CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`208194Orig1s000
`
`PROPRIETARY NAME REVIEW(S)
`
`
`
`
`
`
`
`
`

`

`PROPRIETARY NAME REVIEW
`Division of Medication Error Prevention and Analysis (DMEPA)
`Office of Medication Error Prevention and Risk Management (OMEPRM)
`Office of Surveillance and Epidemiology (OSE)
`Center for Drug Evaluation and Research (CDER)
`
`*** This document contains proprietary information that cannot be released to the
`public***
`
`Date of This Review:
`Application Type and
`Number:
`Product Name and Strength:
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Team Leader:
`
`June 15, 2015
`NDA 208194
`
`Bendeka (bendamustine) 100 mg/4 mL (25 mg/mL)
`Single
`Rx
`Eagle Pharmaceuticals, Inc.
`2015-168007
`Michelle Rutledge, PharmD
`Yelena Maslov, PharmD
`
`Reference ID: 3779524
`
`

`

`1
`
`Contents
`INTRODUCTION....................................................................................................... 1
`1.1
`Regulatory History............................................................................................... 1
`1.2
`Product Information ............................................................................................. 1
`2 RESULTS.................................................................................................................... 1
`2.1 Misbranding Assessment...................................................................................... 2
`2.2
`Safety Assessment................................................................................................ 2
`3 CONCLUSIONS ......................................................................................................... 3
`3.1
`Comments to the Applicant.................................................................................. 3
`4 REFERENCES ............................................................................................................ 4
`APPENDICES .................................................................................................................... 5
`
`Reference ID: 3779524
`
`

`

`1
`
`INTRODUCTION
`
`This review evaluates the proposed proprietary name, Bendeka, from a safety and
`misbranding perspective. The sources and methods used to evaluate the proposed name
`are outlined in the reference section and Appendix A respectively. The Applicant
`submitted an external name study, conducted by
`(we) inc ( M0 for this
`product.
`
`1.1
`
`REGULATORY HISTORY
`
`(km) on
`The Applicant previously submitted the proposed proprietary name,
`February 13, 2015 for this application. The Division of Medication Error Prevention and
`Analysis (DMEPA) found the name acceptable in OSE Review #2015—49450, dated April
`2, 2015. However, on April 14, 2015, the applicant withdrew the name,
`(hm
`
`Thus, the Applicant submitted the name, Bendeka, for review on April 14, 2015.
`
`1.2
`
`PRODUCT INFORMATION
`
`The following product information is provided in the April 14, 2015 and April 20, 2015
`proprietary name submission.
`
`0
`
`Intended Pronunciation: Ben dek’ah
`
`0 Active Ingredient: bendamustine HCL
`
`o
`
`Indication of Use: Non-Hodgkins’ lymphoma (NHL) and Chronic lymphocytic
`leukemia (CLL)
`
`0 Route of Administration: Intravenous infusion
`
`o Dosage Form: Solution for infusion
`
`0
`
`Strength: 100 mg/4 mL (25 mg/mL)
`
`0 Dose and Frequency: Non-Hodgkin ’s lymphoma (NHL): 120 mg/m2
`administered IV over 10 minutes on Days 1 and 2 of a 21-day cycle, up to 8
`cycles. Chronic lymphocytic leukemia (CLL): 100 mg/m2 administered IV over
`10 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles Requires 50-mL
`infusion bag of either 0.9% Sodium Chloride Injection, USP (normal saline),
`2.5% Dextrose/0.45% Sodium Chloride Injection, USP, or 5% Dextrose Injection,
`USP.
`(um) The maximum daily dose (dose in a 24-hour period)
`is 120 mg/m2.
`
`o How Supplied: 100 mg/4 mL (25 mg/mL) multi—use vials for intravenous
`administration
`
`0
`
`Storage: Must be refrigerated at 2°C to 8°C (36°F to 46"F). 24-month shelf-life
`and 3-hour ad—mixture stability period.
`
`2 RESULTS
`
`Reference ID: 3779524
`
`

