CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`208082Orig1s000
`
`PROPRIETARY NAME REVIEW(S)
`
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`

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`PROPRIETARY NAME REVIEW
`Division of Medication Error Prevention and Analysis (DMEPA)
`Office of Medication Error Prevention and Risk Management (OMEPRM)
`Office of Surveillance and Epidemiology (OSE)
`Center for Drug Evaluation and Research (CDER)
`
`*** This document contains proprietary information that cannot be released to the
`public***
`
`Date of This Review:
`Application Type and Number:
`Product Name and Strength:
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Team Leader:
`
`January 10, 2017
` and NDA 208082
`Austedo (deutetrabenazine) Tablets
`6 mg, 9 mg, and 12 mg
`Single Ingredient Product
`Rx
`Teva Pharmaceuticals, Inc.
`2016-10567133 and 2016-10808890
`Loretta Holmes, BSN, PharmD
`Lolita White, PharmD
`
`Reference ID: 4040129
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`(b) (4)
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`

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`1
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`2
`
`Contents
`INTRODUCTION....................................................................................................................1
`1.1
`Regulatory History............................................................................................................1
`1.2
`Product Information ..........................................................................................................1
`RESULTS.................................................................................................................................2
`2.1 Misbranding Assessment ..................................................................................................2
`2.2
`Safety Assessment.............................................................................................................2
`CONCLUSIONS......................................................................................................................4
`3.1
`Comments to the Applicant...............................................................................................4
`REFERENCES.........................................................................................................................5
`4
`APPENDICES .................................................................................................................................6
`
`3
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`
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`Reference ID: 4040129
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`

