CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`
`214120Orig1s000
`
`
`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:
`July 30, 2020
`Application Type and Number: NDA 214120
`Product Name and Strength:
`Onureg (azacitidine) tablets, 200 mg and 300 mg
`Product Type:
`Single Ingredient Product
`Rx or OTC:
`Prescription (Rx)
`Applicant/Sponsor Name:
`Celgene Corporation (Celgene)
`Panorama #:
`2020-40796300
`DMEPA Safety Evaluator:
`Ariane O. Conrad, PharmD, BCACP, CDCES
`DMEPA Team Leader:
`Hina Mehta, PharmD
`
`Reference ID: 4649214
`
`

`

`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 CONCLUSION ........................................................................................................................5
`3.1
`Comments to the Applicant/Sponsor ................................................................................5
`4 REFERENCES.........................................................................................................................6
`APPENDICES .................................................................................................................................7
`
`
`
`Reference ID: 4649214
`
`

`

`1
`
`INTRODUCTION
`
`This review evaluates the proposed proprietaiy name, Onureg, from a safety and misbranding
`perspective. The sources and methods used to evaluate the proposed proprietaiy name are
`outlined in the reference section and Appendix A respectively. Celgene submitted an external
`h" h
`.
`d d
`.
`.
`(b)(4)
`name stu ya, con ucte
`y
`w ic was rev1ewe m-ing our prev10us
`d
`d
`d b
`evaluation of this proposed proprietaiy name under IND 074618.b Of note, Celgene 's June 19,
`2020 proprietaiy name submission refers to the data submitted to their Mai·ch 3, 2020 proprietaiy
`name submission for Onureg.
`
`1.1
`
`REGULATORY HISTORY
`
`Celgene submitted the proposed proprieta1y name Onureg on September 26, 2014 under IND
`074618. DMEPA found the name to be acceptable on Mai·ch 19, 2015 under the IND.b Thus,
`Celgene submitted the name Onureg for review under NDA 214120 on March 3, 2020.
`
`On April 30, 2020, c
`gene ~ubmitted a request to with draw the proposed name Onmeg and
`41*** for review under NDA 214120. Subse uently, on June 19,
`submitted the name
`(bH
`41*** and resubmitted
`2020, Celgene submitted a request to withdraw the proposed name
`the name Onmeg for review.
`
`(bH
`
`1.2
`
`PRODUCT INFORMATION
`
`The June 19, 2020 proprietaiy name submission refers to the Mai·ch 3, 2020 proprietaiy name
`submission for product info1m ation. The following product infon nation is provided in the
`proprietaiy name and labeling submissions received on March 3, 2020, and response to
`info1mation request received July 22, 2020.
`•
`•
`•
`
`Intended Pronunciation: OWN-yew-reg
`
`Nonproprietaiy Name: azacitidine
`
`•
`•
`
`Route of Administration: oral
`
`Dosage Fon n: tablets
`
`•Request for Proprietary Name Review for azacytidine for oral administration (NDA 214 120). Sununit (NJ):
`Celgene Corporation; 2020 Mar 3. Available from: \\cdsesubl\evsprod\nda214120\000l\ml\us\onmeg.pdf.
`
`b Rutledge M . Proprietary Name Review for Onmeg (IND 074618). Silver Spring (MD). FDA, CDER, OSE,
`DMEPA (US). 2015 Mar 19. Panorama No.: 2014-36965.
`
`Reference ID 4649214
`
`1
`
`

`

` Strength: 200 mg and 300 mgc
` 300 mg once a day on Day 1 through 14 of a 28-day
` Dose and Frequency:
`treatment cycle. Dose may be adjusted to 200 mg once a day for adverse reactions.
` 14-count bottles
` How Supplied:
` Storage: store 68°F - 77°F (20°C -25°C). The proposed shelf life is
`
` months.
`
`2 RESULTS
`The following sections provide information obtained and considered in the overall evaluation of
`the proposed proprietary name, Onureg.
`
`2.1 MISBRANDING ASSESSMENT
`The Office of Prescription Drug Promotion (OPDP) determined that Onureg would not misbrand
`the proposed product per their July 9, 2020 email. The Division of Medication Error Prevention
`and Analysis (DMEPA) and the Division of Hematologic Malignancies 1 (DHM 1) concurred
`with the findings of OPDP’s assessment for Onureg.
`
`2.2 SAFETY ASSESSMENT
`The following aspects were considered in the safety evaluation of the proposed proprietary name,
`Onureg.
`
`2.2.1 United States Adopted Names (USAN) Search
`
`
`There is no USAN stem present in the proposed proprietary name1Fd.
`
`2.2.2 Components of the Proposed Proprietary Name
`Celgene indicated in their submission that the proposed proprietary name, Onureg, is “not
`derived from any one particular concept” 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 Comments from Other Review Disciplines at Initial Review
`In response to the OSE July 9, 2020 email, the Division of Hematologic Malignancies 1 (DHM
`1) did not forward any comments or concerns relating to Onureg at the initial phase of the
`review.
`
`2.2.4 FDA Name Simulation Studies
`Eighty-nine practitioners participated in DMEPA’s prescription studies for Onureg. The
`responses did not overlap with any currently marketed products nor did the responses sound or
`
`c We note that there is a change in product characteristics as Celgene proposes two tablet strengths (200 mg and 300
`mg) in the current submission. In the September 26, 2014 request for proprietary name review of Onureg, Celgene
`proposed tablet strengths of 100 mg, 150 mg, 200 mg, and 300 mg.
`d USAN stem search conducted on June 22, 2020.
`
`Reference ID: 4649214
`
`2
`
`(b) (4)
`
`(b)
`(4)
`
`(b) (4)
`
`

`

`look similar to any currently marketed products or any products in the pipeline. Appendix B
`contains the results from the prescription simulation studies.
`
`2.2.5 Phonetic and Orthographic Computer Analysis (POCA) Search Results
`Our POCA searche identified 52 names with the combined score of ≥55% or individual
`orthographic or phonetic score of ≥70%. We had identified and evaluated some of the names in
`our previous proprietary name review (OSE Review #2014-36965). 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. Of note, we considered the change from four tablet strengths (100 mg,
`150 mg, 200 mg, and 300 mg) to two tablet strengths (200 mg and 300 mg) and we agree with
`the findings from our previous review for the names evaluated previously.
`We identified 23 names not previously analyzed. These names are included in Table 1 below.
`
`2.2.6 Names Retrieved for Review Organized by Name Pair Similarity
`Table 1 lists the 23 names retrieved from our POCA search and these name pairs are organized
`as highly similar, moderately similar or low similarity for further evaluation.
`
`Table 1. Names Retrieved for Review Organized by Name Pair Similarity
`Similarity Category
`Number of Names
`Highly similar name pair:
`0
`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%
`
`22
`
`1
`
`2.2.7 Safety Analysis of Names with Potential Orthographic, Spelling, and Phonetic
`Similarities
`Our analysis of the 23 names contained in Table 1 determined none of the names will pose a risk
`for confusion with Onureg as described in Appendices C through H.
`
`2.2.8 Discussion of Dual Proprietary Name
`Celgene currently markets Vidaza (azacitidine for injection) which is indicated for the treatment
`of multiple French-American-British (FAB) myelodysplastic syndrome subtypes (NDA 050794).
`Celgene proposes to introduce a tablet dosage form of azacitidine under the proprietary name
`Onureg. Onureg will be indicated as maintenance therapy for patients with acute myeloid
`leukemia (AML). Table 2 provides relevant product information for Onureg and Vidaza.
`
`e POCA search conducted on June 22, 2020 in version 4.3.
`
`Reference ID: 4649214
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`3
`
`

