CENTER FOR DRUG EVALUATION AND
`RESEARCH
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`APPLICATION NUMBER:
`022255Orig1s000
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`PROPRIETARY NAME REVIEW(S)
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`Date:
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`To:
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`Thru:
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`From:
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`Subject:
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`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
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`
`
`May 13, 2008
`
`Russell Katz, MD, Director
`Division of Neurology Products
`Bob Rappaport, MD, Director
`Division of Anesthesia, Analgesia and Rheumatology Products
`
`Kellie Taylor, PharmD, MPH, Team Leader
`Denise Toyer, PharmD, Deputy Director
`Division of Medication Errors and Technical Support
`
`Judy Park, PharmD, Safety Evaluator
`Division of Medication Errors and Technical Support
`
`Proprietary Name, Label, and Labeling Review for Vimpat
`
`Drug Name(s):
`
`Vimpat (Lacosamide) Tablets, Oral Syrup, and Injection
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`Application Type/Number: NDA 22-253, NDA 22-254, NDA 22-255,
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`
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`Applicant:
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`OSE RCM #:
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`
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`Schwarz Biosciences, Inc.
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`2007-1610
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`(b) (4)
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`CONTENTS
`EXECUTIVE SUMMARY............................................................................................................. 3
`1 BACKGROUND..................................................................................................................... 3
`1.1
`Introduction.................................................................................................................... 3
`1.2
`Product Information....................................................................................................... 3
`2 METHODS AND MATERIALS ............................................................................................ 3
`2.1
`Proprietary Name Risk Assessment............................................................................... 4
`2.2
`Label and Labeling Risk Assessment ............................................................................ 9
`3 RESULTS.............................................................................................................................. 10
`3.1
`Proprietary Name Risk Assessment............................................................................. 10
`3.2
`Labeling and Measuring Device Risk Assessment ...................................................... 11
`4 DISCUSSION ....................................................................................................................... 12
`4.1
`Proprietary Name ......................................................................................................... 12
`4.2
`Labeling and Measuring Device Risk Assessment ...................................................... 12
`5 CONCLUSIONS and recommendations............................................................................... 13
`5.1
`Comments To the Division .......................................................................................... 14
`5.2
`Comments To The Applicant....................................................................................... 14
`6 REFERENCES...................................................................................................................... 16
`APPENDICES............................................................................................................................... 18
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`EXECUTIVE SUMMARY
`The Proprietary Name Risk Assessment found that the proposed name, Vimpat, has some similarity to
`other proprietary and established drug names, but the Failure Modes and Effects Analysis (FMEA)
`findings indicate that the proposed name does not appear to be vulnerable to name confusion that could
`lead to medication errors. This finding was consistent with and supported by an independent risk
`assessment of the proprietary name submitted by the Applicant. Thus, the Division of Medication Error
`Prevention does not object to the use of the proprietary name, Vimpat, for this product.
`The results of the Label and Labeling Risk Assessment found that the presentation of information and
`design of the proposed insert labeling and measuring devices appear to be vulnerable to confusion that
`could lead to medication errors. We believe the risks we have identified can be addressed and mitigated
`prior to drug approval, and provides recommendations in Section 5.2 that aim at reducing the risk of
`medication errors.
`However; if any of the proposed product characteristics as stated in this review are altered prior to
`approval of the product, we rescind this Risk Assessment finding, and recommends that the name be
`resubmitted for review. Additionally, if the product approval is delayed beyond 90 day from the date of
`this review, the proposed name must be resubmitted for evaluation.
`
`1 BACKGROUND
`
`1.1
`INTRODUCTION
`This consult was written in response to a request from the Division of Neurology to evaluate the
`proprietary name, insert labeling, and measuring device of Vimpat for its potential to contribute to
`medication errors. The proposed proprietary name, Vimpat, was evaluated to determine if the name could
`be potentially confused with other proprietary or established drug names. A forthcoming review (OSE
`Review #2008-633) will assess the container labels and carton labeling.
`
`1.2 PRODUCT INFORMATION
`Vimpat (Lacosamide) is a new molecular entity indicated for partial-onset seizures as adjunctive therapy
`in patients aged
` years and older,
`
`The recommended dose for partial onset seizures is 100 mg per day twice
`daily initially, then increased to 200 mg per day to 400 mg per day.
