CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`207202Orig1s000
`
`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 14, 2017
`Application Type and Number: NDA 207202
`Product Name and Strength:
`Abilify MyCite (aripiprazole + ingestible event
`marker) tablets
`2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg
`Combination Product
`Rx
`Otsuka Pharmaceutical Company, Ltd.
`2017-14615908
`Loretta Holmes, BSN, PharmD
`Lolita White, PharmD
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Team Leader:
`
`Reference ID: 4124829
`
`

`

`1
`
`Contents
`INTRODUCTION....................................................................................................................1
`1.1
`Regulatory History............................................................................................................1
`1.2
`Product Information ..........................................................................................................1
`2 RESULTS.................................................................................................................................2
`2.1 Misbranding Assessment ..................................................................................................2
`2.2
`Safety Assessment.............................................................................................................2
`3 CONCLUSIONS......................................................................................................................5
`3.1
`Comments to the Applicant...............................................................................................5
`4 REFERENCES.........................................................................................................................6
`APPENDICES .................................................................................................................................7
`
`
`
`Reference ID: 4124829
`
`

`

`INTRODUCTION
`1
`This review evaluates the proposed proprietary name, Abilify MyCite, 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 submitted an
`external name study, conducted by
`, for this product.
`
`REGULATORY HISTORY
`1.1
`The Applicant, Otsuka Pharmaceutical Company, Ltd., previously submitted the proposed
`proprietary name, Abilify MyCite***, on December 2, 2015. The name was found conditionally
`acceptable in OSE Review #2180714, dated February 22, 2016. a However, the NDA
`application received a Complete Response (CR) action on April 26, 2016. On April 21, 2017,
`Otsuka submitted a Class II resubmission of the NDA as well as a Request for Proprietary Name
`Review of Abilify MyCite.
`
`PRODUCT INFORMATION
`1.2
`The following product information is provided in the April 21, 2017 proprietary name
`submission.
`Intended Pronunciation: Abilify MY-site
`
` Active Ingredient: aripiprazole
`Indication of Use: Abilify MyCite is a combination of Abilify (an atypical antipsychotic)
`
`embedded with an Ingestible Event Marker (IEM) that communicates with a Patch
`(wearable sensor) and a medical software application.
` is indicated for the treatment of:
`o Schizophrenia
`o Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder
`o Adjunctive Treatment of Major Depressive Disorder
` Route of Administration: Oral
` Dosage Form: Tablets
` Strengths: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg
` Dose and Frequency: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg orally once daily
` How Supplied: 30-count bottles of aripiprazole + IEM tablets and wearable sensors
` Storage: Tablets: Store at 25°C (77°F); excursions permitted betwe n 15°C to 30°C
`(59°F to 86°F); Wearable Sensor: Store between 15°C and 30°C (59°F to 86°F), 15% to
`93% relative humidity.
`
`
`
`a Holmes L. Proprietary Name Review for Abilify MyCite (NDA 207202). Silver Spring (MD): FDA, CDER, OSE,
`DMEPA (US); 2016 Feb 22. RCM No.: 2015-2180714.
`
`Reference ID: 4124829
`
`1
`
`(b)
`(4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`2 RESULTS
`The following sections provide information obtained and considered in the overall evaluation of
`the proposed proprietary name.
`
`2.1 MISBRANDING ASSESSMENT
`The Office of Prescription Drug Promotion (OPDP) determined that the proposed name would
`not misbrand the proposed product. DMEPA and the Division of 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.b
`
`2.2.2 Components of the Proposed Proprietary Name
`The name Abilify MyCite is comprised of the root name, Abilify (an FDA approved proprietary
`name) and the modifier “MyCite”. The Applicant also indicated the following in their
`submission:
`The proposed proprietary name for the three-part medical device system is ABILIFY MYCITE.
`The modifier MYCITE is the proposed name for the three-part medical device system and it will
`be used in combination with the drug ABILIFY.
`The modifier MYCITE (pronounced MY-site) is meant to subtlety suggest “my information”,
`which communicates that the aripiprazole + IEM combination drug-device and associated
`system provides patients with a view of their personalized medical information, providing
` biometric data, and supporting communication between patients, caregivers and
`
`HCPs.
`The root name “Abilify” was previously assessedc and a determination was made that it is
`appropriate for this product. We have no outstanding concerns with the root name and we
`continue to find the proposed root name acceptable. Our analysis of the appropriateness of the
`modifier is discussed in Section 2.2.5.
`
`2.2.3 Comments from Other Review Disciplines at Initial Review
`In response to the OSE, May 5, 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.
`
`b USAN stem search conducted on May 16, 2017.
`
`c Holmes L. Proprietary Name Review for Abilify MyCite (NDA 207202). Silver Spring (MD): FDA, CDER, OSE,
`DMEPA (US); 2016 Feb 22. RCM No.: 2015-2180714.
`
`Reference ID: 4124829
`
`2
`
`(b) (4)
`
`

