CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`209803Orig1s000
`209805Orig1s000
`209806Orig1s000
`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:
`March 22, 2017
`Application Type and Number: NDA 209803
`Product Name and Strength:
`Steglatro (ertugliflozin) tablets, 5 mg and 15 mg
`Product Type:
`Single Ingredient Product
`Rx or OTC:
`Rx
`Applicant/Sponsor Name:
`Merck Sharp & Dohme Corp.
`Panorama #:
`2017-12352707
`DMEPA Primary Reviewer:
`Casmir Ogbonna, PharmD, MBA, BCPS, BCGP
`DMEPA Team Leader:
`Hina Mehta, PharmD
`
`Reference ID: 4073142
`
`

`

`1
`
`Contents
`INTRODUCTION....................................................................................................................1
`1.1
`Regulatory History............................................................................................................1
`1.2
`Product Information ..........................................................................................................1
`2 RESULTS.................................................................................................................................2
`2.1 Misbranding Assessment ..................................................................................................2
`2.2
`Safety Assessment.............................................................................................................2
`3 CONCLUSIONS......................................................................................................................3
`3.1
`Comments to the Applicant...............................................................................................4
`4 REFERENCES.........................................................................................................................5
`APPENDICES .................................................................................................................................6
`
`
`
`Reference ID: 4073142
`
`

`

`1
`
`INTRODUCTION
`
`This review evaluates the proposed proprietary name, Steglatro, 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 did not submit an external name
`study for this proposed proprietary name.
`
`1.1
`
`REGULATORY HISTORY
`
`The Applicant previously submitted the proposed proprietary name, Steglatro on January 6,
`2016. The Division of Medication Error Prevention and Analysis (DIVIEPA) found the name,
`Steglatro, acceptable on April 6, 2016 under OSE# 2016-2484877.al
`
`1.2
`
`PRODUCT INFORMATION
`
`The following product information is provided in the January 4, 2017 proprietary name
`submission:
`
`0
`
`Intended Pronunciation: steh—GLA—troh
`
`0 Active Ingredient: ertugliflozin
`
`o
`
`Indication of Use: Treatment of patients with Type 2 diabetes mellitus
`
`0 Route of Administration: Oral
`
`o Dosage Form: Tablets
`
`0
`
`Strength: 5 mg, 15 mg
`
`0 Dose and Frequency: Recommended starting dose is 5 mg once daily in the morning with
`or without food. In patients tolerating 5 mg who require additional glycemic control, the
`dose may be increased to 15 mg once daily.
`
`
`
`
`
`How Su lied:
`
`
`
`
`Tablet Strength
`"’""
`7 (7 days), 30 (30 days), 75 cc HDPE
`5 mg and 15 mg
`
`
`90 (90 days)
`
`
`
`5 mg
`500 (bulk)
`120 cc HDPE
`
`
`
`HUD Unit Dose: unit
`Foil/foil blister
`5mgand 15mg
`dose foil/foil blisters {'3
`(II) n
`
`
`
`Tablet Count
`
`
`
`
`
`0
`
`Storage: Store at USP Controlled Room Temperature (15°C-25°C). Protect from
`moisture.
`
`' Conrad. A. Proprietary Name Review for Steglatro IND 106447. Silver Spring (MD): FDA, CDER, OSE, DMEPA
`(US): 2016 April 06. RCM No.: 2016-2484877.
`
`Reference ID: 4073142
`
`1
`
`