`
`
`
`The dose can be increased at weekly intervals by
`increments of 100 mg per day based on clinical response and tolerability. The maximum daily dosage of
`Vimpat is
` per day. When switching from oral to intravenous dose, the initial total daily
`intravenous dosage should equal the oral total daily dosage and frequency. The parenteral formulation of
`Vimpat can be administered without further dilution or may be mixed in a compatible diluent and should
`be administered intravenously over
`. Vimpat will be available in 50 mg, 100 mg, 150
`mg, 200 mg,
` oral syrup, and 10 mg/mL solution for injection.
`. For partial seizure indication, tablets, oral
`
`syrup and injectables are indicated.
`
`2 METHODS AND MATERIALS
`This section consists of two sections which describe the methods and materials used by the Division of
`Medication Error Prevention staff conducting a proprietary name risk assessment (see 2.1 Proprietary
`Name Risk Assessment) and labeling, and/or packaging risk assessment (see 2.2 Insert Label Risk
`Assessment). The primary focus for both of the assessments is to identify and remedy potential sources
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`of medication error prior to drug approval. The Division of Medication Error Prevention defines a
`medication error as any preventable event that may cause or lead to inappropriate medication use or
`patient harm while the medication is in the control of the health care professional, patient, or consumer. 1
`
`2.1 PROPRIETARY NAME RISK ASSESSMENT
`FDA’s Proprietary Name Risk Assessment considers the potential for confusion between the proposed
`proprietary name, Vimpat, and the proprietary and established names of drug products existing in the
`marketplace and those pending IND, NDA, and ANDA products currently under review by the Agency.
`For the proprietary name, Vimpat, the Division of Medication Error Prevention staff search a standard set
`of databases and information sources to identify names with orthographic and phonetic similarity (see
`Sections 2.1.1 for detail) and held an CDER Expert Panel discussion to gather professional opinions on
`the safety of the proposed proprietary name (see 2.1.1.2). We also conduct internal CDER prescription
`analysis studies (see 2.1.2), and, when provided, external prescription analysis studies results are
`considered and incorporated into the overall risk assessment (see detail 2.1.4).
`The Safety Evaluator assigned to the Proprietary Name Risk Assessment is responsible for considering
`the collective findings, and provides an overall risk assessment of the proposed proprietary name (see
`detail 2.1.4). The overall risk assessment is based on the findings of a Failure Modes and Effects Analysis
`(FMEA) of the proprietary name, and is focused on the avoidance of medication errors. FMEA is a
`systematic tool for evaluating a process and identifying where and how it might fail. 2 FMEA is used to
`analyze whether the drug names identified with look- or sound-alike similarity to the proposed name
`could cause confusion that subsequently leads to medication errors in the clinical setting. We use the
`clinical expertise of the Medication Error Prevention staff to anticipate the conditions of the clinical
`setting that the product is likely to be used in based on the characteristics of the proposed product.
`In addition, the product characteristics provide the context for the verbal and written communication of
`the drug names and can interact with the orthographic and phonetic attributes of the names to increase the
`risk of confusion when there is overlap, or, in some instances, decrease the risk of confusion by helping to
`differentiate the products through dissimilarity. As such, the Staff consider the product characteristics
`associated with the proposed drug throughout the risk assessment, since the product characteristics of the
`proposed may provide a context for communication of the drug name and ultimately determine the use of
`the product in the usual clinical practice setting.
`Typical product characteristics considered when identifying drug names that could potentially be
`confused with the proposed drug name include, but are not limited to established name of the proposed
`product, the proposed indication, dosage form, route of administration, strength, unit of measure, dosage
`units, recommended dose, typical quantity or volume, frequency of administration, product packaging,
`storage conditions, patient population, and prescriber population. Because drug name confusion can occur
`at any point in the medication use process, we consider the potential for confusion throughout the entire
`U.S. medication use process, including drug procurement, prescribing and ordering, dispensing,
`administration, and monitoring the impact of the medication.3
`
`
`1 National Coordinating Council for Medication Error Reporting and Prevention.
`http://www.nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
`2 Institute for Healthcare Improvement (IHI). Failure Modes and Effects Analysis. Boston. IHI:2004.
`3 Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC. 2006.
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`2.1.1 Search Criteria
`The Medication Error Prevention Staff consider the spelling of the name, pronunciation of the name when
`spoken, and appearance of the name when scripted as outlined in Appendix A.
