CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`
`
`
`APPLICATION NUMBER:
`
`
`210875Orig1s000
`
`
`PROPRIETARY NAME REVIEW(S)
`
`
`
`
`
`
`
`
`

`

`PROPRIETARY NAME MEMORANDUM
`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 28, 2020
`Application Type and Number: NDA 210875
`Product Name and Strength:
`
` sublingual film, 10 mg, 15 mg,
`Kynmobi
`20 mg, 25 mg, and 30 mg
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Team Leader:
`
`Single Ingredient Product
`
`Prescription (Rx)
`
`Sunovion Pharmaceuticals Inc (Sunovion)
`
`2020-39055498
`
`Justine Kalonia, PharmD
`
`Briana Rider, PharmD, CPPS
`
`
`
`Reference ID: 4599123Reference ID: 4613103
`
`(b) (4)
`
`

`

`1
`
`INTRODUCTION
`
`This memorandum is to reassess the proposed proprietary name, Kynmobi, which was found
`unacceptable under NDA 210875 on July 24, 2019 and February 18, 2020.ab The proposed
`proprietary name, Kynmobi, was found to be vulnerable to medication errors due to confusion
`***, under review at the time. Therefore, the ultimate
`with another product,
`acceptability of the proposed proprietary name, Kynmobi, was dependent upon which underlying
`application was approved first.
`
`We note that the goal date for NDA 210875 is May 21, 2019, whereas the underlying application
`for
` status. Therefore, if the proposed proprietary name, Kynmobi, is
`granted approval under NDA 210875 on or before May 21, 2019, this application approval will
`***.
`precede approval of the application with the conflicting proposed name,
`
`Thus, Sunovion resubmitted the proposed proprietary name, Kynmobi, for review on April 2,
`2020.
`
`2 METHODS AND DISCUSSION
`
`2.1 SAFETY ASSESSMENT
`
`For re-assessment of the proposed proprietary name, DMEPA 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 proposed proprietary
`name. Additionally, DMEPA searched the USAN stem list to determine if the name contains any
`
`USAN stems as of the last USAN updates. The April 9, 2020 search of USAN stems did not find
`any USAN stems in the proposed proprietary name.
`
`Finally, DMEPA evaluated the status of the underlying application of the conflicting name,
`***, and determined that if NDA 210875 for Kynmobi is approved on or before the
`May 21, 2019, this application approval will precede approval of the application with the
`*** given the underlying application for
`***
`conflicting proposed name,
`
` status.
`
`Based upon our safety assessment of the proposed proprietary name, Kynmobi, the application
`
`***, we find
`goal date for NDA 210875, and the status of the underlying application for
`Kynmobi conditionally acceptable.
`
`2.2 COMMUNICATION OF DMEPA’S ANALYSIS
`
` DMEPA communicated our findings to the Division of Division of Neurology 1 (DN 1) via e­
`
`mail on April 21, 2020. At that time, we also requested additional information or concerns that
`could inform our review. Per e-mail correspondence from the Division of Neurology 1 (DN 1)
`
`
`
` a Owens, L. Proprietary Name Review Memo for Kynmobi (NDA 210875). Silver Spring (MD): FDA, CDER, OSE,
`DMEPA (US); 2019 JUL 24. Panorama No. 2018-22076836-1.
`
`b Morris, C. Proprietary Name Review for Kynmobi (NDA 210875). Silver Spring (MD): FDA, CDER, OSE,
`DMEPA (US); 2020 FEB 18. Panorama No. 2019-35948893.
`
`
`
`Reference ID: 4599123Reference ID: 4613103
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`on April 28, 2020, they stated no additional concerns with the proposed proprietary name,
`Kynmobi.
`
`3 CONCLUSIONS
`We conclude that the proposed proprietary name, Kynmobi, is acceptable.
`
`If you have any questions or need clarifications, please contact Casmir Ogbonna, OSE project
`manager, at 301-796-5272.
`
`3.1 COMMENTS TO SUNOVION PHARMACEUTICALS INC
`
`
`We have completed our review of the proposed proprietary name, Kynmobi, and have concluded
`that this name is acceptable.
`
`If any of the proposed product characteristics as stated in your submission, received on April 2,
`2020, are altered prior to approval of the marketing application, the name must be resubmitted
`for review.
`
`If your application receives a complete response, please submit a new request for review of your
`proposed proprietary name when you respond to the application deficiencies.
`
`
`
`Reference ID: 4599123Reference ID: 4613103
`
`

`

`
`
` 4 REFERENCES
`
`1. USAN Stems (https://www.ama-assn.org/about/united-states-adopted­
`
`names/united-states-adopted-names-approved-stems)
`USAN Stems List contains all the recognized USAN stems.
`
`
`
`Reference ID: 4599123Reference ID: 4613103
`
`

`

`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/
`------------------------------------------------------------
`
`JUSTINE H KALONIA
`04/28/2020 08:43:41 AM
`
`BRIANA B RIDER
`04/28/2020 08:52:32 AM
`
`
`
`Reference ID: 4599123Reference ID: 4613103
`
`

`

`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:
`February 18, 2020
`Application Type and Number: NDA 210875
`Product Name and Strength:
`
`Kynmobi (apomorphine hydrochloride) sublingual
`
` film, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Panorama #:
`DMEPA Safety Evaluator:
`DMEPA Team Leader:
`DMEPA Deputy Director:
`
`Single Ingredient Product
`
`Prescription (Rx)
`
`Sunovion Pharmaceuticals Inc (Sunovion)
`
`2019-35948893
`
`Chad Morris, PharmD, MPH
`
`Briana Rider, PharmD, CPPS
`
`Danielle Harris, PharmD
`
`Reference ID: 4562674
`
`

`

`1
`
`
`Contents
`INTRODUCTION....................................................................................................................1
`
`Regulatory History...........................................................................................................1
`
`1.1
`Product Information.........................................................................................................1
`
`1.2
`2
` RESULTS.................................................................................................................................2
`
`2.1 Misbranding Assessment .................................................................................................2
`
`Safety Assessment ...........................................................................................................2
`
`2.2
`3
` CONCLUSION ........................................................................................................................4
`
`Comments to Sunovion Pharmaceuticals Inc ..................................................................4
`
`3.1
`4 REFERENCES .........................................................................................................................6
`
`APPENDICES .................................................................................................................................7
`
`
`
`
`Reference ID: 4562674
`
`

`

`1
`
`INTRODUCTION
`
`
`This review evaluates the proposed proprietary name, Kynmobi, from a safety and misbranding
`perspective. The sources and methods used to evaluate the proposed proprietary name are
`outlined in the reference section and Appendix A respectively. Sunovion submitted an updated
`, for this proposed proprietary name.
`external name study, conducted by
`
`1.1
`
`REGULATORY HISTORY
`
`The proposed proprietary name, Kynmobi, was previously submitted for review on September 1,
`2015. We found the name, Kynmobi, conditionally acceptable under IND 110955 on December
`9, 2015.a Thus, upon submission of NDA 210875, Sunovion re-submitted the proposed
`proprietary name, Kynmobi, on April 2, 2018. On June 8, 2018, we found the name
`conditionally acceptable b; however, NDA 210875 received a Complete Response (CR) Letter on
`January 29, 2019.
`
`F
`
`Since that time, we identified a conflict with another pending proposed proprietary name under
`review (OSE RCM# 2018-22076836-1).c The proposed name, Kynmobi, could result in
`***. Our evaluation of this name pair altered
`medication errors due to confusion with
`our previous conclusion regarding the acceptability of the proposed proprietary name, Kynmobi.
`
`We notified Sunovion via letter on July 25, 2019 that the proposed proprietary name, Kynmobi,
`is unacceptable due to potential medication errors due to confusion with another product’s
`proposed proprietary name that is also under review. We also informed Sunovion, the ultimate
`
`acceptability of the proposed proprietary name, Kynmobi, is dependent upon which underlying
`application is approved first.
`
`As part of the Class 2 resubmission in response to the CR, Sunovion re-submitted the name,
`Kynmobi, for review on November 21, 2019.
`
`1.2 PRODUCT INFORMATION
`
`The following product information is provided in the proprietary name submission received on
`November 21, 2019.
`
`
`Intended Pronunciation: kin moe' bee
` Active Ingredient: apomorphine hydrochloride
`
`
`Indication of Use: Acute, intermittent treatment of OFF episodes associated with
`Parkinson’s disease (PD)
`
`
`
`a Harris, J. Proprietary Name Review for Kynmobi (IND 110955). Silver Spring (MD): FDA, CDER, OSE, DMEPA
`(US); 2015 DEC 09. Panorama No. 2015-1367954.
`
`b Morris, C. Proprietary Name Review for Kynmobi (NDA 210875). Silver Spring (MD): FDA, CDER, OSE,
`DMEPA (US); 2019 JUN 08. Panorama No. 2018-22076836.
`
`c Owens, L. Proprietary Name Review MEMO for Kynmobi (NDA 210875). Silver Spring (MD): FDA, CDER,
`OSE, DMEPA (US); 2019 JUL 24. Panorama No. 2018-22076836-1.
`
`Reference ID: 4562674
`
`1
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

` Route of Administration: sublingual
` Dosage Form: sublingual film
` Strength: 10 mg, 15 mg, 20 mg, 25 mg, 30 mg
` Dose and Frequency: 10 mg
` up to 5 times daily
`
` How Supplied:
`
`o Titration Kit containing 10 sublingual films (2 sublingual films per strength)
`o Carton for each strength containing 30 sublingual films
` Storage: Store at 20°–25°C (68°–77°F); excursions permitted between 15°–30°C (59°–
`86°F).
`
` Reference Listed Drug/Reference Product: Apokyn, NDA 21264
`
`
`
`2 RESULTS
`
`The following sections provide information obtained and considered in the overall evaluation of
`the proposed proprietary name, Kynmobi.
`
`2.1 MISBRANDING ASSESSMENT
`
`The Office of Prescription Drug Promotion (OPDP) determined that Kynmobi would not
`misbrand the proposed product. The Division of Medication Error Prevention and Analysis
`(DMEPA) and the Division of Neurology 1 (DN 1) concurred with the findings of OPDP’s
`
`assessment for Kynmobi.
`
`2.2 SAFETY ASSESSMENT
`
`The following aspects were considered in the safety evaluation of the proposed proprietary name,
`Kynmobi.
`
`2.2.1 United States Adopted Names (USAN) Search
`
`There is no USAN stem present in the proposed proprietary name1F
`
`d.
`
`2.2.2 Components of the Proposed Proprietary Name
`
`
`Sunovion did not provide a derivation or intended meaning for the proposed proprietary name,
`
` Kynmobi, 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, December 5, 2019 e-mail, the Division of Neurology 1 (DN 1) did not
`forward any comments or concerns relating to Kynmobi at the initial phase of the review.
`
`d USAN stem search conducted on December 3, 2019.
`
`Reference ID: 4562674
`
`2
`
`
`(b) (4)
`
`

`

`2.2.4 FDA Name Simulation Studies
`
`
`Eighty-seven practitioners participated in DMEPA’s prescription studies for Kynmobi. 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 searche identified 8 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 reviews.a,b 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 1 name not previously
`analyzed. This name is included in Table 1 below.
`
`2.2.6 Names Retrieved for Review Organized by Name Pair Similarity
`
`Table 1 lists the number of names retrieved from our POCA search and the updated
`
`
`external study. 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:
`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%
`
`1
`
`0
`
`2
`
`2.2.7 Safety Analysis of Names with Potential Orthographic, Spelling, and Phonetic
`
`Similarities
`
`
`
`We determined 2 of the 3 names will not pose a risk for confusion with Kynmobi as described in
`Appendices C through H. However, the proposed proprietary name could be confused with
`***. The rationale for the risk of confusion
`another pending proposed proprietary name,
`
`is described in our Memo/Decision Amendment dated July 24, 2019c.
`
`e POCA search conducted on December 3, 2019 in version 4.3.
`
`Reference ID: 4562674
`
`3
`
`
`(b) (4)
`
`(b) (4)
`
`

`

`2.2.8 Communication of DMEPA’s Analysis at Midpoint of Review
`
` DMEPA communicated our findings to the Division of Neurology 1 (DN 1) via e-mail on
`
`February 14, 2020. At that time, we also requested additional information or concerns that could
`inform our review. Per e-mail correspondence from the Division of Neurology 1 (DN 1) on
`February 18, 2020, they stated no additional concerns with the proposed proprietary name,
`Kynmobi.
`
`3 CONCLUSION
`
`The proposed proprietary name, Kynmobi, is not acceptable from a safety perspective. The
`proposed proprietary name, Kynmobi, is vulnerable to name confusion with another product that
`***. Therefore, the decision to deny the name will be
`is also under review,
`communicated to Sunovion via letter (See Section 3.1).
`
`
`If you have further questions or need clarifications, please contact Casmir Ogbonna, OSE project
`manager, at 301-796-5272.
`
`3.1
`
`COMMENTS TO SUNOVION PHARMACEUTICALS INC
`
`
`We have completed our review of the proposed proprietary name, Kynmobi, and have concluded
`that this name is unacceptable for the following reasons:
`Kynmobi vs. pending proprietary name
`
`The proposed proprietary name, Kynmobi, could result in medication errors due to confusion
`with another product that is also under review. As previously described in our July 25, 2019
`correspondence, the ultimate acceptability of your proposed proprietary name, Kynmobi, is
`dependent upon which underlying application is approved first. If another product is approved
`prior to your product, with a name that would be confused with your proposed name Kynmobi,
`you will be requested to submit another name.
`
`external
`We acknowledge that our conclusion differs from that of the
`study submitted in support of the proposed proprietary name. However, the pending proprietary
`
` external study.
`name is also under review and thus was not identified by the
`
`Reference ID: 4562674
`
`4
`
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`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: 4562674
`
`5
`
`
`

`

`APPENDICES
`
`
`Appendix A
`
`FDA’s Proprietary Name Risk Assessment evaluates proposed proprietary names for
`
`misbranding and safety concerns.
`1. Misbranding Assessment: For prescription drug products, OPDP assesses the name for
`
`misbranding concerns. For over-the-counter (OTC) drug products, the misbranding
`
`assessment of the proposed name is conducted by DNDP. OPDP or DNDP evaluates
`proposed proprietary names to determine if the name is false or misleading, such as by
`
`making misrepresentations with respect to safety or efficacy. For example, a fanciful
`proprietary name may misbrand a product by suggesting that it has some unique
`
`effectiveness or composition when it does not (21 CFR 201.10(c)(3)). OPDP or DNDP
`
`provides their opinion to DMEPA for consideration in the overall acceptability of the
`proposed proprietary name.
`2. Safety Assessment: The safety assessment is conducted by DMEPA, and includes the
`
`following:
`a. Preliminary Assessment: We consider inclusion of USAN stems or other characteristics
`
`that when incorporated into a proprietary name may cause or contribute to medication
`errors (i.e., dosing interval, dosage form/route of administration, medical or product name
`
`abbreviations, names that include or suggest the composition of the drug product, etc.)
`See prescreening checklist below in Table 2*. DMEPA defines a medication error as any
`
`preventable event that may cause or lead to inappropriate medication use or patient harm
`while the medication is in the control of the health care professional, patient, or
`f
`consumer. F
`
`f National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
`
`Reference ID: 4562674
`
`6
`
`

`

`*Table 2- Prescreening Checklist for Proposed Proprietary Name
`
`Answer the questions in the checklist below. Affirmative answers
`to any of these questions indicate a potential area of concern that
`should be carefully evaluated as described in this guidance.
`Is the proposed name obviously similar in spelling and pronunciation to other
`names?
`
`Y/N
`
`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?
`
`Y/N
`
`Y/N
`
`Y/N
`
`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)).
`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.
`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.
`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: 4562674
`
`7
`
`
`

`

` 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 g. 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).
`
`F
`
` 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.
`
`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: 4562674
`
`8
`
`
`

`

`c. FDA Prescription Simulation Studies: DMEPA staff also conducts a prescription
`
`
`simulation studies using FDA health care professionals.
`
`
`Three separate studies are conducted within the Centers of the FDA for the proposed
`proprietary name to determine the degree of confusion of the proposed proprietary name
`
`with marketed U.S. drug names (proprietary and established) due to similarity in visual
`appearance with handwritten prescriptions or verbal pronunciation of the drug name. The
`studies employ healthcare professionals (pharmacists, physicians, and nurses), and
`attempts to simulate the prescription ordering process. The primary Safety Evaluator
`uses the results to identify orthographic or phonetic vulnerability of the proposed name to
`be misinterpreted by healthcare practitioners.
`
`In order to evaluate the potential for misinterpretation of the proposed proprietary name
`in handwriting and verbal communication of the name, inpatient medication orders and/or
`outpatient prescriptions are written, each consisting of a combination of marketed and
`unapproved drug products, including the proposed name. These orders are optically
`
`scanned and one prescription is delivered to a random sample of participating health
`professionals via e-mail. In addition, a verbal prescription is recorded on voice mail.
`The voice mail messages are then sent to a random sample of the participating health
`professionals for their interpretations and review. After receiving either the written or
`verbal prescription orders, the participants record their interpretations of the orders,
`which are recorded electronically.
`
`d. Comments from Other Review Disciplines: DMEPA requests the Office of New Drugs
`(OND) and/or Office of Generic Drugs (OGD), ONDQA or OBP for their comments or
`
`concerns with the proposed proprietary name, ask for any clinical issues that may impact
`the DMEPA review during the initial phase of the name review. Additionally, when
`applicable, at the same time DMEPA requests concurrence/non-concurrence with
`OPDP’s decision on the name. The primary Safety Evaluator addresses any comments or
`concerns in the safety evaluator’s assessment.
`
`The OND/OGD Regulatory Division is contacted a second time following our analysis of
`
`the proposed proprietary name. At this point, DMEPA conveys their decision to accept
`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: 4562674
`
`9
`
`
`

`

`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
`
`Phonetic 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 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
`
`Is there different number or
`placement of cross-stroke or dotted
`letters present in the names?
`
`Y/N Across a range of dialects, are
`the names consistently
`pronounced differently?
`
`Y/N Do the infixes of the name appear
`dissimilar when scripted?
`
`Y/N Do the suffixes of the names appear
`dissimilar when scripted?
`
`Reference ID: 4562674
`
`10
`
`

`

`
`
` 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