`

`2.2.4 FDA Name Simulation Studies
`
`Sixty-nine (69) practitioners participated in DMEPA’s prescription studies. Five participants in
`the prescription studies [outpatient (1), voice (1) and inpatient (3)], interpreted the name as
`“Abilify” and did not include the modifier “MyCite” in their response. We discuss the risk
`associated with the omission of the modifier in Section 2.2.5.
`
`Appendix B contains the results from the verbal and written prescription studies.
`
`2.2.5 Safety assessment ofthe modifier, MyCite
`
`The modifier “MyCite” was previously assessed‘1 and a determination was made that a modifier
`is necessary and that the modifier “MyCite” is appropriate for this product. We have no
`outstanding concerns with the modifier and we continue to find the proposed modifier acceptable
`because of the following reasons:
`
`mm) was submitted in support of the name Abilify
`An external name study by
`MyCite with the initial name submission in 2015 and again in support of the crnrent name
`submission. We previously evaluated the external study and concrnred with
`conclusion. For the current name submission,
`(m4) conducted a gap analysis and
`name safety evaluation to assess whether any new potential conflicts had arisen in the interim
`period between their initial primary research (2013) and the present (February 2017). The drug
`name Mytesi was identified in their gap search.
`
`(0) (4)
`
`We evaluated the risk of confusion between Abilify MyCite and the name Mytesi that was
`identified in the
`”(4) external study as having similarity to the modifier MyCite.
`m4) determined that although there is moderate orthographic and phonetic
`similarity between Abilify MyCite and Mytesi, Mycite will be linked to the root name Abilify,
`which significantly limits the potential for confusion. Also, differences in product characteristics
`will limit the potential for confusion and medication errors. Thus,
`a» (4’ concluded
`that Abilify MyCite and Mytesi do not have a high probability of medication errors due to
`proprietary name confusion. We agree with
`“(4) assessment and find that the
`names Abilify MyCite and Mytesi can safely coexist in the marketplace.
`
`In our evaluation, we also considered the risk of name confusion if the modifier “MyCite” is
`dropped. We note that omission and oversight of modifiers is cited in literature as a common
`cause of medication errors.‘ Although modifiers may be omitted, when used, they can assist in
`differentiating products and may help to prevent potential product selection errors. Postmarket
`experience shows that the introduction of product line extensions may result in medication errors
`if the modifier is omitted and the product characteristics are similar or overlap. An alternative to
`using a modifier to distinguish this product from the currently marketed products is to use a
`different root name. However, marketing the new product under a unique proprietary name also
`
`‘1 Holmes L. Proprietary Name Review for Abilify MyCite (NDA 207202). Silver Spring (MD): FDA. CDER. OSE.
`DMEPA (US): 2016 Feb 22. RCM No.2 2015-2180714.
`
`e Lesar' TS. Prescribing Errors Involving Medication Dosage Forms. J Gen Intern Med. 2002: 17(8): 579-587.
`
`Reference ID: 4124829
`
`3
`
`