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`INTRODUCTION
`1
`This review evaluates the proposed proprietary name, Austedo, 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.
`
`REGULATORY HISTORY
`1.1
`The proposed proprietary name, Austedo was previously submitted to IND 112975 on November
`18, 2014 and NDA 208082 on May 29, 2015 for the treatment of chorea associated with
`Huntington’s disease (these applications are covered by the Division of Neurology Products).
`The Division of Medication Error Prevention and Analysis found the name conditionally
`acceptable in OSE Review #2014-43007, dated February 24, 2015a and OSE Review
`#2015-650424, dated June 22, 2015b, under the IND and NDA, respectively. The NDA
`application received a Complete Response (CR) action on May 27, 2016.
`Teva most recently submitted a proprietary name review request for Austedo to
` on
`October 4, 2016 for
` (this application is covered
`by the Division of Psychiatry Products) and to NDA 208082 on October 17, 2016 for the
`treatment of chorea associated with Huntington’s disease (the NDA was resubmitted on October
`3, 2016 in response to the May 27, 2016 CR action).
`
`PRODUCT INFORMATION
`1.2
`The following product information is provided in the October 4, 2016
`October 17, 2016 (NDA 208082) proprietary name submissions.
`Intended Pronunciation: ah-STED-oh
`
` Active Ingredient: deutetrabenazine
`Indication of Use: Treatment of chorea associated with Huntington’s Disease;
`
`
` and
`
`
`
` Route of Administration: Oral
` Dosage Form: Tablets
` Strengths: 6 mg, 9 mg, and 12 mg
` Dose and Frequency: The usual dosage for this product is 6 mg to 24 mg. The frequency
`of administration is once to twice daily. Daily doses of 12 mg and higher per day should
`be given in two divided doses. The maximum daily dose is 48 mg.
`
`a Harris, J. Proprietary Name Review for Austedo (IND 112975). 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); 2015 Feb 24. 19 p. OSE RCM No.: 2014-43007.
`
`b Harris, J. Proprietary Name Review for Austedo (NDA 208082). 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); 2015 Jun 22. 2 p. OSE RCM No.: 2015-650424.
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`Reference ID: 4040129
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` How Supplied: 60-count bottles
` Storage: Store at 25º C (77º F); excursions permitted to 15-30ºC (59-86º F)
` bottle
` Container and Closure Systems:
`
`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 Psychiatry Products (DPP) and
`the Division of Neurology Products (DNP) 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 namec.
`
`2.2.2 Components of the Proposed Proprietary Name
`The Applicant indicated in their submission that the proposed name, Austedo, is not derived
`from any one particular concept. 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
`Eighty-three (83) practitioners participated in DMEPA’s prescription studies. One participant in
`the verbal prescription study interpreted the name as “Astero” which is phonetically similar to
`the name of the currently marketed product, Astepro. However, we believe that Austedo and
`Astepro are unlikely to be confused due to product characteristic differences (see
`Appendix C).
`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, October 14, 2016 e-mail, the Division of Psychiatry Products (DPP) did
`not forward any comments or concerns relating to the proposed proprietary name at the initial
`phase of the review.
`
`c USAN stem search conducted on December 13, 2016.
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`Reference ID: 4040129
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`In response to the OSE, October 21, 2016 e-mail, the Division of Neurology Products (DNP) 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
`
`We had identified and evaluated 60 names in our previous proprietary name review.d Our new
`POCA search identified 64 names with the combined score of ≥55%. In this review, we re-
`evaluated one of the names identified in the previous review because the combined POCA score
`with the revised POCA algorithm is now ≥70% whereas a lower combined score was retrieved in
`the previous review. Additionally, we re-evaluated the previously identified names of concern
`considering any lessons learned from recent post-marketing experience, which may have altered
`our previous conclusion regarding the acceptability of the name. We acknowledge the addition
`of a new indication
` since our previous review of the proprietary
`name; however, the strengths, dosages and other product characteristics have not changed. We
`agree with the findings from our previous review for the names evaluated previously. Therefore,
`Table 1 lists the 28 names not previously analyzed with the combined orthographic and phonetic
`score of ≥55% retrieved from our POCA search organized as highly similar, moderately similar
`or low similarity for further evaluation. In addition to these 28 names, Table 1 also includes:
`one name from our previous proprietary name review which now has a combined score of
`
`≥70% as a result of the POCA update
`four names identified by
`
` but not retrieved in our POCA search
`
`
`
`
`
`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
`1
`
`28
`
`4
`
`2.2.6 Names with Potential Orthographic, Spelling, and Phonetic Similarities that overlap in
`strength
`The proposed product, Austedo, will be available in strengths of 6 mg, 9 mg, and 12 mg. Since
`9 mg is not a typical strength that is commonly marketed, we searched the Electronic Drug
`Registration and Listing System (eDRLS) database to identify any names with an overlap in
`strength and potential orthographic, spelling, and phonetic similarities with Austedo that were
`not identified in POCA.
`
`d Harris J. Proprietary Name Review for Austedo IND 112975. Silver Spring (MD): FDA, CDER, OSE, DMEPA
`(US); 2015 Feb 24. 17 p. OSE Review No.: 2014-43007.
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`Reference ID: 4040129
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` Table 1A. eDRLS Search Resultse
`N/A
`
`POCA Score (%)
`
`2.2.7 Safety Analysis of Names with Potential Orthographic, Spelling, and Phonetic
`Similarities
`Our analysis of the 33 names contained in Table 1 determined none of the names will 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 Neurology Products (DNP) via e-mail on
`January 4, 2017. At that time we also requested additional information or concerns that could
`inform our review. Per e-mail correspondence from DNP on January 6, 2017, they stated no
`additional concerns with the proposed proprietary name, Austedo.
`DMEPA communicated our findings to the Division of Psychiatry Products (DPP) via e-mail on
`January 4, 2017. At that time we also requested additional information or concerns that could
`inform our review. Per e-mail correspondence from DPP on January 10, 2017, they stated no
`additional concerns with the proposed proprietary name, Austedo.
`
`3 CONCLUSIONS
`The proposed proprietary name is acceptable.
`If you have any questions or need clarifications, please contact Ruth Maduro, OSE Project
`Manager, at 240-402-4232 (for DNP concerns) or Alycia Anderson, OSE Project Manager, at
`240-402-4270 (for DPP concerns).
`
`COMMENTS TO THE APPLICANT
`3.1
`We have completed our review of the proposed proprietary name, Austedo, and have concluded
`that this name is acceptable.
`A request for proprietary name review for Austedo should be submitted once the NDA for the
` indication is submitted.
`
`If any of the proposed product characteristics as stated in your October 4, 2016
`and October 17, 2016 (NDA 208082) submissions are altered prior to approval of the marketing
`application, the name must be resubmitted for review.
`
`e eDRLS search conducted on December 12, 2016.
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`Reference ID: 4040129
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`4
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`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.
`3. 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).
`
`4. 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#).
`
`5. 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.
`
`6. 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.
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`Reference ID: 4040129
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`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. f
`*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
`
`f National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors.html. Last accessed 10/11/2007.
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`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.
`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 ≥55% to ≤ 69%.
`• Low similarity: combined match percentage score ≤54%.
`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).
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` 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.
`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
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`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.
`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?
`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?
`
`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?
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`Y/N Do the suffixes of the names appear
`dissimilar when scripted?
`
`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.
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`Reference ID: 4040129
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`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%).
`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: 4040129
`
`11
`
`