`

`The following sections provide information obtained and considered in the overall
`evaluation of the proposed proprietary name.
`
`2.1 MISBRANDING ASSESSMENT
`
`The Office of Prescription Drug Promotion (OPDP) determined that the proposed name
`would not misbrand the proposed product. DlVIEPA and the Division of Hematology
`Products (DI-IP) concurred with the findings of OPDP’s assessment of the proposed
`name.
`
`2.2
`
`SAFETY ASSESSMENT
`
`The following aspects were considered in the safety evaluation of the name.
`
`2.2.1 United States Adopted Names (USAN) Search
`
`There is no USAN stem present in the proprietary name].
`
`2.2.2 Components ofthe Proposed Proprietary Name
`
`The Applicant indicated in their submission that the proposed name, Bendeka, is derived
`from the established name. This proprietary name is comprised of a single word that does
`not contain any components (i.e. a modifier, route of administration, dosage form, etc.)
`that are misleading or can contribute to medication error.
`
`2.2.3 FDA Name Simulation Studies
`
`Seventy-six practitioners participated in DNIEPA’S prescription studies. The responses
`did not overlap with any currently marketed products nor did the responses sound or look
`similar to any currently marketed products or any products in the pipeline. Appendix B
`contains the results from the verbal and written prescription studies.
`
`2. 2.3 Comments from Other Review Disciplines at Initial Review
`
`In response to the OSE, April 29, 2015 e—mail, the Division of Hematology Products
`(DHP) did not forward any comments or concerns relating to the proposed proprietary
`name at the initial phase of the review.
`
`2.2.4 Phonetic and Orthographic Computer Analysis (POCA) Search Results
`Table 1 lists the number of names with the combined orthographic and phonetic score of
`250% retrieved from our POCA search2 organized as highly similar, moderately similar
`or low similarity for further evaluation. Table 1 also includes names identified from the
`FDA Prescription Simulation or by one
`
`Table 1. POCA Search Results
`
`Names
`
`lUSAN stem search conducted on May 20. 2015.
`
`2 POCA search conducted on April 24. 2015.
`
`Reference ID: 3779524
`
`

`

`Highly similar name pair:
`combined match percentage score ≥70%
`Moderately similar name pair:
`combined match percentage score ≥50% to ≤ 69%
`Low similarity name pair:
`combined match percentage score ≤49%
`
`5
`
`209
`
`5
`
`2.2.5 Safety Analysis of Names with Potential Orthographic, Spelling, and Phonetic
`Similarities
`Our analysis of the 219 names contained in Table 1 determined 219 names will not pose a
`risk for confusion as described in Appendices C through H.
`
`2.2.6 Communication of DMEPA’s Analysis at Midpoint of Review
`DMEPA communicated our findings to the Division of Hematology (DHP) via e-mail on
`June 2, 2015. At that time we also requested additional information or concerns that
`could inform our review. Per e-mail correspondence from the DHP on June 3, 2015, they
`stated no additional concerns with the proposed proprietary name, Bendeka.
`
`3 CONCLUSIONS
`The proposed proprietary name is acceptable.
`If you have further questions or need clarifications, please contact Kevin Wright, OSE
`project manager, at 301-796-3621.
`
`COMMENTS TO THE APPLICANT
`3.1
`We have completed our review of the proposed proprietary name, Bendeka, and have
`concluded that this name is acceptable.
`If any of the proposed product characteristics as stated in your April 14, 2015 submission
`are altered prior to approval of the marketing application, the name must be resubmitted
`for review.
`
`Reference ID: 3779524
`
`3
`
`

