CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`208700Orig1s000
`
`PROPRIETARY NAME REVIEW(S)
`
`
`
`
`
`

`

`PROPRIETARY NAME REVIEW
`Division of Medication Error Prevention and Analysis (DMEPA)
`Office of Medication Error Prevention and Risk Management (OMEPRM)
`Office of Surveillance and Epidemiology (OSE)
`Center for Drug Evaluation and Research (CDER)
`
`*** This document contains proprietary information that cannot be released to the
`public***
`
`Date of This Review:
`January 8, 2018
`Application Type and Number: NDA 208700
`Product Name and Strength:
`Lutathera (lutetium Lu 177 dotatate) Injection,
`370 MBq/mL
`Single Ingredient Product
`Rx
`Advanced Accelerator Applications USA Inc.
`2017-18841079
`Janine Stewart, PharmD
`Chi-Ming (Alice) Tu, PharmD
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Panorama #:
`DMEPA Safety Evaluator:
`DMEPA Team Leader:
`
`Reference ID: 4204570
`
`

`

`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..........................................................................................................4
`3.1
`Comments to the Applicant...................................................................................4
`4 REFERENCES.............................................................................................................5
`APPENDICES .....................................................................................................................6
`
`
`
`Reference ID: 4204570
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`

`

`INTRODUCTION
`1
`This review evaluates the proposed proprietary name, Lutathera, 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.
`
`REGULATORY HISTORY
`1.1
`The Applicant previously submitted the proposed proprietary name, Lutathera on November 9,
`2015 under IND 077219 and on April 28, 2016 under NDA 208700. The Division of Medication
`Error Prevention and Analysis (DMEPA) found the name, Lutathera, acceptable on April 5, 2016
`and again on May 26, 2016.a,b However, the Division of Oncology Products 2 (DOP2) issued a
`Complete Response (CR) for the application on December 19, 2016.
`For the class 2 resubmission, the Applicant submitted the NDA on July 26, 2017, and submitted
`the proposed proprietary name, Lutathera, for review on November 8, 2017.
`
`PRODUCT INFORMATION
`1.2
`The following product information is provided in the November 8, 2017 proprietary name
`submission.
`Intended Pronunciation: Lou-Ta-Ther-a
`
` Active Ingredient: Lutetium Lu 177 dotatate
`Indication of Use: Treatment of somatostatin receptor positive gastroenteropancreatic
`
`neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut
`neuroendocrine tumors in adults.
` Route of Administration: Intravenous
` Dosage Form: Injection
` Strength: 370 MBq/mL
` Dose and Frequency: A cumulative dose of 29.6 GBq (maximum dose) divided into
`four- 30 minute intravenous infusions of 7.4 GBq at 8
`week intervals
` to accommodate resolving toxicity. The product is administered with a
`concomitant infusion of an amino acid solution containing arginine and lysine.
` How Supplied: Ready-to-use, single-dose,
` mL vials containing 7.4 GBq of
`Lutathera. The product is shipped to the hospital (radiopharmacy) or nuclear medicine
`physician
`
`
`
`a Stewart, J. Proprietary Name Review for Lutathera IND 077219. Silver Spring (MD): FDA, CDER, OSE, DMEPA
`(US); 2016 Apr 05. RCM No.: 2015-1947595.
`
`b Stewart, J. Proprietary Name Review for Lutathera NDA 208700. Silver Spring (MD): FDA, CDER, OSE,
`DMEPA (US); 2016 May 26. RCM No.: 2016-7757226.
`
`Reference ID: 4204570
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`1
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`(b) (4)
`
`(b) (4)
`
`(b)
`(4)
`
`(b) (4)
`
`