`For this review, particular consideration was given to drug names beginning with the letter ‘V’ when
`searching to identify potentially similar drug names, as 75% of the confused drug names reported by the
`USP-ISMP Medication Error Reporting Program involve pairs beginning with the same letter.45
`To identify drug names that may look similar to Vimpat, the Staff also consider the orthographic
`appearance of the name on lined and unlined orders. Specific attributes taken into consideration include
`the length of the name (6 letters), upstrokes (2, capital letter ‘V’ and lower case letter ‘t’), downstoke
`(lower case letter ‘p’), cross-strokes (lower case letter ‘t’), and dotted letters (one, lower case letter ‘i’).
`Additionally, several letters in Vimpat may be vulnerable to ambiguity when scripted, including the letter
`‘V’ may appear as ‘Y,’ ‘U,’ or ‘L”; and a lower case ‘v’ appear as a lower case ‘r,’ ‘u,’ or ‘x’. As such,
`the Staff also consider these alternate appearances when identifying drug names that may look similar to
`Vimpat.
`When searching to identify potential names that may look or sound similar to Vimpat, the Medication
`Error Prevention Staff search for names with similar number of syllables (2), and placement of vowel and
`consonant sounds. The Applicant’s intended pronunciation of the proprietary name (VIM-pat) was also
`taken into consideration.
`The Staff also consider the product characteristics associated with the proposed drug throughout the
`identification of similar drug names, since the product characteristics of the proposed drug ultimately
`determine the use of the product in the clinical practice setting For this review, the Medication Error
`Prevention Staff were provided with the following information about the proposed product: the proposed
`proprietary name (Vimpat), the established name (Lacosamide), proposed indications (partial onset
`seizures
`), strength (50 mg, 100 mg, 150 mg, 200 mg,
` oral syrup; 10 mg/mL solution for injection), dose (200 mg/day to 400 mg/day
`
`
`for partial onset seizures,
`
`), frequency of
`administration (twice a day), route (oral and intravenous) and dosage form of the product (tablet, oral
`syrup, and injection). Appendix A provides a more detailed listing of the product characteristics the
`Medication Error Prevention Staff general take into consideration.
`Lastly, the Medication Error Prevention Staff also consider the potential for the proposed name to
`inadvertently function as a source of error for reasons other than name confusion. Post-marketing
`experience has demonstrated that proprietary names (or components of the proprietary name) can be a
`source of error in a variety of ways. As such, these broader safety implications of the name are
`considered and evaluated throughout this assessment and the Medication Error Prevention Staff provide
`additional comments related to the safety of the proposed name or product based on their professional
`experience with medication errors.
`
`2.1.1.1 Database and information sources
`The proposed proprietary name, Vimpat, was provided to the Division of Medication Error Prevention
`staff to conduct a search of the internet, several standard published drug product reference texts, and FDA
`
`
`4 Institute for Safe Medication Practices. Confused Drug name List (1996-2006). Available at
`http://www.ismp.org/Tools/confuseddrugnames.pdf
`5 Kondrack, G and Dorr, B. Automatic Identification of Confusable Drug Names. Artifical Inteligence in Medicine
`(2005)
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`databases to identify existing and proposed drug names that may sound-alike or look-alike to Vimpat,
`using the criteria outlined in 2.1.1. A standard description of the databases used in the searches is
`provided in Section 7. To complement the process, the Medication Error Prevention Staff use a
`computerized method of identifying phonetic and orthographic similarity between medication names.
`The program, Phonetic and Orthographic Computer Analysis (POCA), uses complex algorithms to select
`a list of names from a database that have some similarity (phonetic, orthographic, or both) to the
`trademark being evaluated. Lastly, the Medication Error Prevention Staff review the USAN stem list to
`determine if any USAN stems are present within the proprietary name. The findings of the individual
`Safety Evaluators were then pooled and presented to the Expert Panel.
`
`2.1.1.2 CDER Expert Panel Discussion
`An Expert Panel Discussion is held by the Division of Medication Error Prevention to gather CDER
`professional opinions on the safety of the product and the proprietary name, Vimpat. Potential concerns
`regarding drug marketing and promotion related to the proposed names are also discussed. This group is
`composed of The Division of Medication Error Prevention Staff and representatives from the Division of
`Drug Marketing, Advertising, and Communications (DDMAC).
`The pooled results of the Medication Error Prevention staff were presented to the Expert Panel for
`consideration. Based on the clinical and professional experiences of the Expert Panel members, the Panel
`may recommend the addition of names, additional searches by the Safety Evaluator to supplement the
`pooled results, or general advice to consider when reviewing the proposed proprietary name.