`

`4 REFERENCES
`
`1. USAN Stems (http://www.ama-assn.org/ama/pub/physician-resources/medical-
`science/united-states-adopted-names-council/naming-guidelines/approved-
`stems.page)
`USAN Stems List contains all the recognized USAN stems.
`
`2. Phonetic and Orthographic Computer Analysis (POCA)
`POCA is a system that FDA designed. As part of the name similarity assessment, POCA
`is used to evaluate proposed names via a phonetic and orthographic algorithm. The
`proposed proprietary name is converted into its phonemic representation before it runs
`through the phonetic algorithm. Likewise, an orthographic algorithm exists that operates
`in a similar fashion. POCA is publicly accessible.
`Drugs@FDA
`Drugs@FDA is an FDA Web site that contains most of the drug products approved in the
`United States since 1939. The majority of labels, approval letters, reviews, and other
`information are available for drug products approved from 1998 to the present.
`Drugs@FDA contains official information about FDA-approved brand name and generic
`drugs; therapeutic biological products, prescription and over-the-counter human drugs;
`and discontinued drugs (see Drugs @ FDA Glossary of Terms, available at
`http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm#ther biological).
`
`RxNorm
`
`RxNorm contains the names of prescription and many OTC drugs available in the United
`States. RxNorm includes generic and branded:
`
` Clinical drugs – pharmaceutical products given to (or taken by) a patient with
`therapeutic or diagnostic intent
` Drug packs – packs that contain multiple drugs, or drugs designed to be
`administered in a specified sequence
`
`Radiopharmaceuticals, contrast media, food, dietary supplements, and medical devices,
`such as bandages and crutches, are all out of scope for RxNorm
`(http://www.nlm.nih.gov/research/umls/rxnorm/overview.html#).
`
`Division of Medication Errors Prevention and Analysis proprietary name consultation
`requests
`This is a list of proposed and pending names that is generated by the Division of
`Medication Error Prevention and Analysis from the Access database/tracking system.
`
`Reference ID: 3779524
`
`4
`
`

`

`APPENDICES
`Appendix A
`FDA’s Proprietary Name Risk Assessment evaluates proposed proprietary names for
`misbranding and safety concerns.
`1. Misbranding Assessment: For prescription drug products, OPDP assesses the
`name for misbranding concerns. . For over-the-counter (OTC) drug products, the
`misbranding assessment of the proposed name is conducted by DNCE. OPDP or
`DNCE evaluates proposed proprietary names to determine if the name is false or
`misleading, such as by making misrepresentations with respect to safety or
`efficacy. For example, a fanciful proprietary name may misbrand a product by
`suggesting that it has some unique effectiveness or composition when it does not
`(21 CFR 201.10(c)(3)). OPDP or DNCE provides their opinion to DMEPA for
`consideration in the overall acceptability of the proposed proprietary name.
`2. Safety Assessment: The safety assessment is conducted by DMEPA, and
`includes the following:
`a. Preliminary Assessment: We consider inclusion of USAN stems or other
`characteristics that when incorporated into a proprietary name may cause or
`contribute to medication errors (i.e., dosing interval, dosage form/route of
`administration, medical or product name abbreviations, names that include or
`suggest the composition of the drug product, etc.) See prescreening checklist
`below in Table 2*. DMEPA 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. 3
`
`
`3 National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
`
`Reference ID: 3779524
`
`5
`
`

`

`*Table 2- Prescreening Checklist for Proposed Proprietary Name
`
`Answer the questions in the checklist below. Affirmative
`answers to any of these questions indicate a potential area of
`concern that should be carefully evaluated as described in this
`'dance.
`
`Y/N
`
`Is the proposed name obviously similar in spelling and pronunciation to
`other names?
`
`Proprietary names should not be similar in spelling or pronunciation to
`proprietary names, established names, or ingredients of other products.
`
`IN
`
`Are there medical and/or coined abbreviations in the ro n rieta
`
`name?
`
`Proprietary names should not incorporate medical abbreviations (e.g., QD,
`BID, or others commonly used for prescription communication) or coined
`abbreviations that have no established meanin .
`
`S Are there inert or inactive ingredients referenced in the proprietary
`name?
`
`Proprietary names should not incorporate any reference to an inert or inactive
`ingredient in a way that might create an impression that the ingredient’s value
`is greater than its true fimctional role in the formulation (21 CFR
`201 . 10(c)(4)).
`
`
`
`IN
`
`Does the we I rieta
`
`name include combinations of active in_redients?
`
`Proprietary names of fixed combination drug products should not include or
`suggest the name of one or more, but not all, of its active ingredients (see 21
`CFR 201.6 I
`
`Y/N
`
`Is there a United States Adopted Name (USAN) stem in the proprietary
`name?
`
`Proprietary names should not incorporate a USAN stem in the position that
`USAN designates for the stem.
`
`YIN
`
`Is this proprietary name used for another product that does not share at
`least one common active in_redient?
`
`Drug products that do not contain at least one common active ingredient
`should not use the same root
`.ro u.riet
`name.
`
`Y/N
`
`Is this a to u rieta
`
`name of a discontinued .roduct?
`
`Proprietary names should not use the proprietary name of a discontinued
`product if that discontinued drug product does not contain the same active
`in u edients.
`
`Reference ID: 3779524
`
`