`

`Table 2. Comparison of Onureg and Vidaza
`Product Name
`Onureg (NDA 214120)
`Initial Approval Date
`n/a
`Active Ingredient
`Indication
`
`Route of Administration
`
`Oral
`
`Dosage Form
`Strength
`Dose and Frequency
`
`Tablets
`200 mg and 300 mg
` 300 mg orally
`once daily on Day 1 through
`Day 14 of repeated 28-day
`treatment cycles
`
`Vidazaf (NDA 050794)
`May 19, 2004
`azacitidine
`Treatment of patients with the
`following FAB
`myelodysplastic syndrome
`(MDS) subtypes:
` Refractory anemia (RA)
` Refractory anemia with
`ringed sideroblasts
`(RARS) (if accompanied
`by neutropenia or
`thrombocytopenia or
`requiring transfusions)
` Refractory anemia with
`excess blasts (RAEB)
` Refractory anemia with
`excess blasts in
`transformation (RAEB-T)
` Chronic myelomonocytic
`leukemia (CMMoL)
`Subcutaneous injection or
`intravenous infusion
`Lyophilized powder
`100 mg per vial
`Starting dose for the first
`treatment cycle is 75 mg/m2,
`subcutaneously or
`intravenously, daily for 7
`days of a 28-day cycle
`Repeat cycles every 4 weeks
`The dose may be increased to
`100 mg/m2 if necessary
`1 single-dose vial per carton
`
`How Supplied
`
`bottles
`
` 14-count
`
`f Vidaza [Prescribing Information]. Drugs@FDA. U.S. Food and Drug Administration. 2020 Mar. Available from:
`https://www.accessdata.fda.gov/drugsatfda docs/label/2020/050794s032lbl.pdf.
`
`Reference ID: 4649214
`
`4
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`We have evaluated the risks associated with this naming strategy and do not object to the use of a
`dual proprietary name in this case.
`
`2.2.9 Communication of DMEPA’s Analysis at Midpoint of Review
`DMEPA communicated our findings to the Division of Hematologic Malignancies 1 (DHM 1)
`via email on July 28, 2020. At that time we also requested additional information or concerns
`that could inform our review. Per email correspondence from the Division of Hematologic
`Malignancies 1 (DHM 1) on July 29, 2020, they stated no additional concerns with the proposed
`proprietary name, Onureg.
`
`3 CONCLUSION
`The proposed proprietary name, Onureg, is acceptable.
`If you have any questions or need clarifications, please contact Neil Vora, OSE project manager,
`at 240-402-4845.
`
`COMMENTS TO CELGENE CORPORATION
`3.1
`We have completed our review of the proposed proprietary name, Onureg, and have concluded
`that this name is acceptable.
`If any of the proposed product characteristics as stated in your submission, received on June 19,
`2020, are altered prior to approval of the marketing application, the name must be resubmitted
`for review.
`
`Reference ID: 4649214
`
`5
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`

`

`4
`
`REFERENCES
`
`1. USAN Stems (https://www.ama-assn.org/about/united-states-adopted-names-approved-stems)
`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.
`
`Reference ID: 4649214
`
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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
`g
`
`g National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
`
`Reference ID: 4649214
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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.
`
`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%.
`
`Reference ID: 4649214
`
`8
`
`

`

`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 names F
`h. 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.,
`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.
`
`h 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: 4649214
`
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`

`

`c. FDA Prescription Simulation Studies: DMEPA staff also conducts a prescription
`simulation studies using FDA health care professionals.
`Four 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, verbal pronunciation of the drug name or
`during computerized provider order entry. 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 vulnerability of the
`proposed name to be misinterpreted by healthcare practitioners during written, verbal, or
`electronic prescribing.
`In order to evaluate the potential for misinterpretation of the proposed proprietary name
`during written, verbal, or electronic prescribing of the name, written inpatient medication
`orders, written outpatient prescriptions, verbal orders, and electronic orders are simulated,
`each consisting of a combination of marketed and unapproved drug products, including
`the proposed name.
`
`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.
`
`Reference ID: 4649214
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`

