CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`208745Orig1s000
`
`PROPRIETARY NAME REVIEW(S)
`
`
`
`
`
`
`
`
`

`

`PROPRIETARY NAME MEMORANDUM
`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:
`September 8, 2016
`Application Type and Number: NDA 208745
`Product Name and Strength:
`Trulance (plecanatide) Oral Tablets, 3 mg
`Product Type:
`Single Ingredient Product
`Rx or OTC:
`Rx
`Applicant/Sponsor Name:
`Synergy Pharmaceuticals
`Panorama #:
`2016-2862855-1
`DMEPA Primary Reviewer:
`Matthew Barlow, RN, BSN
`DMEPA Team Leader:
`Mishale Mistry, PharmD, MPH
`
`Reference ID: 3983405
`
`

`

`1
`
`INTRODUCTION
`
`This memorandum is to reassess the proposed proprietary name, Trulance, based the revised
`strength and dose. The proposed proprietary name, Trulance, was found conditionally acceptable
`under IND
`(”wand NDA 208745 on May 11, 2016.a We previously reviewed the product with
`(m4) dose of 3 mg
`(m4) taken once daily with or without food.
`During review of the application, the proposed strength is 3 mg and the proposed dose is 3 mg
`taken once daily with or without food.
`
`2 METHODS AND DISCUSSION
`
`2.1
`
`SAFETY ASSESSMENT
`
`For re-assessment of the proposed proprietary name, DMEPA evaluated the previously identified
`names taking into account the change in strength and dose. Our evaluation has not altered our
`previous conclusion regarding the acceptability of the proposed proprietary name.
`
`Additionally, DMEPA searched the USAN stem list to determine if the name contains any
`USAN stems as of the last USAN updates. The August 30, 2016 search of USAN stems did not
`find any USAN stems in the proposed proprietary name.
`
`3 CONCLUSIONS
`
`Our re—assessment did not identify any names that represent a potential source of drug name
`confusion. Therefore, we maintain that the proposed proprietary name is acceptable from a
`promotional and safety perspective.
`
`If you have any questions or need clarifications, please contact Ginneh Stowe, OSE project
`manager, at 301-796-4049.
`
`‘ [Barlow, M]. Proprietary Name Review for [Trulance (NDA 208745 & IND {6(0)} Silver Spring (MD): Food
`and Drug Administration, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology.
`Division of Medication Error Prevention and Analysis (US); [2016 May 16]. Panorama No. [2016-2862855].
`
`Reference ID: 3983405
`
`

`

`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.
`
`Reference ID: 3983405
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`MATTHEW J BARLOW
`09/08/2016
`
`MISHALE P MISTRY
`09/08/2016
`
`Reference ID: 3983405
`
`

`

`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:
`May 11, 2016
`Application Type and Number:
`IND 74883 & NDA 208745
`Product Name and Strength:
`Trulance (plecanatide) Oral Tablets 3 mg
`Product Type:
`Single Ingredient Product
`Rx or OTC:
`Rx
`Applicant/Sponsor Name:
`Synergy Pharmaceuticals
`Panorama #:
`2015-2032572 & 2016-2862855
`DMEPA Primary Reviewer:
`Matthew Barlow, RN, BSN
`DMEPA Team Leader (Acting): Mishale Mistry, PharmD, MPH
`
`
`
`Reference ID: 3929981
`
`(b)(4)
`
`

`

`1
`
`2
`
`Contents
`INTRODUCTION........................................................................................................1
`1.1
`Regulatory History................................................................................................1
`1.2
`Product Information ..............................................................................................1
`RESULTS.....................................................................................................................1
`2.1 Misbranding Assessment ......................................................................................1
`2.2
`Safety Assessment.................................................................................................1
`CONCLUSIONS..........................................................................................................3
`3.1
`Comments to the Applicant...................................................................................3
`REFERENCES.............................................................................................................4
`4
`APPENDICES .....................................................................................................................5
`
`3
`
`
`
`Reference ID: 3929981
`
`

`

`1
`
`INTRODUCTION
`
`This review evaluates the proposed proprietary name, Trulance, 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 (am), for this product.
`
`1.1
`
`REGULATORY HISTORY
`
`The Applicant submitted the proposed proprietary name, Trulance*** on November 18,
`2015 under IND 74883, and on February 23, 2016 under NDA 208745.
`
`1.2
`
`PRODUCT INFORMATION
`
`The following product information is provided in the November 18, 2015 & February 23,
`2016 proprietary name submission.
`
`0
`
`Intended Pronunciation:
`
`troo' lans
`
`0 Active Ingredient: plecanatide
`
`o
`
`Indication of Use: Chronic idiopathic constipation (CIC)
`
`0 Route of Administration: Oral
`
`o Dosage Form: Tablets
`
`0
`
`Strength: 3 mg,
`
`(hm
`
`0 Dose and Frequency: One tablet (3 mg
`
`(hm) once daily
`
`0 How Supplied: Blister Packs or Bottles
`
`0
`
`Storage: Store at room temperature. Keep in original container/packaging to
`protect from moisture. (if distributed in bottles: Do not remove the desiccant from
`inside the bottle)
`
`0 Container and Closure Systems: N/A
`
`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
`Gastroenterology & Inborn Error Products (DGIEP) 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.
`
`Reference ID: 3929981
`
`1
`
`