`

`b. Phonetic and Orthographic Computer Analysis (POCA): Following the
`preliminary screening of the proposed proprietary name, DMEPA staff evaluates
`the proposed name against potentially similar names. In order to identify names
`with potential similarity to the proposed proprietary name, DMEPA enters the
`proposed proprietary name in POCA and queries the name against the following
`drug reference databases, Drugs@fda, CernerRxNorm, and names in the review
`pipeline using a 50% threshold in POCA. DMEPA reviews the combined
`orthographic and phonetic matches and group the names into one of the following
`three categories:
`• Highly similar pair: combined match percentage score ≥70%.
`• Moderately similar pair: combined match percentage score ≥50% to ≤ 69%.
`• Low similarity: combined match percentage score ≤49%.
`Using the criteria outlined in the check list (Table 3-5) that corresponds to each of the
`three categories (highly similar pair, moderately similar pair, and low similarity),
`DMEPA evaluates the name pairs to determine the acceptability or non-acceptability
`of a proposed proprietary name. The intent of these checklists is to increase the
`transparency and predictability of the safety determination of whether a proposed
`name is vulnerable to confusion from a look-alike or sound-alike perspective. Each
`bullet below corresponds to the name similarity category cross-references the
`respective table that addresses criteria that DMEPA uses to determine whether a name
`presents a safety concern from a look-alike or sound-alike perspective.
` For highly similar names, differences in product characteristics often cannot
`mitigate the risk of a medication error, including product differences such as
`strength and dose. Thus, proposed proprietary names that have a combined score
`of ≥ 70 percent are at risk for a look-alike sound-alike confusion which is an area
`of concern (See Table 3).
` Moderately similar names with overlapping or similar strengths or doses represent
`an area for concern for FDA. The dosage and strength information is often
`located in close proximity to the drug name itself on prescriptions and medication
`orders, and it can be an important factor that either increases or decreases the
`potential for confusion between similarly named drug pairs. The ability of other
`product characteristics to mitigate confusion (e.g., route, frequency, dosage form,
`etc.) may be limited when the strength or dose overlaps. We review such names
`further, to determine whether sufficient differences exist to prevent confusion.
`(See Table 4).
` Names with low similarity that have no overlap or similarity in strength and dose
`are generally acceptable (See Table 5) unless there are data to suggest that the
`name might be vulnerable to confusion (e.g., prescription simulation study
`suggests that the name is likely to be misinterpreted as a marketed product). In
`these instances, we would reassign a low similarity name to the moderate
`similarity category and review according to the moderately similar name pair
`checklist.
`
`Reference ID: 3779524
`
`7
`
`

`

`c. FDA Prescription Simulation Studies: DMEPA staff also conducts a prescription
`simulation studies using FDA health care professionals.
`Three separate studies are conducted within the Centers of the FDA for the proposed
`proprietary name to determine the degree of confusion of the proposed proprietary
`name 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 healthcare professionals (pharmacists, physicians,
`and nurses), and attempts to simulate the prescription ordering process. The primary
`Safety Evaluator uses the results to identify orthographic or phonetic vulnerability of
`the proposed name to be misinterpreted by healthcare practitioners.
`In order to evaluate the potential for misinterpretation of the proposed proprietary
`name in handwriting and verbal communication of the name, inpatient medication
`orders and/or outpatient prescriptions are written, each consisting of a combination of
`marketed and unapproved drug products, including the proposed name. These orders
`are optically scanned and one prescription is delivered to a random sample of
`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 record their
`interpretations of the orders which are recorded electronically.
`d. Comments from Other Review Disciplines: DMEPA requests the Office of New
`Drugs (OND) and/or Office of Generic Drugs (OGD), ONDQA or OBP for their
`comments or concerns with the proposed proprietary name, ask for any clinical issues
`that may impact the DMEPA review during the initial phase of the name review.
`Additionally, when applicable, at the same time DMEPA requests concurrence/non-
`concurrence with OPDP’s decision on the name. The primary Safety Evaluator
`addresses any comments or concerns in the safety evaluator’s assessment.
`The OND/OGD Regulatory Division is contacted a second time following our
`analysis of the proposed proprietary name. At this point, DMEPA conveys their
`decision to accept or reject the name. The OND or OGD Regulatory Division is
`requested to provide any further information that might inform DMEPA’s final
`decision on the proposed name.
`Additionally, other review disciplines opinions such as ONDQA or OBP may be
`considered depending on the proposed proprietary name.
`When provided, DMEPA considers external proprietary name studies conducted by or for
`the Applicant/Sponsor and incorporates the findings of these studies into the overall risk
`assessment.
`The DMEPA primary reviewer assigned to evaluate the proposed proprietary name is
`responsible for considering the collective findings, and provides an overall risk
`assessment of the proposed proprietary name.
`
`Reference ID: 3779524
`
`8
`
`