`
`2.1.2 CDER Prescription analysis studies
`Three separate studies are conducted within the Centers of the FDA for the proposed proprietary name to
`determine the degree of confusion of Vimpat with marketed U.S. drug names (proprietary and
`established) due to similarity in visual appearance with handwritten prescriptions or verbal pronunciation
`of the drug name. The studies employ a total of 123 healthcare professionals (pharmacists, physicians,
`and nurses), and attempts to simulate the prescription ordering process. The results are used by the Safety
`Evaluator to identify any orthographic or phonetic vulnerability of the proposed name to be
`misinterpreted by healthcare practitioners.
`In order to evaluate the potential for misinterpretation of Vimpat in handwriting and verbal
`communication of the name, inpatient medication orders and outpatient prescriptions are written, each
`consisting of a combination of marketed and unapproved drug products, including the proposed name.
`These prescriptions are optically scanned and one prescription is delivered to a random sample of 123
`participating health professionals via e-mail. In addition, a verbal prescription is recorded on voice mail.
`The voice mail messages are then sent to a random sample of the participating health professionals for
`their interpretations and review. After receiving either the written or verbal prescription orders, the
`participants send their interpretations of the orders via e-mail to the Division of Medication Error
`Prevention staff.
`
`Figure 1. Vimpat Study (conducted on August 10, 2007)
`HANDWRITTEN PRESCRIPITON AND
`MEDICATION ORDER
`
`Outpatient Prescription:
`
`VERBAL
`PRESCRIPTION
`
`Vimpat 100mg #30
`Take one tablet by mouth
`twice a day
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`6
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`Inpatient Medication Order :
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`2.1.3 External Proprietary Name Risk Assessment
`For this product, the Applicant submitted two independent risk assessments of the proposed proprietary
`name conducted by
` and Drug Safety Institute. We conduct an independent analysis and
`evaluation of the data provided, and responds to the overall findings of the assessment. When the
`external proprietary name risk assessment identifies potentially confusing names that were not captured in
`the Medication Error Prevention Staff’s database searches or in the Expert Panel Discussion, these names
`are included in the Safety Evaluator’s Risk Assessment and analyzed independently by the Safety
`Evaluator to determine if the potentially confusing name could lead to medication errors in usual practice
`settings.
`After the Safety Evaluator has determined the overall risk assessment of the proposed name, the Safety
`Evaluator compares the findings of their overall risk assessment with the findings of the proprietary name
`risk assessment submitted by the Applicant. The Safety Evaluator then determines whether our risk
`assessment concurs or differs with the findings. When the proprietary name risk assessments differ, we
`provide a detailed explanation of these differences.
`
`2.1.4 Safety Evaluator Risk Assessment of the Proposed Proprietary Name
`Based on the criteria set forth in Section 2.1.1, the Safety Evaluator Risk Assessment applies their
`individual expertise gained from evaluating medication errors reported to FDA to conduct a Failure
`Modes and Effects Analysis and provide an overall risk of name confusion. Failure Mode and Effects
`Analysis (FMEA) is a systematic tool for evaluating a process and identifying where and how it might
`fail.6 When applying FMEA to assess the risk of a proposed proprietary name, we seek to evaluate the
`potential for a proposed name to be confused with another drug name as a result of the name confusion
`and cause errors to occur in the medication use system. FMEA capitalizes on the predictable and
`preventable nature of medication errors associated with drug name confusion. FMEA allows the Agency
`to identify the potential for medication errors due to look- or sound-alike drug names prior to approval,
`where actions to overcome these issues are easier and more effective then remedies available in the post-
`approval phase.
`In order to perform an FMEA of the proposed name, the Safety Evaluator must analyze the use of the
`product at all points in the medication use system. Because the proposed product is not yet marketed, the
`Safety Evaluator anticipates the use of the product in the usual practice settings by considering the clinical
`and product characteristics listed in Appendix A. The Safety Evaluator then analyzes the proposed
`proprietary name in the context of the usual practice setting and works to identify potential failure modes
`and the effects associated with the failure modes.
`In the initial stage of the Risk Assessment, the Safety Evaluator compares the proposed proprietary name
`to all of the names gathered from the above searches, expert panel evaluation, and studies, and identifies
`potential failure modes by asking: “Is the name Vimpat, convincingly similar to another drug name,
`which may cause practitioners to become confused at any point in the usual practice setting?” An
`affirmative answer indicates a failure mode and represents a potential for Vimpat to be confused with
`another proprietary or established drug name because of look- or sound-alike similarity. If the answer to
`the question is no, the Safety Evaluator is not convinced that the names posses similarity that would cause
`confusion at any point in the medication use system and the name is eliminated from further review.