`

` Container and Closure Systems: The intended trade package configuration consists of
`high-density polyethylene (HDPE) bottles
` for potential
`total product counts of weekly, 30-day and 90-day supply and pharmacy re-dispensing
`bottles of 500s
`. The intended sample package configuration will be
`a weekly HDPE bottle. The intended hospital unit dose (HUD) package is unit dose
`foil/foil blisters
`.
`
`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 Metabolism and
`Endocrinology Products (DMEP) 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 nameb.
`
`2.2.2 Components of the Proposed Proprietary Name
`The Applicant did not provide a derivation or intended meaning for the proposed name, Steglatro
`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
`Ninety (90) 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, January 24, 2017 e-mail, the Division of Metabolism and Endocrinology
`Products (DMEP) did not forward any comments or concerns relating to the proposed
`proprietary name at the initial phase of the review in their January 26, 2017 email.
`
`2.2.5 Phonetic and Orthographic Computer Analysis (POCA) Search Results
`
`b USAN stem search conducted on January 27, 2017.
`
`Reference ID: 4073142
`
`2
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`Our POCAc search identified 56 names with the combined score of ≥55%. We had identified and
`evaluated 84 names in our previous proprietary name review; however, we re-evaluated one
`name in this review as the combined POCA score with the revised POCA algorithm is  70.d 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 note that none of the product characteristics have changed and we
`agree with the findings from our previous review for the names evaluated previously.
`Therefore, Table 1 lists the 32 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. Table 1 also lists one name from our
`previous proprietary name review with a combined score of  70% as a result of the update in
`POCA. Additionally, Table 1 lists 27 names with a combined orthographic and phonetic score
`of <55% and orthographic score > 70%.
`
`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
`
`55
`
`4
`
`2.2.6 Safety Analysis of Names with Potential Orthographic, Spelling, and Phonetic
`Similarities
`Our analysis of the 60 names contained in Table 1 will not 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 Metabolism and Endocrinology Products
`(DMEP) via e-mail on March 16, 2017. At that time we also requested additional information or
`concerns that could inform our review. Per e-mail correspondence from the DMEP on March
`21, 2017, they stated no additional concerns with the proposed proprietary name, Steglatro.
`
`3 CONCLUSIONS
`The proposed proprietary name is acceptable.
`
`c POCA search conducted on February 08, 2017 in version 4.0
`
`d Conrad, A. Proprietary Name Review for Steglatro (IND 106447). 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 April 6. Panorama No. 2016-2484877.
`
`Reference ID: 4073142
`
`3
`
`

`

`If you have any questions or need clarifications, please contact Terrolyn Thomas, OSE project
`manager, at 240-402-3981.
`
`COMMENTS TO THE APPLICANT
`3.1
`We have completed our review of the proposed proprietary name, Steglatro, and have concluded
`that this name is acceptable.
`If any of the proposed product characteristics as stated in your January 4, 2017 submission are
`altered prior to approval of the marketing application, the name must be resubmitted for review.
`
`Reference ID: 4073142
`
`4
`
`

`

`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: 4073142
`
`5
`
`

`

`APPENDICES
`Appendix A
`FDA’s Proprietary Name Risk Assessment evaluates proposed proprietary names for
`misbranding and safety concerns.
`1. Misbranding Assessment: For prescription drug products, OPDP assesses the name for
`misbranding concerns. . For over-the-counter (OTC) drug products, the misbranding
`assessment of the proposed name is conducted by DNDP. OPDP or DNDP evaluates
`proposed proprietary names to determine if the name is false or misleading, such as by
`making misrepresentations with respect to safety or efficacy. For example, a fanciful
`proprietary name may misbrand a product by suggesting that it has some unique
`effectiveness or composition when it does not (21 CFR 201.10(c)(3)). OPDP or DNDP
`provides their opinion to DMEPA for consideration in the overall acceptability of the
`proposed proprietary name.
`2. Safety Assessment: The safety assessment is conducted by DMEPA, and includes the
`following:
`a. Preliminary Assessment: We consider inclusion of USAN stems or other characteristics
`that when incorporated into a proprietary name may cause or contribute to medication
`errors (i.e., dosing interval, dosage form/route of administration, medical or product name
`abbreviations, names that include or suggest the composition of the drug product, etc.)
`See prescreening checklist below in Table 2*. DMEPA defines a medication error as any
`preventable event that may cause or lead to inappropriate medication use or patient harm
`while the medication is in the control of the health care professional, patient, or
`consumer. e
`
`e National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
`
`Reference ID: 4073142
`
`6
`
`

`

`*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 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: 4073142
`
`7
`
`