`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?
`Y/N Do the suffixes of the names 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?
`
`Reference ID: 4649214
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`

`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.
`
`Reference ID: 4649214
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`12
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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%).
`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: 4649214
`
`13
`
`

`

`Appendix B: Prescription Simulation Samples and Results
`Figure 1. Onureg Study (Conducted on April 10, 2020)
`
`Handwritten Medication Order/Prescription
`
`Medication Order:
`
`Outpatient Prescription:
`
`Verbal
`Prescription
`Onureg 300 mg
`1 tablet orally
`daily
`Dispense # 14
`
`CPOE Study Sample (displayed as sans-serif, 12-point, bold font)
`Onureg
`
`Reference ID: 4649214
`
`14
`
`

`

`FDA Prescription Simulation Responses (Aggregate Report)
`
`Reference ID: 4649214
`
`15
`
`

`

`Appendix C: Highly Similar Names (e.g., combined POCA score is ≥70%) – N/A
`
`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 (%)
`61
`68
`64
`
`Nouress
`Nurtec***
`***
`
`1.
`2.
`3.
`
`Appendix E: Moderately Similar Names (e.g., combined POCA score is ≥55% to ≤69%) with
`overlap or numerical similarity in Strength and/or Dose – N/A
`
`Appendix F: Low Similarity Names (e.g., combined POCA score is ≤54%)
`No.
`Name
`POCA
`Score (%)
`44
`
`Gordons Urea
`
`4.
`
`Appendix G: Names not likely to be confused or not used in usual practice settings for the
`reasons described.
`No.
`Name
`
`Failure preventions
`
`5.
`
`6.
`
`7.
`
`8.
`
`9.
`
`Endure 100
`
`Endure 200
`
`Endure 250
`
`Endure 300
`
`Endure 450
`
`POCA
`Score
`(%)
`56
`
`56
`
`56
`
`56
`
`56
`
`Name identified in RxNorm database. Unable to
`find product characteristics in commonly used drug
`databases.
`Name identified in RxNorm database. Unable to
`find product characteristics in commonly used drug
`databases.
`Name identified in RxNorm database. Unable to
`find product characteristics in commonly used drug
`databases.
`Name identified in RxNorm database. Unable to
`find product characteristics in commonly used drug
`databases.
`Name identified in RxNorm database. Unable to
`find product characteristics in commonly used drug
`databases.
`
`Reference ID: 4649214
`
`16
`
`(b) (4)
`
`

`

`No.
`
`Name
`
`10.
`
`I
`
`(b) (4I * * *
`
`POCA
`Score
`(% )
`60
`
`Failure preventions
`
`•><~
`
`11.
`
`Phenurone
`
`12.
`
`Puregon
`
`57
`
`61
`
`I
`Brand discontinued with no generic equivalents
`available. NDA 007707 withdrawn FR effective
`6/4/2004.
`International product marketed in multiple
`counti·ies, including Canada and Gennany.
`
`Appendix H: Names not likely to be confused due to absence of atti·ibutes that are known to
`cause name confusion.i.
`No.
`Name
`
`Allergan
`13.
`Allergan 50
`14.
`Anturane
`15.
`Enduron
`16.
`17. Neuraceq
`18. Neuromed
`(b) (41 * * *
`I
`19.
`Nu-Iron
`20.
`Nu-Iron 150
`21.
`I
`(b)(4~ ***
`22.
`Zonegran
`23.
`
`POCA
`Score(%)
`56
`56
`56
`61
`58
`61
`56
`60
`60
`58
`57
`
`i Shah, M, Merchant, L, Chan, I, and Taylor, K. Characteristics That May Help in the Identification of Potentially
`Confusing Proprietary Drng Names. Therapeutic Innovation & Regulatory Science, September 2016
`
`Reference ID 4649214
`
`17
`
`

`

`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`ARIANE O CONRAD
`07/30/2020 12:19:51 PM
`
`HINA S MEHTA
`07/31/2020 11:05:10 AM
`
`Reference ID: 4649214
`
`