`

`Table 3. Highly Similar Name Pair Checklist (i.e., combined Orthographic and
`Phonetic score is Z 70% .
`
`Answer the questions in the checklist below. Afiirmative answers to some of these
`questions suggest that the pattern of orthographic or phonetic differences in the
`names may render the names less likely to confusion, provided that the pair do not
`share a common strength or dose.
`
`Orthographic Checklist
`
`Phonetic Checklist
`
`pronounced differently?
`
`Considering variations in
`scripting of some letters (such
`as : andj), is there a different
`number or placement of
`upstroke/downstroke letters
`present in the names?
`
`Do the names have
`
`different number of
`
`syllables?
`
`Do the names have
`
`different syllabic stresses?
`
`Do the syllables have
`different phonologic
`processes, such vowel
`reduction, assimilation, or
`deletion?
`
`Across a range of dialects,
`are the names consistently
`
`Do the names begin with
`different first letters?
`
`Note that even when names begin
`with diflerentfirst letters, certain
`letteis may be confilsed with each
`other when scripted.
`
`Are the lengths of the names
`dissimilar" when scripted?
`
`*FDA considers the length ofnames
`dilfirent ifthe names difier by two or
`more letters.
`
`Is there different number or
`
`placement of cross-stroke or
`dotted letters present in the
`names?
`
`Do the infixes of the name
`
`appear dissimilar when
`scripted?
`
`Do the suffixes of the names
`
`appear dissimilar when
`scripted?
`
`Reference ID: 3779524
`
`

`

`Table 4: Moderately Similar Name Pair Checklist (i.e., combined score is ≥50% to
`≤69%).
`Step 1 Review the DOSAGE AND ADMINISTRATION and HOW
`SUPPLIED/STORAGE AND HANDLING sections of the prescribing
`information (or for OTC drugs refer to the Drug Facts label) to determine if
`strengths and doses of the name pair overlap or are very similar. Different
`strengths and doses for products whose names are moderately similar may
`decrease the risk of confusion between the moderately similar name pairs. Name
`pairs that have overlapping or similar strengths or doses have a higher potential
`for confusion and should be evaluated further (see Step 2). Because the strength
`or dose could be used to express an order or prescription for a particular drug
`product, overlap in one or both of these components would be reason for further
`evaluation.
`
`For single strength products, also consider circumstances where the strength may
`not be expressed.
`For any i.e. drug products comprised of more than one active ingredient,
`consider whether the strength or dose may be expressed using only one of the
`components.
`
`To determine whether the strengths or doses are similar to your proposed
`product, consider the following list of factors that may increase confusion:
`
`o Alternative expressions of dose: 5 mL may be listed in the
`prescribing information, but the dose may be expressed in metric
`weight (e.g., 500 mg) or in non-metric units (e.g., 1 tsp, 1
`tablet/capsule). Similarly, a strength or dose of 1000 mg may be
`expressed, in practice, as 1 g, or vice versa.
`
`o
`
`o
`
`Trailing or deleting zeros: 10 mg is similar in appearance to 100 mg
`which may potentiate confusion between a name pair with moderate
`similarity.
`
`Similar sounding doses: 15 mg is similar in sound to 50 mg
`
`Step 2 Answer the questions in the checklist below. Affirmative answers to some of
`these questions suggest that the pattern of orthographic or phonetic differences in
`the names may reduce the likelihood of confusion for moderately similar names
`with overlapping or similar strengths or doses.
`
`Reference ID: 3779524
`
`10
`
`