`

`(b) (4)
`
`0”“) Store in its original packaging for
`0 Storage: Store below
`radioprotection purposes. Vial radioactivity must be verified before infilsion. Shelf life:
`Maximum 72 hours
`a”).
`
`The product must be stored according to national regulations concerning radioactive
`products and will be labeled with the cautionary statement.
`0 Container and Closure Systems: A single dose (momL vial, colorless Type I glass
`enclosed with a rubber stopper and sealed by an aluminum crimp. The vial is enclosed
`within a lead container with 12 mm shielding (inner dimensions: 33.4 x 69 mm [dia X H],
`outer dimensions: 57 x 93.7 mm [dia x H]). The lead container is green
`(mo
`The lead container is sealed with
`(m4) packaging tape and every container is also
`packed in :2; bags. These are leak proof, airtight and tamper evident. The bags are tested
`at 33 kPa.
`
`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. The Division of Medication Error Prevention and Analysis
`(DMEPA) and the Division of Oncology Products 2 ODOPZ) 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 name“.
`
`2.2.2 Components ofthe Proposed Proprietary Name
`
`The Applicant did not provide a derivation or intended meaning for the proposed name in the
`cunent submission. However, the Applicant previously indicated in their request for proprietary
`name submission under the IND that the proposed name, Lutathera, is derived from Lutetium.
`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.
`
`‘ USAN stem search conducted on (November 17, 2017).
`
`Reference ID: 4204570
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`2.2.3 Comments from Other Review Disciplines at Initial Review
`In response to the OSE, November 30, 2017 e-mail, the Division of Oncology Products 2
`(DOP2) did not forward any comments or concerns relating to the proposed proprietary name at
`the initial phase of the review.
`
`2.2.4 FDA Name Simulation Studies
`Ninety-three 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.
`
`2.2.5 Phonetic and Orthographic Computer Analysis (POCA) Search Results
`Our POCA searchd identified 142 names with a combined phonetic and orthographic score of
`≥55% or an individual phonetic or orthographic score ≥70%. We had identified and evaluated
`some of the names in our previous proprietary name review. 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, we identified
`77 names not previously analyzed. These names are included in Table 1 below.
`
`2.2.6 Names with Strength Overlap and Potential Orthographic, Spelling, and Phonetic
`Similarities
`
`The proposed product, Lutathera will be available in 370 MBq/mL strength(s). Since this is
`not a typical strength that is commonly marketed, we searched the Electronic Drug
`Registration and Listing System (eDRLS) database to identify names with strength overlap.
`We did not identify names with strength overlap and potential orthographic, spelling, and
`phonetic similarities with Lutathera. Names identified in the eDRLS database not likely to be
`confused due to notable spelling, orthographic and phonetic differences are listed in Appendix
`I.
`
`d POCA search conducted on December 14, 2017 in version 4.2.
`
`Reference ID: 4204570
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`2.2.7 Names Retrieved for Review Organized by Name Pair Similarity
`Table 1 lists the number of names retrieved from our POCA search. These name pairs are
`organized as highly similar, moderately similar or low similarity for further evaluation.
`
`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
`
`46
`
`30
`
`2.2.8 Safety Analysis of Names with Potential Orthographic, Spelling, and Phonetic
`Similarities
`Our analysis of the 77 names contained in Table 1 determined none of the names will pose a risk
`for confusion as described in Appendices C through H.
`
`2.2.9 Communication of DMEPA’s Analysis at Midpoint of Review
`DMEPA communicated our findings to the Division of Oncology Products 2 (DOP2) via e-mail
`on January 3, 2018. At that time, we also requested additional information or concerns that
`could inform our review. Per e-mail correspondence from the DOP2 on January 4, 2018, they
`stated no additional concerns with the proposed proprietary name, Lutathera.
`
`3 CONCLUSIONS
`The proposed proprietary name is acceptable.
`If you have any questions or need clarifications, please contact Latonia Ford, OSE project
`manager, at 301-796-4910.
`
`COMMENTS TO THE APPLICANT
`3.1
`We have completed our review of the proposed proprietary name, Lutathera, and have concluded
`that this name is acceptable.
`If any of the proposed product characteristics as stated in your November 8, 20017 submission
`are altered prior to approval of the marketing application, the name must be resubmitted for
`review.
`
`Reference ID: 4204570
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`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: 4204570
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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. e
`
`e National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
`
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`*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: 4204570
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`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: 4204570
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`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: 4204570
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`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
`upstroke/downstroke letters present
`in the names?
`
`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?
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`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?
`
`Y/N Across a range of dialects, are
`the names consistently
`pronounced differently?
`
`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
`
`Reference ID: 4204570
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`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.
`Orthographic Checklist (Y/N to each
`Phonetic Checklist (Y/N to each
`question)
`question)
` Do the names begin with different
` Do the names have
`first letters?
`different number of
`syllables?
`Note that even when names begin with
`different first letters, certain letters may be
` Do the names have
`confused with each other when scripted.
`different syllabic stresses?
` Are the lengths of the names
` Do the syllables have
`dissimilar* when scripted?
`different phonologic
`*FDA considers the length of names
`processes, such vowel
`different if the names differ by two or
`reduction, assimilation, or
`more letters.
`deletion?
` Considering variations in scripting
` Across a range of dialects,
`of some letters (such as z and f), is
`are the names consistently
`there a different number or
`pronounced differently?
`placement of upstroke/downstroke
`letters present in the names?
`Is there different number or
`placement of cross-stroke or dotted
`letters present in the names?
` Do the infixes of the name appear
`dissimilar when scripted?
` Do the suffixes of the names appear
`dissimilar when scripted?
`
`
`
`Table 5: Low Similarity Name Pair Checklist (i.e., combined score is ≤54%).
`Names with low similarity are generally acceptable unless there are data to suggest that
`the name might be vulnerable to confusion (e.g., prescription simulation study suggests
`that the name is likely to be misinterpreted as a marketed product). In these instances,
`we would reassign a low similarity name to the moderate similarity category and
`review according to the moderately similar name pair checklist.
`
`Reference ID: 4204570
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`Appendix B: Prescription Simulation Samples and Results
`Figure 1. Lutathera Study (Conducted on November 9, 2017)
`
`Handwritten Medication Order/Prescription
`
`Medication Order:
`
`Outpatient Prescription:
`
`Verbal
`Prescription
`Lutathera
`7.4 GBq IV once
`Ship to clinic
`
`Reference ID: 4204570
`
`13
`
`

