CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`208341Orig1s000
`
`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:
`January 8, 2016
`Application Type and Number: NDA 208341
`Product Name and Strength:
`Epclusa
`(sofosbuvir and velpatasvir) Tablets
`400 mg/100 mg
`Multi-Ingredient Product
`Rx
`Gilead Sciences, Inc.
`2015-1886182
`Mónica Calderón, PharmD, BCPS
`Vicky Borders-Hemphill, PharmD
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Team Leader:
`
`Reference ID: 3870779
`
`

`

`1
`
`2
`
`Contents
`INTRODUCTION........................................................................................................1
`1.1
`Product Information ..............................................................................................1
`RESULTS.....................................................................................................................1
`2.1 Misbranding Assessment ......................................................................................1
`2.2
`Safety Assessment.................................................................................................1
`CONCLUSIONS..........................................................................................................1
`3.1
`Comments to the Applicant...................................................................................3
`REFERENCES.............................................................................................................4
`4
`APPENDICES .....................................................................................................................5
`
`3
`
`
`
`Reference ID: 3870779
`
`

`

`INTRODUCTION
`1
`This review evaluates the proposed proprietary name, Epclusa, 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.
`
`PRODUCT INFORMATION
`1.1
`The following product information is provided in the October 30, 2015 proprietary name
`submission.
`Intended Pronunciation: ep-KLOO-suh
`
` Active Ingredient: sofosbuvir and velpatasvir
`Indication of Use: Treatment of chronic hepatitis C infection
`
` Route of Administration: oral
` Dosage Form: tablet
` Strength: 400 mg/100 mg
` Dose and Frequency: one tablet once daily
` How Supplied: 28-count bottles
` Storage: At or below 30˚C
`
`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 of Antiviral
`Products (DAVP) 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 name1.
`
`1USAN stem search conducted on December 2, 2015.
`
`Reference ID: 3870779
`
`1
`
`(b) (4)
`
`

`

`2.2.2 Components of the Proposed Proprietary Name
`The Applicant did not provide a derivation or intended meaning for the proposed name,
`Epclusa in their submission. 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
`Sixty-five practitioners participated in DMEPA’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. Thirty-two
`participants correctly identified the name. Fifteen participants misinterpreted the letter ‘s’
`for the letter ‘r’ (n= 15 outpatient). Appendix B contains the results from the verbal and
`written prescription studies.
`
`2.2.4 Comments from Other Review Disciplines at Initial Review
`In response to the OSE, November 13, 2015 e-mail, the Division of Antiviral Products
`(DAVP) did not forward any comments or concerns relating to the proposed proprietary
`name at the initial phase of the review.
`
`2.2.5 Phonetic and Orthographic Computer Analysis (POCA) Search Results
`Table 1 lists the number of names with the combined orthographic and phonetic score of
`≥50% 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
`external name study.
`
`Table 1. POCA Search Results
`
`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%
`
`Number of
`Names
`1
`
`42
`
`7
`
`2.2.6 Safety Analysis of Names with Potential Orthographic, Spelling, and Phonetic
`Similarities
`Our analysis of the 50 names contained in Table 1 and determined none of the names will
`pose a risk for confusion as described in Appendices C through H.
`
`
`2 POCA search conducted on December 2, 2015.
`
`Reference ID: 3870779
`
`2
`
`(b) (4)
`
`

`

`2.2.7 Communication of DMEPA’s Analysis at Midpoint of Review
`DMEPA communicated our findings to the Division of Antiviral Products (DAVP) via e-
`mail on December 15, 2015. At that time we also requested additional information or
`concerns that could inform our review. Per e-mail correspondence from the DAVP on
`January 8, 2015, they stated no additional concerns with the proposed proprietary name,
`Epclusa.
`
`3 CONCLUSIONS
`The proposed proprietary name is acceptable.
`If you have any questions or need clarifications, please contact Danyal Chaudhry, OSE
`project manager, at 301-796-3813.
`
`COMMENTS TO THE APPLICANT
`3.1
`We have completed our review of the proposed proprietary name, Epclusa, and have
`concluded that this name is acceptable.
`If any of the proposed product characteristics as stated in your October 30, 2015
`submission are altered prior to approval of the marketing application, the name must be
`resubmitted for review.
`
`Reference ID: 3870779
`
`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.
`
`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: 3870779
`
`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 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. 3
`
`3 National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors.html. Last accessed 10/11/2007.
`
`Reference ID: 3870779
`
`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 guidance.
`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.
`Y/N Are there medical and/or coined abbreviations in the proprietary 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 meaning.
`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)).
`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.
`Y/N 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.
`Y/N 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.
`
`Reference ID: 3870779
`
`6
`
`

