CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`
`
`
`APPLICATION NUMBER:
`
`
`209472Orig1s000
`
`
`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:
`April 28, 2017
`Application Type and Number: NDA 209472
`Product Name and Strength:
`Pemfexy (pemetrexed) Injection
`25 mg/mL
`500 mg/ 20 mL
`Single Ingredient
`Rx
`Eagle Pharmaceuticals Inc.
`2017-13241140
`Janine Stewart, PharmD
`Danielle Harris, PharmD, BCPS
`
`Total Product Strength:
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Acting Deputy
`Director:
`
`Reference ID: 4091086
`
`

`

`1
`
`Contents
`INTRODUCTION........................................................................................................1
`
`1.1 Regulatory History................................................................................................1
`
`1.2
`Product Information ..............................................................................................1
`
`2 RESULTS.....................................................................................................................1
`
`2.1 Misbranding Assessment ......................................................................................1
`
`2.2
`Safety Assessment.................................................................................................2
`
`3 CONCLUSIONS ..........................................................................................................5
`
`3.1 Comments to the Applicant...................................................................................5
`
`4 REFERENCES.............................................................................................................7
`
`APPENDICES .....................................................................................................................7
`
`
`
`
`Reference ID: 4091086
`
`

`

`INTRODUCTION
`1
`
` This review evaluates the proposed proprietary name, Pemfexy, 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
`, for this product.
`
`1.1 PRODUCT INFORMATION
`The following product information is provided in the February 16, 2017 proprietary name
`submission.
`
`Intended Pronunciation: Pem-FECKS-ee
`
` Active Ingredient: pemetrexed
`Indication of Use:
`
` Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer:
`o Initial treatment in combination with cisplatin.
`o Maintenance treatment of patients whose disease has not progressed after four
`cycles of platinum-based first-line chemotherapy.
`o After prior chemotherapy as a single-agent.
` Mesothelioma:
`o
`in combination with cisplatin.
`
` Route of Administration: Intravenous
` Dosage Form: Injection
` Strength: 25 mg/mL
` Dose and Frequency: 500 mg/m2 day 1 of each 21-day cycle (10-minute infusion).
`
`
`
`
` How Supplied: vials containing 500 mg/ 20 mL of pemetrexed packaged in individual
`cartons
` Storage: Store at 2°C to 8°C (36°F to 46°F); allow to reach room temperature prior to
`dose administration
` Container and Closure Systems: glass vials
`
`
`2 RESULTS
`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. DMEPA and the Division Oncology Products 2 (DOP2)
`concurred with the findings of OPDP’s assessment of the proposed name.
`
`Reference ID: 4091086
`
`1
`
`(b) (4)
`
`(b) (4)
`
`

`

`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 namea.
`
`
`2.2.2 Components of the Proposed Proprietary Name
`The Applicant indicated in their submission that the proposed name, Pemfexy, incorporates part
`
`of the chemical name for pemetrexed injection, pemetrexed diacid or pemetrexed free acid; the
`“pem-“stem portion. 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 Comments from Other Review Disciplines at Initial Review
`In response to the OSE, March 1, 2017 e-mail, the Division of Oncology Products 2 (DOP2) did
`not forward any comments or concerns relating to the proposed proprietary name at the initial
`phase of the review.
`
`2.2.4 FDA Name Simulation Studies
`
`Eighty-three practitioners participated in DMEPA’s prescription simulation 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.
`
`2.2.5 Phonetic and Orthographic Computer Analysis (POCA) Search Results
`Our POCA searchb identified 91 names with a combined phonetic and orthographic score of
`≥55% or an individual phonetic or orthographic score ≥70. These names are included in Table 1
`
`below.
`
`2.2.6 Names Retrieved for Review Organized by Name Pair Similarity
`Table 1 lists the number of names retrieved from our POCA search and the
`external study. These name pairs are organized as highly similar, moderately similar, or low
`similarity for further evaluation.
`
`
`
`a USAN stem search conducted on March 1, 2017.
`b POCA search conducted on April 5, 2017 in version 4.0.
`
`Reference ID: 4091086
`
`2
`
`(b) (4)
`
`