`

`b. Phonetic and Orthographic Computer Analysis (POCA): Following the preliminary
`screening of the proposed proprietary name, DMEPA staff evaluates the proposed name
`against potentially similar names. In order to identify names with potential similarity to
`the proposed proprietary name, DMEPA enters the proposed proprietary name in POCA
`and queries the name against the following drug reference databases, Drugs@fda,
`CernerRxNorm, and names in the review pipeline using a 55% threshold in POCA.
`DMEPA reviews the combined orthographic and phonetic matches and group the names
`into one of the following three categories:
`• Highly similar pair: combined match percentage score ≥70%.
`• Moderately similar pair: combined match percentage score ≥55% to ≤ 69%.
`• Low similarity: combined match percentage score ≤54%.
`Using the criteria outlined in the check list (Table 3-5) that corresponds to each of the three
`categories (highly similar pair, moderately similar pair, and low similarity), DMEPA
`evaluates the name pairs to determine the acceptability or non-acceptability of a proposed
`proprietary name. The intent of these checklists is to increase the transparency and
`predictability of the safety determination of whether a proposed name is vulnerable to
`confusion from a look-alike or sound-alike perspective. Each bullet below corresponds to the
`name similarity category cross-references the respective table that addresses criteria that
`DMEPA uses to determine whether a name presents a safety concern from a look-alike or
`sound-alike perspective.
` For highly similar names, differences in product characteristics often cannot mitigate the
`risk of a medication error, including product differences such as strength and dose. Thus,
`proposed proprietary names that have a combined score of ≥ 70 percent are at risk for a
`look-alike sound-alike confusion which is an area of concern (See Table 3).
` Moderately similar names are further evaluated to identify the presence of attributes that
`are known to cause name confusion.
` Name attributes: We note that the beginning of the drug name plays a
`significant role in contributing to confusion. Additionally, drug name pairs
`that start with the same first letter and contain a shared letter string of at
`least 3 letters in both names are major contributing factor in the confusion
`of drug namesf. We evaluate all moderately similar names retrieved from
`POCA to identify the above attributes. These names are further evaluated
`to identify overlapping or similar strengths or doses.
` Product attributes: Moderately similar names of products that have
`overlapping or similar strengths or doses represent an area for concern for
`FDA. The dose and strength information is often located in close
`proximity to the drug name itself on prescriptions and medication orders,
`and the information can be an important factor that either increases or
`decreases the potential for confusion between similarly named drug pairs.
`The ability of other product characteristics to mitigate confusion (e.g.,
`
`f Shah, M, Merchant, L, Characteristics That May Help in the Identification of Potentially Confusing Proprietary
`Drug Names. Therapeutic Innovation & Regulatory Science, September 2016
`
`Reference ID: 4073142
`
`8
`
`

`

`route, frequency, dosage form) may be limited when the strength or dose
`overlaps. DMEPA reviews such names further, to determine whether
`sufficient differences exist to prevent confusion. (See Table 4).
`
` Names with low similarity that have no overlap or similarity in strength and dose are
`generally acceptable (See Table 5) unless there are data to suggest that the name might be
`vulnerable to confusion (e.g., prescription simulation study suggests that the name is
`likely to be misinterpreted as a marketed product). In these instances, we would reassign
`a low similarity name to the moderate similarity category and review according to the
`moderately similar name pair checklist.
`
`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.
`
`Reference ID: 4073142
`
`9
`
`

`

`d. Comments from Other Review Disciplines: DMEPA requests the Office of New Drugs
`(OND) and/or Office of Generic Drugs (OGD), ONDQA or OBP for their comments or
`concerns with the proposed proprietary name, ask for any clinical issues that may impact
`the DMEPA review during the initial phase of the name review. Additionally, when
`applicable, at the same time DMEPA requests concurrence/non-concurrence with
`OPDP’s decision on the name. The primary Safety Evaluator addresses any comments or
`concerns in the safety evaluator’s assessment.
`The OND/OGD Regulatory Division is contacted a second time following our analysis of
`the proposed proprietary name. At this point, DMEPA conveys their decision to accept
`or reject the name. The OND or OGD Regulatory Division is requested to provide any
`further information that might inform DMEPA’s final decision on the proposed name.
`Additionally, other review disciplines opinions such as ONDQA or OBP may be
`considered depending on the proposed proprietary name.
`When provided, DMEPA considers external proprietary name studies conducted by or for
`the Applicant/Sponsor and incorporates the findings of these studies into the overall risk
`assessment.
`The DMEPA primary reviewer assigned to evaluate the proposed proprietary name is responsible
`for considering the collective findings, and provides an overall risk assessment of the proposed
`proprietary name.
`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
`
`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,
`
`Reference ID: 4073142
`
`10
`
`