`

`carries a risk of medication errors, such as therapeutic duplication and overdoses. These errors
`may have greater associated safety risks than the omission or oversight of the modifier as
`discussed above.
`Thus, given the totality of factors considered above, we conclude that the modifier “Mycite” is
`acceptable for the proposed product.
`
`2.2.6 Medication Error Data Selection of Cases
`We searched the FDA Adverse Event Reporting System (FAERS) database using the strategy
`listed in Table 2 (see Appendix A1 for a description of FAERS database) for name confusion
`errors involving the proprietary name, Abilify, that would be relevant for this review.
`
`Event (MedDRA
`Terms)
`
`Table 2. FAERS Search Strategy
`Search Date
`June 21, 2017
`Drug Name
`Product name: Abilify, Abilify Discmelt, Abilify
`Maintena
`Active Ingredient: aripiprazole
`Product Verbatim: Abilify
`DMEPA Official PNR Name Confusion Search
`Terms Event List:
`Preferred Terms:
`CIRCUMSTANCE OR INFORMATION CAPABLE OF
`LEADING TO MEDICATION ERROR
`DRUG ADMINISTRATION ERROR
`DRUG DISPENSING ERROR
`DRUG PRESCRIBING ERROR
`INTERCEPTED DRUG DISPENSING ERROR
`INTERCEPTED DRUG PRESCRIBING ERROR
`INTERCEPTED MEDICATION ERROR
`MEDICATION ERROR
`PRODUCT NAME CONFUSION
`TRANSCRIPTION MEDICATION ERROR
`
`Lower Level Terms:
`INTERCEPTED PRODUCT SELECTION ERROR
`INTERCEPTED WRONG DRUG PRODUCT SELECTED
`INTERCEPTED WRONG DRUG SELECTED
`PRODUCT SELECTION ERROR
`WRONG DEVICE DISPENSED
`WRONG DRUG ADMINISTERED
`WRONG DRUG DISPENSED
`WRONG DRUG PRESCRIBED
`WRONG DRUG PRODUCT SELECTED
`
`Reference ID: 4124829
`
`4
`
`

`

`Date Limits
`
`Table 2. FAERS Search Strategy
`WRONG DRUG SELECTED
`WRONG PRODUCT SELECTED
`PREFERRED TERM:
`MEDICATION ERROR
`Gap Search: January 26, 2016 (end date of our
`previous search in OSE Review #2015-2180714) to
`June 21, 2017
`Our search retrieved 38 cases. Each report was reviewed for relevancy and duplication.
`Duplicates were merged into a single case. The NCC MERP Taxonomy of Medication Errors
`was used to code the case outcome and error root causes when provided by the reporter.
`After individual review, these 38 cases were excluded from final analysis because they did not
`describe confusion between the name Abilify and another US drug name. Thus, we continue to
`find the use of the root name, Abilify, acceptable for the proposed product.
`
`2.2.7 Communication of DMEPA’s Analysis at Midpoint of Review
`DMEPA communicated our findings to the Division of Psychiatry Products (DPP) via e-mail on
`July 7, 2017. At that time, we also requested additional information or concerns that could
`inform our review. Per e-mail correspondence from DPP on July 14, 2017, they stated no
`additional concerns with the proposed proprietary name, Abilify MyCite.
`
`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, Abilify MyCite, and have
`concluded that this name is acceptable.
`If any of the proposed product characteristics as stated in your April 21, 2017 submission are
`altered prior to approval of the marketing application, the name must be resubmitted for review.
`
`Reference ID: 4124829
`
`5
`
`

`

`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.
`
`Reference ID: 4124829
`
`6
`
`

`

`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
`
`f National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
`
`Reference ID: 4124829
`
`7
`
`

`

`*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: 4124829
`
`8
`
`

`

`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.
` 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.
`
`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: 4124829
`
`9
`
`