`

`FDA Prescription Simulation Responses (Aggregate l Rx Studies Report)
`
`Study Name: Lutathera
`
`As of Date 12/28/2017
`
`298 People Received Study
`
`93 People Responded
`
`Study Name: Lutathera
`Total
`
`29
`
`28
`
`36
`
`INTERPRETATION
`
`OUTPATIENT
`
`G LUTATH ERA
`
`LEUTATH E RAY
`
`LUTOVE RA HwHOHNHHaooomHHH
`OOOOOOOOOHOO
`OOOHOOOOOONI—I
`HwHHHNHHmHNH
`
`LUCETE RA
`
`LUTATHERA
`
`LUTATHERN
`
`LUTATHI RA
`
`LUTATJ ERA
`
`LUTAVERA
`
`LUTAZE RA
`
`LUTEFERA
`
`LUTETHERA
`
`LUTEVERA
`
`LUTHATH ERA
`
`LUTICE RA
`
`LUTITH ERA
`
`Reference ID: 4204570
`
`14
`
`

`

`No.
`
`1.
`
`Appendix C: Highly Similar Names (e.g., combined POCA score is ≥70%)
`Proposed name: Lutathera
`POCA
`Orthographic and/or phonetic differences in the
`Established name: lutetium
`Score
`names sufficient to prevent confusion
`(%)
`Lu 177 dotatate
`Dosage form: Injection
`Strength(s): 370 MBq/mL
`Usual Dose: 7.4 GBq
`intravenously every 8 weeks
`for 4 infusions
`Lutathera
`
`Other prevention of failure mode expected to
`minimize the risk of confusion between these two
`names.
`
`100
`
`The subject of this review.
`Previously found acceptable for this NDA 208700.
`
`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 (%)
`58
`67
`56
`56
`67
`58
`68
`66
`55
`60
`61
`55
`60
`
`***
`
`Repatha
`Ultra Tears
`Ultram Er
`Ultravate
`
`***
`
`Aftera
`
`***
`
`Lactrase
`Lesinurad
`
`***
`Lumacaftor
`Lunestar
`
`2.
`3.
`4.
`5.
`6.
`7.
`8.
`9.
`10.
`11.
`12.
`13.
`14.
`
`Reference ID: 4204570
`
`15
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(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: Lutathera
`POCA
`Prevention of Failure Mode
`Score
`Established name: lutetium
`(%)
`Lu 177 dotatate
`Dosage form: Injection
`Strength(s): 370 MBq/mL
`Usual Dose: 7.4 GBq
`intravenously every 8 weeks
`for 4 infusions
`Artemether
`
`In the conditions outlined below, the following
`combination of factors, are expected to minimize the
`risk of confusion between these two names
`
`This name pair has sufficient orthographic and phonetic
`differences.
`This name pair has sufficient orthographic and phonetic
`differences.
`
`No.
`
`15.
`
`16.
`
`Leustat
`
`57
`
`55
`
`Appendix F: Low Similarity Names (e.g., combined POCA score is ≤54%)
`No.
`Name
`POCA
`Score (%)
`46
`48
`51
`51
`48
`44
`42
`53
`50
`52
`52
`52
`52
`46
`52
`52
`52
`52
`52
`52
`50
`46
`50
`51
`49
`51
`
`Ah-Chew Ultra
`Caltrate
`Durathate
`Durathate 200
`Ethyl Butyrate
`Flurate
`Gum Talha Extract
`Heather
`Laurate
`Laureth-10
`Laureth-11
`Laureth-12
`Laureth-2
`Laureth-2 Sulfate
`Laureth-23
`Laureth-3
`Laureth-30
`Laureth-4
`Laureth-7
`Laureth-9
`Norlutate
`Quarter Mate
`Tartrate
`T-Athlete
`Thera-D
`Theraflu
`
`17.
`18.
`19.
`20.
`21.
`22.
`23.
`24.
`25.
`26.
`27.
`28.
`29.
`30.
`31.
`32.
`33.
`34.
`35.
`36.
`37.
`38.
`39.
`40.
`41.
`42.
`
`Reference ID: 4204570
`
`16
`
`

`

`Name
`
`No.
`
`43.
`44.
`45.
`46.
`
`Thera-Flur-N
`Thera-Sal
`Ultralente
`Ultratag
`
`POCA
`Score (%)
`48
`52
`50
`54
`
`Appendix G: Names not likely to be confused or not used in usual practice settings for the
`reasons described.
`No.
`Name
`
`Failure preventions
`
`Name identified in Rx Norm Database. Unable to
`find product characteristics in commonly used drug
`databases.
`International product name.
`Name identified in RxNorm Database.
`Unable to find product characteristics in commonly
`used drug databases.
`Name identified in RxNorm Database.
`Glutarate is not a drug. It is an organic compoun