`

`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: 3870779
`
`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.
`
`Reference ID: 3870779
`
`8
`
`

`

`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.
`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.
`
`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?
`
`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?
`Y/N Is there different number or
`placement of cross-stroke or dotted
`letters present in the names?
`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: 3870779
`
`9
`
`

`

`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:
`
` 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: 3870779
`
`10
`
`

`

`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 ≤49%).
`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.
`
`Reference ID: 3870779
`
`11
`
`

`

`Appendix B: Prescription Simulation Samples and Results
`Figure 1. Epclusa Study (Conducted on November 20, 2015)
`
`Handwritten Requisition Medication Order
`Medication Order:
`
`Outpatient Prescription:
`
`Verbal Prescription
`Epclusa
`Take 1 tablet my mouth once
`daily
`#28
`
`FDA Prescription Simulation Responses (Aggregate 1 Rx Studies Report)
`242 People Received Study
`65 People Responded
`
`Study Name: Epclusa
`Total
`NTERPRETATION
`ACLUSA
`EBCLOOSA
`EBCLUSA
`ECLUSA
`EPCLIUSA
`EPCLUESA
`EPCLURA
`EPCLUSA
`EPCLUSIA
`EPCLUZA
`EPELURA
`EPELUSA
`EPIDURA
`EPILURA
`EPILUSA
`EPLUSA
`EPOLUSA
`
` 21
`INPATIENT
`0
`0
`0
`0
`1
`0
`0
`17
`0
`0
`0
`1
`0
`0
`0
`1
`1
`
`TOTAL
`1
`1
`3
`1
`1
`1
`6
`32
`1
`1
`3
`4
`1
`5
`2
`1
`1
`
` 22
`OUTPATIENT
`0
`0
`0
`0
`0
`0
`6
`2
`0
`0
`3
`3
`1
`5
`2
`0
`0
`
` 22
`VOICE
`1
`1
`3
`1
`0
`1
`0
`13
`1
`1
`0
`0
`0
`0
`0
`0
`0
`
`12
`
`Reference ID: 3870779
`
`

`

`Appendix C: Highly Similar Names (e.g., combined POCA score is ≥70%)
`
`POCA
`Score (%)
`
`Orthographic and/or phonetic differences in the
`names sufficient to prevent confusion
`
`No.
`
`Proposed name: Epclusa
`Established name:
`sofosbuvir and velpatasvir
`Dosage form: tablets
`Strength(s): 400/100 mg
`Usual Dose: One tablet once
`daily
`
`1.
`
`***
`
`72
`
`Other prevention of failure mode expected to
`minimize the risk of confusion between these two
`names.
`
`Secondary name proposed and submitted for NDA
`203100. Name withdrawn by Applicant 2/16/2012.
`Product was approved under the proprietary name
`Stribild.
`
`Appendix D: Moderately Similar Names (e.g., combined POCA score is ≥50% to ≤69%)
`with no overlap or numerical similarity in Strength and/or Dose
`
`No.
`
`2.
`3.
`4.
`5.
`6.
`7.
`8.
`9.
`10.
`11.
`12.
`13.
`
`Name
`
`IclusIG
`Hepflush
`***
`Ceta Plus
`Aplisol
`Epi-Clenz
`ESCLIM
`Pluset
`X-Seb Plus
`Enplus-HD
`Ex-Lax
`SF 5000 Plus
`
`POCA
`Score (%)
`62
`58
`54
`53
`52
`52
`52
`52
`52
`51
`50
`50
`
`***This document contains proprietary information that cannot be released to the public***
`
`Reference ID: 3870779
`
`13
`
`(b) (4)
`
`(b) (4)
`
`

`

`Appendix E: Moderately Similar Names (e.g., combined POCA score is 250% to 369%)
`with overlap or numerical similarity in Strength and/or Dose
`
`Proposed name: Epclusa
`
`Established name:
`
`sofosbuvir and velpatasvir
`
`
`
`Dosage form: tablets
`
`Strength(s): 400/100 mg
`
`Usual Dose: One tablet once
`
`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
`
`14.
`
`l 5.
`
`1 6.
`
`1 7.
`
`1 8.
`
`
`
`Ecee lus
`
`62
`
`Epiklor
`
`56
`
`
`
`The prefixes and suffixes of this name pair have
`sufiicient orthographic differences.
`
`The first, second, and third syllables of this name pair
`sound different.
`
`The infixes of this name pair have sufficient
`orthographic differences.
`
`The first and second syllables of this name pair sound
`different.
`
`N0 strength overlap between Eplcusa (400 mg/ 100 mg)
`vs.
`(hm)
`
`).
`
`Single strength GSpclusa) vs. multiple strength
`(m4) requiring a provider to provide the strength
`on the rescri ntion for
`M“)
`
`The prefixes and infixes of this name pair have
`sufficient orthographic differences.
`
`E lusa has an extra 3 llable.
`
`The infixes of this name pair have sufficient
`orthographic differences.
`
`The second and third syllables of this name pair sound
`different.
`
`The infixes of this name pair have sufficient
`orthographic differences.
`
`
`
`The first and second syllables of this name pair sound
`Eucrisa different.
`56
`
`
`
`3.:
`
`This document contains proprietary information that caimot be released to the public***
`
`Reference ID: 3870779
`
`14
`
`