`

`2.2.1 United States Adopted Names (USAN) Search
`There is no USAN stem present in the proprietary name1.
`
`2.2.2 Components of the Proposed Proprietary Name
`The Applicant did not provide a derivation or intended meaning for the proposed name,
`Trulance 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
`67 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. 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, December 7, 2015 and March 2, 2016 e-mail, the Division of
`Gastroenterology & Inborn Error Products (DGIEP) 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
`FDA Prescription Simulation Study or by the
` external 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
`2
`
`212
`
`6
`
`1USAN stem search conducted on November 23, 2015.
`
`2 POCA search conducted on November 23, 2015.
`
`Reference ID: 3929981
`
`2
`
`(b) (4)
`
`

`

`2.2.6 Safety Analysis of Names with Potential Orthographic, Spelling, and Phonetic
`Similarities
`Our analysis of the 220 names contained in Table 1 determined that none of the names
`will pose a risk for confusion as described in Appendices C through H.
`
`2.2.7 Communication of DMEPA’s Analysis at Midpoint of Review
`DMEPA communicated our findings to the Division of Gastroenterology & Inborn Error
`Products (DGIEP) via e-mail on May 6, 2016. At that time we also requested additional
`information or concerns that could inform our review. DGIEP did not state additional
`concerns with the proposed proprietary name.
`
`3 CONCLUSIONS
`The proposed proprietary name is acceptable.
`If you have any questions or need clarifications, please contact Alek Winiarski, OSE
`project manager, at 301-796-5295.
`
`COMMENTS TO THE APPLICANT
`3.1
`We have completed our review of the proposed proprietary name, Trulance, and have
`concluded that this name is acceptable.
`If any of the proposed product characteristics as stated in your November 18, 2015 and
`February 23, 2016 submission are altered prior to approval of the marketing application,
`the name must be resubmitted for review.
`
`Reference ID: 3929981
`
`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: 3929981
`
`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: 3929981
`
`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: 3929981
`
`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: 3929981
`
`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: 3929981
`
`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: 3929981
`
`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: 3929981
`
`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: 3929981
`
`11
`
`

`

`Appendix B: Prescription Simulation Samples and Results
`
`Figure l. Trulance Study {Conducted on December 11: 2015)
`
`Handwritten Re u uisition Medication Order
`
`Verbal Prescri n tion
`
`_‘ 7;
`
`Medication Order:
`
`/
`
`.
`.
`.
`Outpatlent Prescnptlon:
`
`.’.;
`f/LL‘UitL/L,
`
`V" ‘
`‘LJI-Cfl
`
`1.A _‘
`Tu;
`
`Trulance 3 mg
`
`Take one tablet by mouth once
`daily
`
`Disp #30
`
`FDA Prescription Simulation Responses (Aggregate 1 Rx Studies Report!
`
`Study Name: Trulance
`Total
`
`23
`
`23
`
`21
`
`INTERPRETATION OI'TPATIENT
`
`VOICE
`
`INPATIENT TOTAL
`
`Bo
`
`31H
`
`2o
`
`gh‘
`
`I—Ii—II—ir—ll—ID—ll—li—l
`HOOOOOOO
`OOOOOOCO
`Oi—II—ir—ll—ID—ll—li—l
`
`TRULAM
`
`TRULANCE
`
`TRULAND
`
`TRULANTS
`
`TRULANZE
`
`TRULENCE
`
`TRULENS
`
`TRULENZE
`
`TRULITZ
`
`TULANCE
`
`Reference ID: 3929981
`
`12
`
`

`

`Appendix C: Highly Similar Names (e.g., combined POCA score is 270%)
`
`_- msnameisthesub'ectomereview.
`
`This proposed proprietary name was found unacceptable
`
`the . y n lication.
`
`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
`
`The sponsor withdrew
`A -—
`
`-—
`fl—
`-—
`\1
`M—
`M—
`l!!—
`m—
`m—
`-—
`-—
`-—
`fl—
`
`58%
`
`Reference ID: 3929981
`
`13
`
`