`

`or deletion?
`
`Y/N Across a range of dialects, are
`the names consistently
`pronounced differently?
`
`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?
`
`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
`
`Reference ID: 4073142
`
`11
`
`

`

`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.
`
`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
`
`
`
`Reference ID: 4073142
`
`12
`
`

`

`scripted?
`
`Table 5: Low Similarity Name Pair Checklist (i.e., combined score is ≤54%).
`Names with low similarity are generally acceptable unless there are data to suggest that
`the name might be vulnerable to confusion (e.g., prescription simulation study suggests
`that the name is likely to be misinterpreted as a marketed product). In these instances,
`we would reassign a low similarity name to the moderate similarity category and
`review according to the moderately similar name pair checklist.
`
`Reference ID: 4073142
`
`13
`
`

`

`Appendix B: Prescription Simulation Samples and Results
`Figure 1. Steglatro Study (Conducted on January 27, 2017)
`
`Handwritten Medication Order/Prescription
`Medication Order:
`
`Verbal Prescription
`Steglatro 15mg
`Take 1 by mouth every morning.
`
`Outpatient Prescription:
`
`FDA Prescription Simulation Responses (Aggregate 1 Rx Studies Report)
`
`Study Name: Steglatro
`As of Date 2/13/2017
`
`
`297 People Received Study
`90 People Responded
`
`Study Name: Steglatro
`Total
`
`36
`
`27
`
`27
`
`
`
`INTERPRETATION
`
`OUTPATIENT
`
`VOICE
`
`INPATIENT
`
`TOTAL
`
`STAGLATRA
`
`STAGLATRO
`
`STEGFATRO
`
`STEGLATA
`
`STEGLATE
`
`STEGLATEO
`
`0
`
`0
`
`0
`
`3
`
`20
`
`2
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`1
`
`1
`
`1
`
`0
`
`0
`
`0
`
`1
`
`1
`
`1
`
`3
`
`20
`
`2
`
`Reference ID: 4073142
`
`14
`
`

`

`STEGLATI
`
`STEGLATIO
`
`STEGLATIS
`
`STEGLATRA
`
`STEGLATRO
`
`STICKLATRO
`
`STICKLATROW
`
`STICKLATTRO
`
`STICLATO
`
`STICLATRO
`
`STIGLANTRO
`
`STIGLATO
`
`STIGLATRO
`
`STIKLATRO
`
`STIKLONTRO
`
`STIQLOTRO
`
`6
`
`1
`
`1
`
`1
`
`2
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`1
`
`7
`
`1
`
`1
`
`1
`
`4
`
`1
`
`1
`
`5
`
`3
`
`1
`
`1
`
`0
`
`0
`
`0
`
`0
`
`24
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`6
`
`1
`
`1
`
`1
`
`27
`
`7
`
`1
`
`1
`
`1
`
`4
`
`1
`
`1
`
`5
`
`3
`
`1
`
`1
`
`Reference ID: 4073142
`
`15
`
`