`

`Orthographic Checklist (Y/N to each
`question)
` Do the names begin with
`different first letters?
`
`Phonetic Checklist (Y/N to each
`question)
` Do the names have different
`number of syllables?
`
` Do the names have different
`syllabic stresses?
`
` Do the syllables have different
`phonologic processes, such
`vowel reduction, assimilation,
`or deletion?
`
` Across a range of dialects, are
`the names consistently
`pronounced differently?
`
`Note that even when names begin
`with different first letters, certain
`letters may be confused with each
`other when scripted.
`
` Are the lengths of the names
`dissimilar* when scripted?
`
`*FDA considers the length of names
`different if the names differ by two
`or more letters.
`
` Considering variations in
`scripting of some letters (such
`as z and f), is there a different
`number or placement of
`upstroke/downstroke letters
`present in the names?
`
`
`
`Is there different number or
`placement of cross-stroke or
`dotted letters present in the
`names?
`
` Do the infixes of the name
`appear dissimilar when
`scripted?
`
` Do the suffixes of the names
`appear dissimilar when
`scripted?
`
`Reference ID: 3779524
`
`11
`
`

`

`Table 5: Low Similari Name Pair Checklist
`
`i.e., combined score is 549% .
`
`In most circumstances, these names are viewed as sufficiently different to minimize
`confusion. Exceptions to this would occur in circumstances where, for example, there
`are data that suggest a name with low similarity is nonetheless misinterpreted as a
`marketed product name in a prescription simulation study. In such instances, FDA
`would reassign a low similarity name to the moderate similarity category and review
`
`according to the moderately similar name pair checklist.
`
`Appendix B: Prescription Simulation Samples and Results
`
`Figure 1. Bendeka Study (Conducted on Mar 4: 201.j]
`
`Handwritten Re u uisition Medication Order
`
`Verbal Prescri n tion
`
`Medication Order:
`
`Bendeka
`
`,
`
`73>me
`
`ado ,
`
`Bring to clinic
`
`#4
`
`FDA Prescription Simulation Responses (Aggregate 1 Rx Studies Report}
`
`
`
`246 People Received Study
`
`76 People Responded
`
`Study Name: Bendeka
`
`Total
`
`29
`
`22
`
`25
`
`TOTAL
`
`INTERPRETATION
`
`OI'TPATIENT
`
`VOICE
`
`INPATIENT
`
`Reference ID: 3779524
`
`12
`
`

`

`
`
`BEDBECA
`
`BEDECKA
`
`BEDEKA
`
`BENDEBA
`
`BENDECA
`
`BENDECCA
`
`BENDECKA
`
`BENDEKA
`
`BENDIBA
`
`BENDIKA
`
`BENIDIBA
`
`BENTECA
`
`BERDEKA
`
`BINDEBA
`
`0
`
`0
`
`0
`
`2
`
`0
`
`0
`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`
`23
`
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`
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`
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`
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`
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`
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`
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`
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`
`
`
`
`
`
`
`1 0 0BINDIKA 1
`
`
`
`Reference ID: 3779524
`
`13
`
`