`
`6 Institute for Healthcare Improvement (IHI). Failure Modes and Effects Analysis. Boston. IHI:2004.
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`In the second stage of the Risk Assessment, all potential failure modes are evaluated to determine the
`likely effect of the drug name confusion, by asking “Could the confusion of the drug names conceivably
`result in medication errors in the usual practice setting?” The answer to this question is a central
`component of the Safety Evaluator’s overall risk assessment of the proprietary name. If the Safety
`Evaluator determines through FMEA that the name similarity would ultimately not be a source of
`medication errors in the usual practice setting, the name is eliminated from further analysis. However, if
`the Safety Evaluator determines through FMEA that the name similarity could ultimately cause
`medication errors in the usual practice setting, the Safety Evaluator will then recommend that an alternate
`proprietary name be used. In rare instances, the FMEA findings may provide other risk-reduction
`strategies, such as product reformulation to avoid an overlap in strength or an alternate modifier
`designation may be recommended as a means of reducing the risk of medication errors resulting from
`drug name confusion.
`We will object to the use of proposed proprietary name when the one or more of the following conditions
`are identified in the Safety Evaluator’s Risk Assessment:
`1. DDMAC finds the proposed proprietary name misleading from a promotional perspective, and
`the review Division concurs with DDMAC’s findings. The Federal Food, Drug, and Cosmetic
`Act provides that labeling or advertising can misbrand a product if misleading representations are
`made or suggested by statement, word, design, device, or any combination thereof, whether
`through a trade name or otherwise. [21 U.S.C 321(n); see also 21 U.S.C. 352(a) & (n)].
`2. The Division of Medication Error Prevention identifies that the proposed proprietary name is
`misleading because of similarity in spelling or pronunciation to another proprietary or established
`name of a different drug or ingredient [CFR 201.10.(C)(5)].
`3. FMEA identifies potential for confusion between the proposed proprietary name and other
`proprietary or established drug names, and demonstrates that medication errors are likely to result
`from the drug name confusion under the conditions of usual clinical practice.
`4. The proposed proprietary name contains an USAN stem, particularly in a manner that is
`contradictory to the USAN Council’s definition.
`5. The Division of Medication Error Prevention Staff identify a potential source of medication error
`within the proposed proprietary name. The proprietary name may be misleading, or inadvertently
`introduce ambiguity and confusion that leads to errors. Such errors may not necessarily involve
`confusion between the proposed drug another drug product.
`In the event that we object to the use of the proposed proprietary name, based upon the potential for
`confusion with another proposed (but not yet approved) proprietary name, we will provide a contingency
`objection based on the date of approval: whichever product is awarded approval first has the right to the
`use the name, while we will recommend that the second product to reach approval seek an alternative
`name.
`If none of these conditions are met, then we will not object to the use of the proprietary name. If any of
`these conditions are met, then we will object to the use of the proprietary name. The threshold set for
`objection to the proposed proprietary name may seem low to the Applicant; however, the safety concerns
`set forth in criteria 1 through 5 are supported either by FDA Regulation or by external healthcare
`authorities, including the IOM, WHO, JCAHO, and ISMP, have examined medication errors resulting
`from look- or sound-alike drug names and called for Regulatory Authorities to address the issue prior to
`approval.
`Furthermore, we contend that the threshold set for the Proprietary Name Risk Assessment is reasonable
`because proprietary drug name confusion is a predictable and preventable source of medication error that,
`in many instances, can be identified and remedied prior to approval to avoid patient harm.
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`Additionally, post-marketing experience has demonstrated that medication errors resulting from drug
`name confusion are notoriously difficult to remedy post-approval. Educational efforts and so on are low-
`leverage strategies that have proven to have limited effectiveness at alleviating the medication errors
`involving drug name confusion. Higher-leverage strategies, such as drug name changes, have been
`undertaken in the past; but at great financial cost to the Applicant, and at the expense of the public
`welfare, not to mention the Agency’s credibility as the authority responsible for the approving the error-
`prone proprietary name. Moreover, even after Applicant’s have changed a product’s proprietary name in
`the post-approval phase, it is difficult to eradicate the original proprietary name from practitioner’s
`vocabulary, and as such, the Agency has continued to receive reports of drug name confusion long after a
`name change in some instances. Therefore, we believe that post-approval efforts at reducing name
`confusion errors should be reserved for those cases in which the potential for name confusion could not
`be predicted prior to approval (see section 4: “Discussion” for limitations of the process).