`

`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: 4124829
`
`10
`
`

`

`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?
`
`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
`
`Reference ID: 4124829
`
`11
`
`

`

`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: 4124829
`
`12
`
`

`

`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: 4124829
`
`13
`
`

`

`Appendix A1: Description of FAERS
`The FDA Adverse Event Reporting System (FAERS) is a database that contains information on
`adverse event and medication error reports submitted to FDA. The database is designed to
`support the FDA's postmarket safety surveillance program for drug and therapeutic biologic
`products. The informatic structure of the FAERS database adheres to the international safety
`reporting guidance issued by the International Conference on Harmonisation. FDA’s Office of
`Surveillance and Epidemiology codes adverse events and medication errors to terms in the
`Medical Dictionary for Regulatory Activities (MedDRA) terminology. Product names are coded
`using the FAERS Product Dictionary. More information about FAERS can be found at:
`http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDr
`ugEffects/default.htm.
`
`Reference ID: 4124829
`
`14
`
`

`

`Appendix B: Prescription Simulation Samples and Results
`Figure 1. Abilify MyCite Study (Conducted on May 15, 2017)
`
`Handwritten Medication Order/Prescription
`Medication Order:
`
`Outpatient Prescription:
`
`Verbal Prescription
`Abilify MyCite 20 mg
`Take one tablet by
`mouth once daily
`Dispense: 1kit
`
`Reference ID: 4124829
`
`15
`
`

`

`FDA Prescription Simulation Responses (Aggregate 1 Rx Studies Report)
`
` 296 People Received Study
` 69 People Responded
`
`Study Name: Abilify MyCite
`Total
`
`22
`
`18
`
`29
`
`
`
`INTERPRETATION
`
`OUTPATIENT
`
`VOICE
`
`INPATIENT
`
`TOTAL
`
`ABILFY MISITE
`
`ABILIFY
`
`ABILIFY MCCILE
`
`ABILIFY MGCITE
`
`ABILIFY MICITE
`
`ABILIFY MY CITE
`
`ABILIFY MY SIGHT
`
`ABILIFY MYCATE
`
`0
`
`1
`
`1
`
`2
`
`1
`
`0
`
`0
`
`0
`
`1
`
`1
`
`0
`
`0
`
`0
`
`0
`
`2
`
`0
`
`0
`
`3
`
`0
`
`1
`
`0
`
`4
`
`0
`
`2
`
`1
`
`5
`
`1
`
`3
`
`1
`
`4
`
`2
`
`2
`
`ABILIFY MYCILE
`
`ABILIFY MYCIRE
`
`ABILIFY MYCITE
`
`ABILIFY MYLATE
`
`ABILIFY MYSIDE
`
`ABILIFY MYSIGHT
`
`ABILIFY MYSITE
`
`ABILIFYMY CITE
`
`ABILIFYMY SIGHT
`
`ABILITY MYSITE
`
`1
`
`0
`
`16
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`3
`
`0
`
`1
`
`3
`
`5
`
`0
`
`1
`
`1
`
`0
`
`1
`
`16
`
`1
`
`0
`
`0
`
`0
`
`1
`
`0
`
`0
`
`1
`
`1
`
`35
`
`1
`
`1
`
`3
`
`5
`
`1
`
`1
`
`1
`
`Reference ID: 4124829
`
`16
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`LORETTA HOLMES
`07/14/2017
`
`LOLITA G WHITE
`07/14/2017
`
`Reference ID: 4124829
`
`

`

`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 22, 2016
`Application Type and Number: NDA 207202
`Product Name and Strength:
`Abilify Mycite (aripiprazole plus ingestible event
`marker) Tablets
`2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg
`Combination Product
`Rx
`Otsuka Pharmaceutical Company, Ltd.
`2015-2180714
`Loretta Holmes, BSN, PharmD
`Danielle Harris, PharmD, BCPS
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Team Leader:
`
`Reference ID: