CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`022063Orig1s000
`
`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:
`April 13, 2017
`Application Type and Number: NDA 022063
`Product Name and Strength:
`Mydayis (mixed salts of a single-entity amphetamine
`product) extended-release capsules
`12.5 mg, 25 mg, 37.5 mg, and 50 mg
`Single Ingredient Product
`Rx
`Shire Development LLC
`2017-12614118
`Loretta Holmes, BSN, PharmD
`Lolita White, PharmD
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Team Leader:
`
`Reference ID: 4083609
`
`

`

`1
`
`2
`
`Contents
`INTRODUCTION ....................................................................................................................1
`1.1
`Regulatory History ............................................................................................................1
`1.2
`Product Information ..........................................................................................................1
`RESULTS.................................................................................................................................1
`2.1 Misbranding Assessment ..................................................................................................2
`2.2
`Safety Assessment.............................................................................................................2
`CONCLUSIONS ......................................................................................................................5
`3.1
`Comments to the Applicant...............................................................................................5
`REFERENCES .........................................................................................................................6
`4
`APPENDICES .................................................................................................................................7
`
`3
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`Reference ID: 4083609
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`

`

`INTRODUCTION
`1
`This review evaluates the proposed proprietary name, Mydayis, 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 resubmitted the 2014 external
`name study, conducted by
`, for this product.
`
`REGULATORY HISTORY
`1.1
` on July 21, 2006
`The Applicant initially submitted the proposed proprietary name
`for NDA 022063. DMEPA found the name conditionally acceptable in OSE Review 2007-21,
`dated May 2, 2007. The FDA issued an Approvable Letter to the NDA on May 18, 2007.
`The Applicant withdrew the name
` on December 17, 2014 and submitted the
`proposed name, Mydayis, on December 18, 2014 for our review. The name Mydayis was found
`conditionally acceptable in a memorandum appended to OSE Review 2014-46036, dated June 3,
`2015. The Applicant submitted a Class 2 Resubmission of the NDA on December 20, 2016.
`Subsequently, the Applicant resubmitted the proposed name Mydayis for review on January 17,
`2017.
`
`PRODUCT INFORMATION
`1.2
`The following product information is provided in the January 17, 2017 proprietary name
`submission.
`Intended Pronunciation: my-DAY-is
`
` Active Ingredient: mixed salts of a single-entity amphetamine product
`Indication of Use: Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
`
` Route of Administration: Oral
` Dosage Form: Extended-release capsule
` Strengths: 12.5 mg, 25 mg, 37.5 mg and 50 mg
` Dose and Frequency: The recommended starting dose is 12.5 mg once daily in the
`morning. Dosage may be adjusted in increments of 12.5 mg no sooner than weekly to a
`maximum dose of 50 mg once daily.
` How Supplied: 100-count bottles
` Storage: Store at room temperature, 20ºC to 25ºC (68ºF to 77ºF). Excursions permitted
`between 15-30º C (59-86º F)
` Container and Closure Systems: HDPE bottle
`
`.
`
`2 RESULTS
`The following sections provide information obtained and considered in the overall evaluation of
`the proposed proprietary name.
`
`Reference ID: 4083609
`
`1
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`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
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`

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`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 Division of Psychiatry
`Products (DPP) 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.a
`
`2.2.2 Components of the Proposed Proprietary Name
`The Applicant indicated in their submission that the proposed name, Mydayis, is not derived
`from any one particular concept. This proprietary name is comprised of a single word that does
`not contain any components (i.e. a modifier, route of administration, dosage form, etc.) that are
`misleading or can contribute to medication error.
`
`2.2.3 FDA Name Simulation Studies
`Eighty-five (85) 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, February 7, 2017 e-mail, the Division of Psychiatry Products (DPP) did
`not forward any comments or concerns relating to the proposed proprietary name at the initial
`phase of the review.
`
`2.2.5 Safety Assessment of the Proposed product Mydayis and risk of confusion with
`currently marketed Adderall XR
`The proposed product Mydayis contains the exact combination of mixed amphetamine salts
`found in the currently marketed Adderall XR, which is also a Shire product. We identified
`similarities that may lead to confusion or risk of prescribing errors between the two products if
`not adequately mitigated. Both products have the same established name and dosage form
`(mixed salts of a single-entity amphetamine product extended release capsule). Additionally,
`both products overlap in frequency of administration (once daily in the morning) and overlap in
`one strength (25 mg). Although, the products have similarities, they also have differences. One
`difference is in their pK profiles, specifically, in the duration of action. Mydayis has a duration
`of action of 16 hours whereas Adderall XR has a duration of action of 10 to 12 hours. We are
`concerned that health care practitioners and patients will not be aware that Mydayis is different
`
`a USAN stem search conducted on March 10, 2017.
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`from Adderall XR because the products contain the same active ingredients and have an
`overlapping strength and frequency of administration.
`Modifiers are sometimes useful to convey certain product characteristics or to distinguish
`different product formulations within the same product line. Therefore, we evaluated whether
`the addition of a modifier to the name, Mydayis, to convey that the product is an
`extended-release dosage form will help to decrease confusion with Adderall XR. The modifiers
`XR and ER, for example, are known modifiers used to indicate that a product is an extended
`release dosage form. Adderall is a root name for the Adderall product line and the modifier XR is
`used to further distinguish the Adderall immediate release formulation from the Adderall XR
`extended release formulation. In contrast, the Mydayis product is not a product line extension of
`a currently existing “Mydayis” immediate release product. Thus, a modifier is not necessary to
`distinguish extended release and immediate release formulations of Mydayis. Furthermore,
`adding a modifier to the name Mydayis may not help to differentiate it from Adderall XR. While
`a modifier may help to convey that both products are extended release formulations, the modifier
`will not convey the differences in the pK profiles.
`We also considered the risk of confusion that may occur when the products are prescribed by
`their established names only, particularly if a generic equivalent becomes available. One method
`by which such confusion has been minimized is for the labels of the generic product to specify
`the frequency of administration of the drug, the proprietary name modifier used in the
`proprietary name of the reference listed drug, or both. For example, the label of a generic
`product might prominently state “once daily”, “twice daily”, ER, or XR based in the frequency
`of administration and proprietary name modifier of the referenced drug. However, if the drug
`Mydayis is approved and generics are developed later, the frequency of administration would not
`be a useful means to differentiate the generic formulations of Adderall XR and Mydayis.
`Additionally, the use of the reference listed drug’s proprietary name modifier on the generic labels
`and labeling has limited long-term usefulness as more generic products with the same established
`names and dosage forms come to market with differing pK profiles.b We also recognize that
`confusion may occur prior to the development of a generic formulation of
`Mydayis because the established name of the product may be used in prescribing regardless of
`whether or not a generic formulation is available.
`In our initial review of this product in 2007c, we identified the potential for confusion with
`Adderall XR, and recommended that, if approved; Shire should develop and implement a plan to
`educate healthcare providers and consumers about the differences between this product and their
`Adderall products (Adderall and Adderall XR). Additionally, we recommended that Shire
`ensure this product does not have labels and labeling that overlap with the Adderall XR color
`scheme.
`
`b The OPQ reviewer notified the Office of Generic Drugs (OGD) of the risk for confusion between generic
`formulations with the same established name and differing pK profiles in an email correspondence dated March 29-
`31, 2017, to determine the label and labeling strategies currently employed by OGD that may assist in differentiation
`of similarly situated generic products.
`
`c Wisniewski, L. Proprietary Name and Labels and Labeling Review for
`FDA, CDER, OSE, DMEPA (US); 2007 May 02. RCM No.: 2017-21.
`
` NDA 022063. Silver Spring (MD):
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`Reference ID: 4083609
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`(b) (4)
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`Shire proposes alternatives to a modifier to mitigate risk of confusion. In Shire’s Class 2
`resubmission, they include a risk management plan (RMP). The RMP includes labeling
`interventions and educating healthcare providers and consumers about the differences between
`Mydayis and the Adderall products. Our review of the labeling interventions and educational
`plan is in progress and will be reported under separate cover. d The acceptability of the RMP to
`prevent potential confusion with the products will be a review matter.
`
`2.2.6 Phonetic and Orthographic Computer Analysis (POCA) Search Results
`Our POCA search identified 45 names with the combined score of ≥55%. We had identified and
`evaluated 69 names in our previous proprietary name review of Mydayis. We re-evaluated the
`previously identified names of concern considering any lessons learned from recent
`postmarketing 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 16 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. 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
`0
`
`14
`
`2
`
`2.2.7 Names with Potential Orthographic, Spelling, and Phonetic Similarities that overlap in
`strength
`The proposed product, Mydayis, will be available in a 37.5 mg strength. Since this is not a typical
`strength that is commonly marketed, we searched the Electronic Drug Registration and Listing
`System (eDRLS) database to identify any names with an overlap in strength and potential
`orthographic, spelling, and phonetic similarities with Mydayis that were not identified in POCA.
`
`Table 1A. eDRLS Search Resultse
`No look-alike or sound-alike names were identified
`
`POCA Score (%)
`
`d OSE Review #2017-125.
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`Reference ID: 4083609
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`2.2.8 Safety Analysis of Names with Potential Orthographic, Spelling, and Phonetic
`Similarities
`Our analysis of the 16 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 Psychiatry Products (DPP) via e-mail on
`April 10, 2017. At that time, we also requested additional information or concerns that could
`inform our review. Per e-mail correspondence from the DPP on April 11, 2017, they stated no
`additional concerns with the proposed proprietary name, Mydayis.
`
`3 CONCLUSIONS
`The proposed proprietary name is acceptable.
`If you have any questions or need clarifications, please contact Alycia Anderson, OSE Project
`Manager, at 240-402-4270.
`
`COMMENTS TO THE APPLICANT
`3.1
`We have completed our review of the proposed proprietary name, Mydayis, and have concluded
`that this name is acceptable.
`If any of the proposed product characteristics as stated in your January 17, 2017 submission are
`altered prior to approval of the marketing application, the name must be resubmitted for review.
`
`e eDRLS search conducted on March 13, 2017.
`
`Reference ID: 4083609
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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.
`3. Drugs@FDA
`Drugs@FDA is an FDA Web site that contains most of the drug products approved in the United States
`since 1939. The majority of labels, approval letters, reviews, and other information are available for drug
`products approved from 1998 to the present. Drugs@FDA contains official information about FDA-
`approved brand name and generic drugs; therapeutic biological products, prescription and over-the-
`counter human drugs; and discontinued drugs (see Drugs @ FDA Glossary of Terms, available at
`http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm#ther biological).
`
`4. RxNorm
`
`RxNorm contains the names of prescription and many OTC drugs available in the United States. RxNorm
`includes generic and branded:
`
` Clinical drugs – pharmaceutical products given to (or taken by) a patient with therapeutic or
`diagnostic intent
` Drug packs – packs that contain multiple drugs, or drugs designed to be administered in a
`specified sequence
`
`Radiopharmaceuticals, contrast media, food, dietary supplements, and medical devices, such as bandages
`and crutches, are all out of scope for RxNorm
`(http://www.nlm.nih.gov/research/umls/rxnorm/overview.html#).
`
`5. Division of Medication Errors Prevention and Analysis proprietary name consultation requests
`This is a list of proposed and pending names that is generated by the Division of Medication Error
`Prevention and Analysis from the Access database/tracking system.
`
`6. Electronic Drug Registration and Listing System (eDRLS) database
`The electronic Drug Registration and Listing System (eDRLS) was established to supports the FDA’s