`

`No.
`
`Name
`
`17. Mitrolan
`18.
`Rosula NS
`19.
`Prolintane
`20.
`Tri-Luma
`21.
`Triple Dye
`22.
`Trivase
`23.
`Oro Cleanse
`24.
`Trancot
`25.
`Triacet
`26.
`Tri Levlen
`27.
`Tri-Linyah
`28.
`Jardiance
`29.
`Sunbalance
`30.
`T-Tussin PE
`31.
`Trintex
`32.
`Talacen
`33.
`Tranmep
`34.
`Trelstar
`35.
`Tridrane
`36.
`Trinessa
`37.
`Triple Paste
`38.
`Tri-Tannate
`39.
`Exuviance
`40.
`Triban
`41.
`Triblide
`42.
`Trientine
`43.
`Triglide
`44.
`Trobicin
`45.
`Tritan
`46.
`Tretin X
`
`Reference ID: 3929981
`
`POCA
`Score (%)
`58%
`58%
`58%
`57%
`57%
`57%
`57%
`56%
`56%
`56%
`56%
`56%
`56%
`56%
`55%
`54%
`54%
`54%
`54%
`54%
`54%
`54%
`54%
`53%
`53%
`53%
`53%
`53%
`53%
`52%
`
`14
`
`

`

`No.
`
`Name
`
`47.
`48.
`49.
`50.
`51.
`52.
`53.
`54.
`55.
`56.
`57.
`58.
`59.
`60.
`61.
`62.
`63.
`64.
`65.
`66.
`67.
`68.
`69.
`70.
`71.
`72.
`73.
`74.
`75.
`76.
`
`Tri Lo Mili
`Tri-Legest
`Tri-Legest 21
`Tri-Lo-Mili
`Trimo San
`Tri-Pase
`Tri Vent HC
`Glucovance
`Trental
`Tronothane
`Probalan
`Spirulina
`Triplex AD
`Tencet
`
`***
`
`Titralac
`Tradjenta
`Travatan
`Travatan Z
`Travenol
`Trav-L-Tabs
`Treagan
`Triactin
`Trialodine
`Triatex
`Tribulus
`Tri-Legest FE
`Triphasil-21
`Triphasil-28
`Truxazole
`
`Reference ID: 3929981
`
`POCA
`Score (%)
`52%
`52%
`52%
`52%
`52%
`52%
`52%
`52%
`51%
`51%
`51%
`51%
`51%
`50%
`50%
`50%
`50%
`50%
`50%
`50%
`50%
`50%
`50%
`50%
`50%
`50%
`50%
`50%
`50%
`50%
`
`15
`
`(b)(4)
`
`

`

`No.
`
`77.
`78.
`79.
`80.
`81.
`82.
`
`Name
`
`Truxcillin
`Trypan Blue
`Tusscidin PE
`Norplant
`Oxy 10 Balance
`Oxy Balance
`
`POCA
`Score (%)
`50%
`50%
`50%
`50%
`50%
`50%
`
`Reference ID: 3929981
`
`16
`
`

`

`Appendix E: Moderately Similar Names (e.g., combined POCA score is 250% to 369%)
`with overlap or numerical similarity in Strength and/or Dose
`
`
`POCA
`Proposed name: Trulance
`Established name:
`Score (%)
`Plecanatide
`
`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
`
`Dosage form: Oral Tablet
`
`Strength(s): 3 mg, m
`
`Usual Dose: One tablet once
`
`
`
`
`
`
`The infix of this name pair has sufficient orthographic
`differences.
`
`The first and second syllables of this name pair sound
`different.
`
`This name contains an additional syllable.
`
`The prefix of this name pair has sufficient orthographic
`differences.
`
`The first and last syllables of this name pair sound
`different.
`
`This name contains an additional 5 llable.
`
`66%
`
`64%
`
`64%
`
`The suffix of this name pair has sufficient orthographic
`differences.
`
`The last 3 llable of this name air sound different.
`
`The prefix and infix of this name pair have sufficient
`orthographic differences.
`
`The first syllable of this name pair sounds different.
`
`The prefix of this name pair has sufficient orthographic
`differences.
`
`The first/second syllable of this name pair sounds
`different.
`
`
`
`
`
`The prefix of this name pair has sufficient orthographic
`differences
`
`
`The first syllables of this name pair sound different.
`
`2.
`
`Triesence
`
`4.
`
`Trilone
`
`5_
`
`marital:
`
`6.
`
`Rebalance
`
`
`
`
`This name contains an additional syllable.
`
`Reference ID: 3929981
`
`17
`
`

`

`Established name:
`
`Plecanatide
`
`POCA
`Score (%)
`
`Dosage form: Oral Tablet
`Strength(s): 3 mg, m
`
`Usual Dose: One tablet once
`
`64%
`
`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 prefix of this name pair has sufficient orthographic
`diff