`If we object to a proposed proprietary name on the basis that drug name confusion could lead to
`medication errors, the FMEA process is used to identify strategies to reduce the risk of medication errors.
`We are likely to recommend that the Applicant select an alternative proprietary name and submit the
`alternate name to the Agency for us to review. However, in rare instances FMEA may identify plausible
`strategies that could reduce the risk of medication error of the currently proposed name, and so we may be
`able to provide the Applicant with recommendations that reduce or eliminate the potential for error would
`render the proposed name acceptable.
`
`2.2 LABEL AND LABELING RISK ASSESSMENT
`The label and labeling of a drug product are the primary means by which practitioners and patients
`(depending on configuration) interact with the pharmaceutical product. The container labels and carton
`labeling communicate critical information including proprietary and established name, strength, form,
`container quantity, expiration, and so on. The insert labeling is intended to communicate to practitioners
`all information relevant to the approved uses of the drug, including the correct dosing and administration.
`Given the critical role that the label and labeling has in the safe use of drug products, it is not surprising
`that 33 percent of medication errors reported to the USP-ISMP Medication Error Reporting Program may
`be attributed to the packaging and labeling of drug products, including 30 percent of fatal errors.7
`Because our staff analyze reported misuse of drugs, our staff are able to use this experience to identify
`potential errors with all medication similarly packaged, labeled or prescribed. We use FMEA and the
`principles of human factors to identify potential sources of error with the proposed product labels and
`insert labeling, and provided recommendations that aim at reducing the risk of medication errors.
`For this product the Applicant submitted on September 28, 2007 the following labeling and measuring
`device for our review (see Appendix E for images):
`• Measuring devices:
`
`• Prescribing Information (no image)
`• Patient Information (no image)
`• Sample measuring devices (no image)
`
`A forthcoming review (OSE Review #2008-633) will assess the container labels and carton labeling for
`Vimpat tablets, oral syrup and injectable.
`
`
`7 Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC. 2006.
`p275.
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`3 RESULTS
`
`3.1 PROPRIETARY NAME RISK ASSESSMENT
`
`3.1.1 Data base and information sources
`We conducted a search of the internet, several standard published databases and information sources (see
`Section 7 References) for existing drug names which sound-alike or look-alike to Vimpat to a degree
`where potential confusion between drug names could occur and result in medication errors in the usual
`clinical practice settings. In total, seven names were identified as having some similarity to the name
`Vimpat.
`Four of the seven names were thought to look like Vimpat, which include: Vimar, Campath, Simplet, and
`Semprex-D. Fempatch was thought to sound like Vimpat and two names,
` and Impact, were
`thought to look and sound similar to Vimpat. No USAN stems are present within the proposed name.
`
`3.1.2 Expert panel discussion
`The Expert Panel also noted that despite orthographic similarity of the letter ‘V’ with the letters ‘Z’, ‘N’,
`‘L’, and ‘R’ in some handwriting samples, no names beginning with those letters were included in the
`pool. The Expert Panel recommended that independent searches consider the potential for confusion with
`drug names beginning with these letters.
`DDMAC had no concerns regarding the proposed name from a promotional perspective, and did not offer
`any additional comments relating to the proposed name.
`
`3.1.3 CDER Prescription analysis studies
`A total of 30 practitioners responded, but none of the responses overlapped with any existing or proposed
`drug names. About 60% of the participants (n=18) interpreted the name correctly as “Vimpat,” with
`correct interpretation occurring more frequently in the written studies. The remainder of the responses
`misinterpreted the drug name. Four respondents in the verbal prescription study each misinterpreted
`Vimpat as Zymtec, Zimpack, Zynpak, and Zin Pac. In the written prescription studies, the letter ‘a’ was
`misinterpreted as an ‘i’ by another respondent. The ending ‘-at’ was misinterpreted as ‘-art’ by five
`respondents and ‘-ert’ by one respondent. See Appendix B for the complete listing of interpretations from
`the verbal and written prescription studies.
`
`3.1.4 External Name studies
` study
`In the two proposed name risk assessments submitted by the Applicant, the
`identified and evaluated a total of 8 drug names thought to have some potential for confusion wi