`

`Table 1. Similarity Category
`
`Highly similar name pair:
`combined match percentage score ≥70%
`Moderately similar name pair:
`combined match percentage score ≥55% to ≤ 69%
`Low similarity name pair:
`combined match percentage score ≤54%
`
`Number of
`Names
`3
`
`88
`
`19
`
`2.2.7 Safety Analysis of Names with Potential Orthographic, Spelling, and Phonetic
`
`Similarities
`
`
`Our analysis of the 110 names contained in Table 1 determined 110 names would not pose a risk
`
`for confusion as described in Appendices C through H.
`
`2.2.8 Communication of DMEPA’s Analysis at Midpoint of Review
`
`DMEPA communicated our findings to the Division of Oncology Products 2 (DOP2) via e-mail
`on April 23, 2017. At that time, we also requested additional information or concerns that could
`inform our review. Per e-mail correspondence from DOP2 on April 28, 2017, they stated no
`additional concerns with the proposed proprietary name, Pemfexy.
`
`3 CONCLUSIONS
`The proposed proprietary name is acceptable.
`If you have any questions or need clarifications, please contact Latonia Ford, OSE project
`manager, at 301-796-4910.
`
`COMMENTS TO THE APPLICANT
`3.1
`We have completed our review of the proposed proprietary name, Pemfexy, and have concluded
`that this name is acceptable.
`If any of the proposed product characteristics as stated in your February 16, 2017 submission are
`altered prior to approval of the marketing application, the name must be resubmitted for review.
`
`Reference ID: 4091086
`
`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: 4091086
`
`4
`
`

`

`3. Electronic Drug Registration and Listing System (eDRLS) database
`The electronic Drug Registration and Listing System (eDRLS) was established to supports the
`FDA’s Center for Drug Evaluation and Research (CDER) goal to establish a common Structured
`Product Labeling (SPL) repository for all facilities that manufacture regulated drugs. The system
`is a reliable, up-to-date inventory of FDA-regulated, drugs and establishments that produce drugs
`and their associated information.
`
`Reference ID: 4091086
`
`5
`
`

`

`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 DNDP. OPDP or DNDP 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 DNDP
`
`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. c
`
`c National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
`
`Reference ID: 4091086
`
`6
`
`

`

`*Table 2- Prescreening Checklist for Proposed Proprietary Name
`
`Y/N
`
`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 guidance.
`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.
`Y/N 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 functional role in the formulation (21 CFR 201.10(c)(4)).
`Y/N Does the proprietary name include combinations of active ingredients?
`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(b)).
`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.
`Is this proprietary name used for another product that does not share at least
`one common active ingredient?
`Drug products that do not contain at least one common active ingredient should not
`use the same (root) proprietary name.
`Is this a proprietary name of a discontinued product?
`Proprietary names should not use the proprietary name of a discontinued product if
`that discontinued drug product does not contain the same active ingredients.
`
`Y/N
`
`Y/N
`
`Y/N
`
`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 55% 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 ≥55% to ≤ 69%.
`
`• Low similarity: combined match percentage score ≤54%.
`
`Reference ID: 4091086
`
`7
`
`

`

` 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 are further evaluated to identify the presence of attributes that
`are known to cause name confusion.
`
` Name attributes: We note that the beginning of the drug name plays a
`significant role in contributing to confusion. Additionally, drug name pairs
`
`that start with the same first letter and contain a shared letter string of at
`
`least 3 letters in both names are major contributing factor in the confusion
`of drug namesd. We evaluate all moderately similar names retrieved from
`
`POCA to identify the above attributes. These names are further evaluated
`
`to identify overlapping or similar strengths or doses.
` Product attributes: Moderately similar names of products that have
`overlapping or similar strengths or doses represent an area for concern for
`FDA. The dose and strength information is often located in close
`
`proximity to the drug name itself on prescriptions and medication orders,
`and the information 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) may be limited when the strength or dose
`overlaps. DMEPA reviews 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.
`
`
`d Shah, M, Merchant, L, Characteristics That May Help in the Identification of Potentially Confusing Proprietary
`Drug Names. Therapeutic Innovation & Regulatory Science, September 2016
`
`
`Reference ID: 4091086
`
`8
`
`

`

`
`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: 4091086
`
`9
`
`

`

`Table 3. Highly Similar Name Pair Checklist (i.e., combined Orthographic and Phonetic
`
`
`
`score is ≥ 70%).
`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 render the names less likely to confusion, provided that the pair does not share a
`
`common strength or dose.
`
`
`
`Orthographic Checklist
` Y/N Do the names begin with different
`first letters?
`Note that even when names begin
`with different first letters, certain
`
`
`letters may be confused with each
`other when scripted.
`Y/N 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.
`Y/N 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?
`
`Y/N
`
`Phonetic Checklist
`Y/N Do the names have different
`number of syllables?
`
`Y/N Do the names have different
`syllabic stresses?
`
` Y/N Do the syllables have different
`
`
` phonologic processes, such
`vowel reduction, assimilation,
`or deletion?
`
`Y/N Across a range of dialects, are
`the names consistently
`pronounced differently?
`
`Y/N Do the infixes of the name appear
`dissimilar when scripted?
`Y/N Do the suffixes of the names appear
`dissimilar when scripted?
`
`Reference ID: 4091086
`
`10
`
`