`

`Appendix C: Highly Similar Names (e.g., combined POCA score is 270%)
`
`Proposed name: Bendeka
`
`Established name:
`
`POCA
`
`Score (%)
`
`Orthographic and/or phonetic differences in the
`names sufficient to prevent confusion
`
`
`
`Bendamustine
`
`Dosage form: Intravenous
`Infusion
`
`Strength(s): 100 mg/4 mL (25
`mg/mL)
`
`Usual Dose: Non-Hodgkin’s
`lymphoma (NHL): 120 mg/m2
`administered IV over 10
`
`minutes on Days 1 and 2 of a
`21-day cycle, up to 8 cycles.
`Chronic lymphocytic
`leukemia (CLL): 100 mg/m2
`administered IV over 10
`
`minutes on Days 1 and 2 of a
`28-day cycle, up to 6 cycles
`Requires 50-mL infusion bag
`of either 0.9% Sodium
`
`Chloride Injection, USP
`(normal saline), 2.5%
`Dextrose/0.45% Sodium
`
`Chloride Injection, USP, or
`5% Dextrose Injection, USP.
`(M) The
`
`maximum daily dose (dose in
`a 24-hour period) is 120
`mg/m2.
`
`BENDEKA***
`
`BENDOPA
`
`(Phonetic Score: 86)
`
`(Orthographic Score: 75)
`
`BENTEX
`
`(Phonetic Score: 76)
`
`
`
`Other prevention of failure mode expected to
`minimize the risk of confusion between these two
`names.
`
`Sub‘ect of this review
`
`The suffixes of this name pair have sufficient
`orthographic differences: ‘eka’ vs ‘opa’.
`
`The third syllable of this name pair sound different.
`
`This product is Withdrawn FR effective 6/25/1993.
`
`There is a cross stroke in the infix of Bentex versus the
`
`non—cross stroke in the infix of Bendeka. The extra last
`
`letter (‘a’) at the end of Bendeka has sufficient
`orthographic differences.
`
`The Bendeka name contains an extra syllable.
`
`The third (‘n’ versus ‘d”) and fourth letters (‘d’ versus
`
`Reference ID: 3779524
`
`l4
`
`

`

`
`
`(Orthographic Score: 73)
`
`‘e’) of this name pair have sufficient orthographic
`differences.
`
` This is an OTC anticavi
`
`BINACA
`(Phonetic Score' 71)
`(Orthographic Score: 70)
`
`The third syllables of this name pair sound different.
`
`No generic equivalents available.
`
`The infixes and suffixes of this name pair have
`sufficient orthographic differences.
`The second syllables of this name pair sound different.
`toothuaste, not a dru .
`
`Appendix D: Moderately Similar Names (e.g., combined POCA score is 250% to 369%)
`with no overlap or numerical similarity in Strength and/or Dose
`
`BENZAC AC
`
`(Phonetic Score: 76)
`
`BENZAC W
`
`(Phonetic Score: 82)
`
`(Orthographic Score: 71)
`
`Phonetic Score: 79
`
`
`
`BENICAR
`n BELBUCA*** _
`BENZEPRo _
`PANDEX
`
`Phonetic Score: 73
`_ BENTASIL
`Ill BENZEFOAM
`M-END PE
`
`Phonetic Score: 70
`
`s BENZAGEL
`
`BENEMID
`
`58
`
`BENOJECT-so
`
`Reference ID: 3779524
`
`15
`
`

`

`BIDEX
`15.
`16. M-END WC
`17.
`BENZO-JEL
`18.
`BETAGAN
`19.
`BONIVA
`20.
`BRONTEX
`***
`21.
`BEEPEN-VK
`22.
`BENZ-ALL
`23.
`ENDODAN
`24.
`PHENDIET
`25.
`PHENDIET 105
`26.
`BENSAL
`27.
`BENZODENT
`28.
`FERNDEX
`29.
`BANZEL
`30.
`BENZIQ WASH
`31.
`BIDNASE
`32.
`ENDOXAN
`33.
`34. MANDELAY
`35.
`TYZEKA
`36.
`BANFLEX
`37.
`BENZOIN
`38.
`BALNETAR
`39.
`BELEODAQ
`40.
`BENSAL HP
`41.
`BENZIQ LS
`42.
`BETANATE
`43.
`BICITRA
`44.
`ENDRATE
`45.
`TANDEM
`
`56
`56
`55
`55
`55
`55
`54
`54
`54
`54
`54
`54
`53
`53
`53
`52
`52
`52
`52
`52
`52
`51
`51
`50
`50
`50
`50
`50
`50
`50
`50
`
`Reference ID: 3779524
`
`16
`
`(b) (4)
`
`

`

`46.
`
`Pentasa
`(Phonetic Score: 76)
`47. Med-JEC-40
`(Phonetic Score: 71)
`GENTAK
`(Phonetic Score: 70)
`
`48.
`
`64
`
`52
`
`60
`
`Reference ID: 3779524
`
`17
`
`