`Center for Drug Evaluation and Research (CDER) goal to establish a common Structured Product
`Labeling (SPL) repository for all facilities that manufacture regulated drugs. The system is a reliable, up-
`to-date inventory of FDA-regulated, drugs and establishments that produce drugs and their associated
`information.
`
`Reference ID: 4083609
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`APPENDICES
`Appendix A
`FDA’s Proprietary Name Risk Assessment evaluates proposed proprietary names for
`misbranding and safety concerns.
`1. Misbranding Assessment: For prescription drug products, OPDP assesses the name for
`misbranding concerns. . For over-the-counter (OTC) drug products, the misbranding
`assessment of the proposed name is conducted by DNDP. OPDP or DNDP evaluates
`proposed proprietary names to determine if the name is false or misleading, such as by
`making misrepresentations with respect to safety or efficacy. For example, a fanciful
`proprietary name may misbrand a product by suggesting that it has some unique
`effectiveness or composition when it does not (21 CFR 201.10(c)(3)). OPDP or DNDP
`provides their opinion to DMEPA for consideration in the overall acceptability of the
`proposed proprietary name.
`2. Safety Assessment: The safety assessment is conducted by DMEPA, and includes the
`following:
`a. Preliminary Assessment: We consider inclusion of USAN stems or other characteristics
`that when incorporated into a proprietary name may cause or contribute to medication
`errors (i.e., dosing interval, dosage form/route of administration, medical or product name
`abbreviations, names that include or suggest the composition of the drug product, etc.)
`See prescreening checklist below in Table 2*. DMEPA defines a medication error as any
`preventable event that may cause or lead to inappropriate medication use or patient harm
`while the medication is in the control of the health care professional, patient, or
`consumer. f
`*Table 2- Prescreening Checklist for Proposed Proprietary Name
`
`Answer the questions in the checklist below. Affirmative answers
`to any of these questions indicate a potential area of concern that
`should be carefully evaluated as described in this guidance.
`Y/N Is the proposed name obviously similar in spelling and pronunciation to other
`names?
`Proprietary names should not be similar in spelling or pronunciation to proprietary
`names, established names, or ingredients of other products.
`Y/N Are there 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)).
`
`f National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
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`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%.
`Using the criteria outlined in the checklist (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.
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` 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 namesg. 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.
`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.
`
`g 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: 4083609
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`The voice mail messages are then sent to a random sample of the participating health
`professionals for their interpretations and review. After receiving either the written or
`verbal prescription orders, the participants record their interpretations of the orders which
`are recorded electronically.
`d. Comments from Other Review Disciplines: DMEPA requests the Office of New Drugs
`(OND) and/or Office of Generic Drugs (OGD), ONDQA or OBP for their comments or
`concerns with the proposed proprietary name, ask for any clinical issues that may impact
`the DMEPA review during the initial phase of the name review. Additionally, when
`applicable, at the same time DMEPA requests concurrence/non-concurrence with
`OPDP’s decision on the name. The primary Safety Evaluator addresses any comments or
`concerns in the safety evaluator’s assessment.
`The OND/OGD Regulatory Division is contacted a second time following our analysis of
`the proposed proprietary name. At this point, DMEPA conveys their decision to accept
`or reject the name. The OND or OGD Regulatory Division is requested to provide any
`further information that might inform DMEPA’s final decision on the proposed name.
`Additionally, other review disciplines opinions such as ONDQA or OBP may be
`considered depending on the proposed proprietary name.
`When provided, DMEPA considers external proprietary name studies conducted by or for
`the Applicant/Sponsor and incorporates the findings of these studies into the overall risk
`assessment.
`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
`
`Phonetic Checklist
`Y/N Do the names have different
`number of syllables?
`
`Y/N Do the names have different
`syllabic stresses?
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`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?
`
`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?
`
`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
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`

`(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.
`
`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?
`
`
`
`Reference ID: 4083609
`
`12
`
`

`

` 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