`

`
` Table 4: Moderately Similar Name Pair Checklist (i.e., combined score is ≥55% 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:
` 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.
`
` 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: 4091086
`
`11
`
`

`

`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?
`
`Orthographic Checklist (Y/N to each
`question)
` Do the names begin with different
`
`first letters?
`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?
`
`
`
`Table 5: Low Similarity Name Pair Checklist (i.e., combined score is ≤54%).
` Names with low similarity are generally acceptable 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: 4091086
`
`12
`
`

`

`Appendix B: Prescription Simulation Samples and Results
`
`Figure 1. Pemfexy Study (Conducted on March 20, 2017)
`
`Handwritten Medication Order/Prescription
`
`Medication Order:
`
`Outpatient Prescription:
`
`Verbal
`Prescription
`Pemfexy
`Bring to clinic
`Dispense #2
`
`Reference ID: 4091086
`
`13
`
`(b) (4)
`
`

`

`FDA Prescription Simulation Responses (Aggregate 1 Rx Studies Report)
`
`299 People Received
`Study
`83 People Responded
`
`MG
`
`Study Name: Pemfexy
`23
`26
`34
`Total
`INTERPRETATION OUTPATIENT VOICE INPATIENT TOTAL
`PEMBEXY
`1
`0
`1
`2
`PEMFEXI
`0
`2
`0
`2
`PEMFEXIE
`0
`1
`0
`1
`PEMFEXRY
`2
`0
`0
`2
`PEMFEXY
`24
`4
`18
`46
`PEMFEXY
`0
`0
`1
`1
`PEMFLEXY
`2
`1
`2
`5
`PEMSEXI
`0
`1
`0
`1
`PENFEXI
`0
`1
`0
`1
`PENFEXY
`4
`1
`0
`5
`PENFLEXY
`1
`0
`0
`1
`PENSEXY
`0
`1
`0
`1
`PERFEXY
`0
`0
`1
`1
`TEMFEXE
`0
`1
`0
`1
`TEMFEXEE
`0
`1
`0
`1
`TEMFEXI
`0
`6
`0
`6
`TEMFEXY
`0
`3
`0
`3
`TEMPHEXY
`0
`1
`0
`1
`TENFEXY
`0
`1
`0
`1
`TENSUKSI
`0
`1
`0
`1
`
`Reference ID: 4091086
`
`14
`
`(b) (4)
`
`

`

`Appendix C: Highly Similar Names (e.g., combined POCA score is ≥70%)
`
`No. Proposed name: Pemfexy
`Established name:
`pemetrexed
`Dosage form: Injection
`Strength(s): 500 mg/20 mL
`Usual Dose: 500 mg/m2 day 1
`
`of each 21-day cycle.
`
`
`
`
`
`1.
`2.
`3.
`
`.
`
`Emflex
`Pemfexy***
`Plemex
`
`POCA
`Score
`(%)
`
`Orthographic and/or phonetic differences in the
`names sufficient to prevent confusion
`
`Other prevention of failure mode expected to
`minimize the risk of confusion between these two
`names.
`
`70
`100
`70
`
`An international product name.
`The subject of this review.
`An international product name.
`
`
`
` Appendix D: Moderately Similar Names (e.g., combined POCA score is ≥55% to ≤69%) with
`no overlap or numerical similarity in Strength and/or Dose
`No. Name
`POCA
`Score (%)
`60
`62
`59
`56
`56
`56
`68
`63
`62
`60
`58
`56
`58
`58
`
`1.
`2.
`3.
`4.
`5.
`6.
`7.
`8.
`9.
`10.
`11.
`12.
`13.
`14.
`
`Banflex
`Benefix
`Centex
`Pancof Exp
`Pediatex
`Pediatex 12
`Pendex
`Pen-G Max
`Penject
`Pentrax
`Peptimax 800
`Peranex
`Peroxyl
`Phentex La
`
`Reference ID: 4091086
`
`15
`
`(b) (4)
`
`