`

`Appendix E: Moderately Similar Names (e.g., combined POCA score is 250% to 369%)
`with overlap or munerical similarity in Strength and/or Dose
`
`POCA
`Score (%)
`
`Prevention of Failure Mode
`
`In the conditions outlined below, the following
`combination of factors, are expected to minimize the
`risk of confusion between these two names
`
`The suffixes of this name pair have sufficient
`orthographic differences.
`The Bendeka name contains an extra syllable.
`
`The extra last letter (‘a’) at the end of Bendeka has
`sufficient orthographic differences. In addition, there
`are differences in dosing between these two products
`(Days 1 and 2 of either a 21 or 28 day cycle for Bendeka
`versus 1 tablet every 12 hours for Pendex).
`
`The Bendeka name contains an extra s llable.
`
`Proposed name: Bendeka
`Established name:
`Bendamustme
`Dosage form: Intravenous
`Infusion
`
`Strength(s): 100 mg/4 mL (25
`mg/mL)
`
`Usual Dose: Non—Hodgkin’s
`lymphoma (NHL): 120 mg/m2
`administered IV over 10
`
`minutes on Days 1 and 2 of a
`21-day cycle, up to 8 cycles.
`Chronic lymphocytic
`leukemia (CLL): 100 mg/m2
`administered IV over 10
`
`minutes on Days 1 and 2 of a
`28-day cycle, up to 6 cycles
`Requires 50—mL infusion bag
`of either 0.9% Sodium
`
`Chloride Injection, USP
`(normal saline), 2.5%
`Dextrose/0.45% Sodium
`
`Chloride Injection, USP, or
`5% Dextrose Injection, USP.
`M4) The
`
`maximum daily dose (dose in
`a 24-hour period) is 120
`
`BENZAC
`(Phonetic Score: 78)
`
`PENDEX
`(Phonetic Score: 76)
`
`
`
`.
`
`BENZACOT
`
`The infixes and suffixes of this name pair have
`
`Reference ID: 3779524
`
`18
`
`

`

`(Phonetic Score: 71)
`
`BENLYSTA
`
`***
`
`DENDRID
`
`ENDEP
`
`10 BENZAGEL
`
`BENZAGEL
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`10.
`
`CANDEX
`
`11.
`
`BENZACLIN
`
`12.
`
`BEDSIDE-CARE
`
`13.
`
`BELKIMA
`
`14.
`
`BENEFIX
`
`sufficient orthographic differences.
`The second syllables of this name pair sound different.
`The infixes of this name pair have sufficient
`orthographic differences.
`The second syllables of this name pair sound different
`The suffixes of this name pair have sufficient
`orthographic differences.
`The Bendeka name contains an extra syllable.
`The suffixes of this name pair have sufficient
`orthographic differences.
`The Bendeka name contains an extra syllable.
`The suffixes of this name pair have sufficient
`orthographic differences.
`The Bendeka name contains an extra syllable.
`The infixes of this name pair have sufficient
`orthographic differences.
`The 10 Benzagel name contains an extra syllable.
`The infixes and suffixes of this name pair have
`sufficient orthographic differences
`The second and third syllables of this name pair sound
`different.
`The suffixes of this name pair have sufficient
`orthographic differences.
`The Bendeka name contains an extra syllable.
`The infixes of this name pair have sufficient
`orthographic differences.
`The second and third syllables of this name pair sound
`different.
`The infixes and suffixes of this name pair have
`sufficient orthographic differences
`The second syllables of this name pair sound different.
`The prefixes of this name pair have sufficient
`orthographic differences.
`The second syllables of this name pair sound different.
`The infixes of this name pair have sufficient
`orthographic differences
`
`61
`
`60
`
`59
`
`58
`
`56
`
`56
`
`56
`
`55
`
`52
`
`52
`
`52
`
`Reference ID: 3779524
`
`19
`
`(b) (4)
`
`

`

`
`
`The second and third syllables of this name pair sound
`different.
`
`NANIENDA
`
`52
`
`The infixes of this name pair have sufficient
`orthographic differences.
`
`The first and second syllables of this name pair sound
`different.
`
`STENDRA
`
`17.
`
`ENDACOF C
`
`1
`
`50
`
`The infixes of this name pair have sufficient
`orthographic differences.
`
`The Bendeka name contains an extra syllable.
`
`The suffixes