CLINICAL
`
`V. SCIENTIFIC INVESTIGATIONS
`
`
`
` NONCLINICAL
`
`
`COMMENTS / SPECIAL INSTRUCTIONS: This oral solution product has been re-formulated from the original submission
`the
` has changed. A review is requested to determine the adequacy of the new
`
`
`
`
`SIGNATURE OF REQUESTOR
`{See appended electronic signature page}
`
`PRINTED NAME AND SIGNATURE OF RECEIVER
`
`
`
`METHOD OF DELIVERY (Check one)
` DFS
` EMAIL
`
` MAIL
`
` HAND
`
`
`PRINTED NAME AND SIGNATURE OF DELIVERER
`
`
`
`
`.
`
`(b)
`(4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`Application
`Type/Number
`--------------------
`NDA-22255
`
`Submission
`Type/Number
`--------------------
`ORIG-1
`
`Submitter Name
`
`Product Name
`
`--------------------
`SCHWARZ
`BIOSCIENCES INC
`
`------------------------------------------
`VIMPAT
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`DON L HENRY
`02/18/2010
`
`MARTHA R HEIMANN
`02/18/2010
`
`

`

`
`
`
`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`
`
`NDA 22-255
`
`INFORMATION REQUEST
`
`
`
`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 New Drug Application (NDA) submitted under section 505(b) of the Federal
`Food, Drug, and Cosmetic Act (FDCA) for Vimpat (lacosamide) Oral Solution.
`
`We are reviewing your submission and have the following comments and information requests. We
`request a prompt written response in order to continue our evaluation of your NDA.
`
`RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
`
`Section 505-1 of the FDCA authorizes FDA to require the submission of a Risk Evaluation and
`Mitigation Strategy (REMS) if FDA determines that such a strategy is necessary to ensure that the
`benefits of the drug outweigh the risks (section 505-1(a)).
`
`In accordance with section 505-1 of the FDCA, we have determined that a REMS is necessary for
`Vimpat (lacosamide) Oral Solution to ensure that the benefits of the drug outweigh the increased risk
`of suicidal thoughts and behavior associated with the class of antiepileptic drugs (AEDs), of which
`Vimpat (lacosamide) Oral Solution is a member.
`
`Your proposed REMS must include the following:
`
`
`Medication Guide: As one element of a REMS, FDA