`

`No. Name
`
`15.
`16.
`17.
`18.
`19.
`20.
`
`Pneumovax 23
`Premphase
`Premphase 14/14
`Prenexa
`Trimpex
`Trimpex 200
`
`POCA
`Score (%)
`56
`56
`56
`62
`64
`64
`
`Appendix E: Moderately Similar Names (e.g., combined POCA score is ≥55% to ≤69%) with
`
`overlap or numerical similarity in Strength and/or Dose
`
`No. Proposed name: Pemfexy
`Established name: pemetrexed
`Dosage form: Injection
`Strength(s): 500 mg/20 mL
`Usual Dose: 500 mg/m2 day 1 of
`each 21-day cycle.
`
`
`
`
`
`Buffex
`
`Panex
`
`Panex 500
`
`Pemetrexed
`
`Pentoxil
`
`Peptimax 200
`
`Peptimax 400
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`POCA
`Score
`(%)
`
`
`
`56
`
`58
`
`58
`
`60
`
`60
`Phon 71
`58
`
`58
`
`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
`
`
`
`
`
` This name pair has sufficient orthographic and
`phonetic differences.
` This name pair has sufficient orthographic and
`phonetic differences.
` This name pair has sufficient orthographic and
`phonetic differences.
` This name pair has sufficient orthographic and
`phonetic differences.
` This name pair has sufficient orthographic and
`phonetic differences.
`
`
`
`
`
`
`
`
`
` This name pair has sufficient orthographic and
`phonetic differences.
` This name pair has sufficient orthographic and
`phonetic differences.
`
`
`
`Reference ID: 4091086
`
`16
`
`(b) (4)
`
`

`

`No. Proposed name: Pemfexy
`Established name: pemetrexed
`Dosage form: Injection
`Strength(s): 500 mg/20 mL
`Usual Dose: 500 mg/m2 day 1 of
`each 21-day cycle.
`
`
`
`
`
`8.
`
`9.
`
`Phenytex
`
`Phlemex
`
`10.
`
`Tums E-X
`
`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
`
`65
`Phon 70
`64
`Orth 71
`64
`Phon 78
`
`
`
` This name pair has sufficient orthographic and
`phonetic differences.
`
`
`
` This name pair has sufficient orthographic and
`phonetic differences.
`
`
`
` This name pair has sufficient orthographic and
`phonetic differences.
`
`Appendix F: Low Similarity Names (e.g., combined POCA score is ≤54%)
`
`
`No.
`
`Name
`
`1.
`2.
`3.
`4.
`5.
`6.
`7.
`8.
`
`Demerol
`Doribax
`Fexofenadine
`Fortaz
`Humalog
`PanOxyl
`PanOxyl 10
`PanOxyl 5
`
`Reference ID: 4091086
`
`POCA
`Score (%)
`34
`29
`30
`19
`13
`54
`54
`54
`
`17
`
`(b) (4)
`
`

`

`No.
`
`9.
`10.
`11.
`12.
`13.
`14.
`15.
`16.
`17.
`18.
`19.
`
`Name
`
`Pembrolizumab
`Pentamidine
`Pentasa
`Pentazocine
`Pentoxifylline
`Peridex
`Pramox
`Primaxin IV
`Pur-Oxy
`Raloxifene
`Relafen
`
`POCA
`Score (%)
`32
`38
`50
`37
`41
`54
`52
`38
`50
`24
`26
`
`Appendix G: Names not likely to be confused or not used in usual practice settings for the
`reasons described.
`
`No.
`
`Name
`
`POCA
`Score (%)
`60
`
`1.
`
`2.
`
`3.
`
`4.
`
`Bentex
`
`Pandex
`
`Peditex
`
`***
`
`55
`
`62
`
`64
`
`Failure preventions
`
`International product formerly marketed in the
`United Kingdom.
`The Applicant withdrew the proposed name
`
`*** on June 5, 2015. NDA 206323 approved with
`the name Tuxarin ER under OSE RCM# 2015­
`661134.
`Name identified in RxNorm database. Unable to find
`product characteristics in commonly used internal
`drug databases.
`Name identified in RxNorm database. Unable to find
`product characteristics in commonly used internal
`drug databases.
`
`Reference ID: 4091086
`
`18
`
`(b) (4)
`
`(b) (4)
`
`

`

`No.
`
`Name
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`10.
`
`11.
`
`12.
`
`Penetrex
`
`Pentoxyl
`
`Perifix
`
`Permax
`
`Polyflex
`
`Proflex
`
`***
`
`Synflex
`
`13.
`
`Temetex
`
`POCA
`Score (%)
`60
`
`65
`
`61
`
`63
`
`56
`
`58
`
`64
`
`62
`
`68
`
`Failure preventions
`
`Product Withdrawn FR Effective April 4, 2005. No
`generic equivalent available.
`Name identified in RxNorm database. Unable to find
`product characteristics in commonly used internal
`drug databases.
`Name identified in RxNorm database. Unable to find
`product characteristics in commonly used internal
`drug databases.
`Product Withdrawn Pending FR Effective April 8,
`2009. No generic equivalent available.
`Name identified in RxNorm database. Unable to find
`product characteristics in commonly used internal
`drug databases.
`International product formerly marketed in United
`Kingdom, Ireland, South Africa, and Philippines.
`Name denied under OSE RCM# 2014-26145. No
`a