`

`No.
`
`19.
`
`20.
`
`21.
`
`22.
`
`Proposed name: Epclusa
`Established name:
`sofosbuvir and velpatasvir
`Dosage form: tablets
`Strength(s): 400/100 mg
`Usual Dose: One tablet once
`daily
`
`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 prefixes and infixes of this name pair have
`sufficient orthographic differences.
`The first, second, and third syllables of this name pair
`sound different.
`DHC Plus has an extra syllable.
`The prefixes and infixes of this name pair have
`sufficient orthographic differences.
`The second and third syllables of this name pair sound
`different.
`The prefixes of this name pair have sufficient
`orthographic differences.
`The first and second syllables of this name pair sounds
`different.
`The prefixes and infixes of this name pair have
`sufficient orthographic differences.
`The first, second, and third syllables of this name pair
`sound different.
`
`54
`
`52
`
`50
`
`50
`
`DHC Plus
`
`***
`
`Ellura
`
`ESGIC-Plus
`
`Appendix F: Low Similarity Names (e.g., combined POCA score is ≤49%)
`
`Name
`
`No.
`
`23.
`24.
`25.
`26.
`
`D3Plus
`Epiduo
`Epivir
`Epzicom
`
`POCA
`Score (%)
`≤49%
`≤49%
`≤49%
`≤49%
`
`***This document contains proprietary information that cannot be released to the public***
`
`Reference ID: 3870779
`
`15
`
`(b) (4)
`
`

`

`Name
`
`No.
`
`27.
`28.
`29.
`
`Ella
`Elta
`Eylea
`
`POCA
`Score (%)
`≤49%
`≤49%
`≤49%
`
`Appendix G: Names not likely to be confused or not used in usual practice settings for
`the reasons described.
`
`No.
`
`30.
`
`31.
`
`32.
`
`33.
`
`34.
`
`Name
`
`POCA
`Score
`(%)
`
`Failure preventions
`
`Name identified in RxNorm
`database.
`Unable to find product
`characteristics in commonly
`used drug databases.
`Name identified in RxNorm
`database.
`Unable to find product
`characteristics in commonly
`used drug databases.
`Name identified in RxNorm
`database.
`Unable to find product
`characteristics in commonly
`used drug databases.
`Not a drug.
`This is a liquid base used
`for compounding.
`Proposed proprietary name
`withdrawn by Applicant
`7/14/2011.
`Product approved under
`Bethkis.
`
`60
`
`54
`
`54
`
`54
`
`53
`
`Eco-Plus
`
`Eescula
`
`Epiflur
`
`PCCA-Plus
`
`***
`
`***This document contains proprietary information that cannot be released to the public***
`
`Reference ID: 3870779
`
`16
`
`(b) (4)
`
`

`

`No.
`
`35.
`
`Name
`
`POCA
`Score
`(%)
`
`Failure preventions
`
`Name identified in RxNorm
`database.
`Unable to find product
`characteristics in commonly
`used drug databases.
`
`DSS Plus
`
`52
`
`Appendix H: Names not likely to be confused due to notable spelling, orthographic and
`phonetic differences.
`No.
`
`Name
`
`POCA
`Score (%)
`60
`60
`56
`56
`55
`55
`54
`52
`52
`50
`50
`50
`50
`50
`50
`
`36.
`37.
`38.
`39.
`40.
`41.
`42.
`43.
`44.
`45.
`46.
`47.
`48.
`49.
`50.
`
`ASCLERA
`CYCLESSA
`Alcloxa
`
`***
`
`APTIVUS
`Replesta
`Incruse
`Biclora
`Isclofen
`Aclacin
`Actilyse
`OPCON-A
`Proluxa
`***
`VENCLEXTA***
`
`***This document contains proprietary information that cannot be released to the public***
`
`Reference ID: 3870779
`
`17
`
`(b) (4)
`
`(b) (4)
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`MONICA M CALDERON
`01/08/2016
`
`BRENDA V BORDERS-HEMPHILL
`01/08/2016
`
`Reference ID: 3870779
`
`