`

`No.
`
`1.
`
`Appendix C: Highly Similar Names (e.g., combined POCA score is ≥70%)
`Proposed name: Steglatro
`POCA
`Orthographic and/or phonetic differences in the
`Established name:
`Score
`names sufficient to prevent confusion
`ertugliflozin
`(%)
`Dosage form: tablet
`Strength(s): 5 mg and 15 mg
`Usual Dose: 1 tablet daily
`Stelara
`
`Other prevention of failure mode expected to
`minimize the risk of confusion between these two
`names.
`The lengths of the names differ by 2 letters. Steglatro
`has a downstroke letter ‘g’ in the 4th position and a
`cross-stroke letter ‘t’ in the suffix, which is absent in
`Stelara.
`
`71
`
`The second (-gla- vs. -la-) and third syllables (–tro vs. -
`ra) sound different.
`
`Product characteristics:
`Strength: 5 mg and 15 mg vs. 45 mg/0.5 mL and 90
`mg/mL (prefilled syringe), 130 mg/26 mL (5 mg/mL)
`(single-dose vial)
`Dose: 5 mg or 15 mg (1 tablet) vs. 90 mg or 45 mg
`(subcutaneous) and 260, 390, and 520 mg (intravenous
`infusion) --- no overlap in dose
`Route of administration: oral vs. subcutaneous and
`intravenous infusion
`Dosage form: tablets vs. injection
`
`Appendix D: Moderately Similar Names (e.g., combined POCA score is ≥55% to ≤69%) with
`no overlap or numerical similarity in Strength and/or Dose
`No.
`Name
`POCA Score (%)
`1.
`Astragalus Root
`61
`2.
`***
`58
`3.
`Segluromet***
`58
`4.
`Starlix
`56
`5.
`Steroform
`56
`6.
`Stangard
`55
`7.
`Spastolate
`55
`8.
`Blister Blaster
`54
`9.
`Rose Bengal At
`54
`10.
`Tea Tree Oil
`54
`11.
`Trelstar
`54
`12.
`Trelstar La
`52
`13.
`Estrogel
`50
`14.
`Sno-Tears
`50
`15.
`Galactose
`48
`
`Reference ID: 4073142
`
`16
`
`(b) (4)
`
`

`

`No.
`16.
`17.
`18.
`
`Name
`Soothe Regular Strength
`Trelstar Depot
`Ergostat
`
`POCA Score (%)
`48
`46
`44
`
`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: Steglatro
`POCA
`Prevention of Failure Mode
`Established name:
`Score
`ertugliflozin
`(%)
`Dosage form: Tablet
`Strength(s): 5 mg and 15 mg
`Usual Dose: 1 tablet once
`daily
`Steglujan***
`
`No.
`
`1.
`
`2.
`
`3.
`
`4.
`
`***
`
`Oxtellar
`
`Salmeterol
`
`5.
`
`Testro-L.A.
`
`62
`
`60
`
`59
`
`58
`
`56
`
`In the conditions outlined below, the following
`combination of factors, are expected to minimize the
`risk of confusion between these two names
`
`The suffixes of this name pair have sufficient
`orthographic differences.
`This name appears different when scripted.
`The second and third syllables (-glu- and –jan) of this
`name sound different from Steglatro (-gla- and –tro).
`Steglujan*** is a fixed dose combination product of
`ertugliflozin and sitagliptin, available in tablets of 5
`mg/100 mg, 15 mg/100 mg,
`mg strengths. Although the strengths between the two
`products overlap, the strength of the second component
`of Steglujan***
`
`would need to be specified.
`
`
`
`The prefixes, infixes and suffixes of this name pair
`have sufficient orthographic differences.
`The first, second and third syllables (Ox-, -tel-, and –lar)
`of this name sound different from that of Steglatro.
`The prefix (Sal-), infix (-me-) and suffix (-ol) of this
`name pair have sufficient orthographic differences.
`This name has four syllables (Sal-, -me-,-te-, -rol) which
`is one more syllable than Steglatro. The first, second,
`and third syllable sound different than Ste-gla-tro.
`This root name begins with a different first letter than
`Steglatro (T vs. S). In addition, the prefix, infix, and
`suffix appear dissimilar from Steglatro when scripted.
`The root name has one less syllable than Steglatro, and
`the first syllable of this name pair sounds different.
`
`Reference ID: 4073142
`
`17
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`No.
`
`6.
`
`7.
`
`Proposed name: Steglatro
`Established name:
`ertugliflozin
`Dosage form: Tablet
`Strength(s): 5 mg an