`

`Appendix B: Prescription Simulation Samples and Results
`Figure 1. Austedo Study (Conducted on December 16, 2016)
`
`Handwritten Medication Order/Prescription
`Medication Order:
`
`Outpatient Prescription:
`
`Verbal Prescription
`Austedo 12 mg
`Take 1 tablet by mouth twice
`daily
`Disp. #60
`
`FDA Prescription Simulation Responses (Aggregate 1 Rx Studies Report)
`
`Study Name: Austedo
`Total
`INTERPRETATION
`ACEADO
`ARUSTEDO
`ASTERO
`ASTETTO
`AULTEDO
`AULTIDO
`AURSTEDO
`AURTEDO
`AUSTEDO
`AUSTETO
`
`26
`OUTPATIENT
`0
`0
`0
`0
`0
`0
`0
`0
`4
`0
`
`27
`VOICE
`1
`0
`1
`1
`0
`0
`0
`0
`2
`1
`
` 307 People Received Study
` 83 People Responded
`
`30
`INPATIENT
`0
`1
`0
`0
`1
`2
`1
`2
`13
`0
`
`
`TOTAL
`1
`1
`1
`1
`1
`2
`1
`2
`19
`1
`
`Reference ID: 4040129
`
`12
`
`

`

`AUSTETTO
`AUSTIDO
`DIUSTEDO
`DRULTIDO
`DURSTEDO
`LUSTEDO
`ORUSTEDO
`OSTEADO
`OSTEDO
`OSTELLO
`OSTENO
`OSTETO
`OSTETTO
`OURITEDO
`OURSTEDO
`SURITIDO
`SUSTEDO
`
`0
`0
`0
`0
`0
`1
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`21
`
`1
`0
`0
`0
`0
`0
`0
`1
`6
`1
`1
`6
`5
`0
`0
`0
`0
`
`0
`2
`1
`1
`1
`0
`2
`0
`0
`0
`0
`0
`0
`1
`1
`1
`0
`
`1
`2
`1
`1
`1
`1
`2
`1
`6
`1
`1
`6
`5
`1
`1
`1
`21
`
`Reference ID: 4040129
`
`13
`
`

`

`No.
`
`1.
`
`Other prevention of failure mode expected to
`minimize the risk of confusion between these two
`names.
`
`Appendix C: Highly Similar Names (e.g., combined or individual POCA score is ≥70%)
`
`Proposed name: POCA
`Orthographic and/or phonetic differences in the
`Score
`names sufficient to prevent confusion
`Austedo
`(%)
`Established name:
`deutetrabenazine
`Dosage form:
`Tablets
`Strengths:
`6 mg, 9 mg, and 12 mg
`Usual Dose:
`6 mg to 24 mg once to twice
`daily. Daily doses of 12 mg
`and higher per day should
`be given in two divided
`doses. The maximum daily
`dose is 48 mg.
`Astepro
`
`70
`
`The suffixes of this name pair (“-do” vs. “-pro”) have
`sufficient orthographic differences due to the upstroke
`letter “d” in Austedo vs. the downstroke letter “p” and
`adjacent letter “r” in Astepro.
`
`The onset of the third syllables of this name pair (“-do”
`vs. “-pro”) sound different.
`
`The products differ in dosage form (tablet vs. nasal
`spray); strengths (6 mg, 9 mg, and 12 mg vs. 0.15%);
`and dose (6 mg to 24 mg vs. 1 or 2 sprays). These
`differences will help to minimize the potential for
`confusion to occur.
`
`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
`
`1.
`2.
`3.
`4.
`5.
`
`Antabuse
`Ascot
`Atuss DS
`Stendra
`
`POCA
`Score (%)
`56
`58
`55
`58
`58
`
`***This document contains proprietary information that cannot be released to the public***
`
`Reference ID: 4040129
`
`14
`
`(b) (4)
`
`

`

`Appendix E: Moderately Similar Names (e.g., combined POCA score is ≥55% to ≤69%) with
`overlap or numerical similarity in Strength and/or Dose
`
`Proposed name: POCA
`Prevention of Failure Mode
`Austedo
`Score
`(%)
`Established name:
`deutetrabenazine
`Dosage form:
`Tablets
`Strengths:
`6 mg, 9 mg, and 12 mg
`Usual Dose:
`6 mg to 24 mg once to twice
`dai