CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`206439Orig1s000
`
`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***
`
`May 15, 2014
`Date of This Review:
`Application Type and Number: NDA 206439
`Namzaric (Memantine and Donepezil) extended-release capsules
`Product Name and Strength:
`14 mg/10 mg, 28mg/10 mg
`Multi-ingredient
`Rx
`Forest Research Institute, Inc.
`February 27, 2014
`2014-17012
`Justine Harris, RPh
`Julie Villanueva Neshiewat, PharmD, BCPS
`Tingting Gao, PharmD
`Kellie A. Taylor, Pharm.D., MPH
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Submission Date:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Acting Team Leader:
`DMEPA Acting Team Leader:
`DMEPA Deputy Director
`
`Reference ID: 3508318
`
`

`

`1
`
`Contents
`INTRODUCTION....................................................................................................... 1
`1.1
`Product Information ............................................................................................. 1
`2 RESULTS.................................................................................................................... 1
`2.1
`Promotional Assessment ...................................................................................... 2
`2.2
`Safety Assessment................................................................................................ 2
`3 DISCUSSION.............................................................................................................. 3
`4 CONCLUSIONS ......................................................................................................... 4
`4.1
`Comments to the Applicant.................................................................................. 4
`5 REFERENCES ............................................................................................................ 5
`APPENDICES .................................................................................................................... 6
`
`Reference ID: 3508318
`
`

`

`INTRODUCTION
`1
`This review evaluates the proposed proprietary name, Namzaric, from a safety and
`promotional 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.
`
`PRODUCT INFORMATION
`1.1
`The following product information is provided in the February 27, 2014 proprietary name
`submission.
`Intended Pronunciation: nam-ZAIR-ick
`
` Active Ingredients: memantine HCl /donepezil HCl
`Indication of Use: Treatment of moderate to severe dementia of the Alzheimer’s type
`
` Route of Administration: Oral
` Dosage Form: extended-release capsules1
` Strengths:
`o 14 mg memantine/10 mg donepezil HCl
`o 28 mg memantine/10 mg donepezil HCl
` Dose and Frequency: The usual dosage is 28 mg/10 mg once daily. The
`maximum daily dose is 28 mg/10 mg. For patients with severe renal impairment
`a dose of 14 mg/10 mg once daily is recommended.
` How Supplied:
`o The 14 mg/10 mg capsule product will be available in 30-count bottle, 90
`count bottle,
`o The 28 mg/10 mg capsule product will be available in 30-count bottle, 90-
`count bottle,
`
`
` Storage: This product should be stored at 25 C (77F); excursions permitted
`between 15C - 30 C (59F - 86F).
`
`
`2 RESULTS
`The following sections provide information obtained and considered in the overall
`evaluation of the proposed proprietary name.
`
`
`1 Chemistry, Manufacturing, and Controls (CMC) has determined this dosage form will be designated as
`extended-release capsules
`
`Reference ID: 3508318
`
`1
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`2.1 PROMOTIONAL ASSESSMENT
`The Office of Prescription Drug Promotion (OPDP) determined the proposed name is
`acceptable from a promotional perspective. DMEPA and the Division of Neurology
`Products (DNP) concurred with the findings of OPDP’s promotional 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 name2.
`
`2.2.2 Components of the Proposed Proprietary Name
`The Applicant indicated in their submission that the proposed name, Namzaric, is derived
`from Namenda and Aricept. 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. Since this product will be
`designated as an extended-release capsule, we considered if a modifier was needed to
`convey its extended-release properties (See Discussion, Section 3).
`
`2.2.3 FDA Name Simulation Studies
`One hundred and fourteen practitioners participated in DMEPA’s prescription studies.
`The interpretations did not overlap with any currently marketed products nor did the
`misinterpretations sound or look similar to any currently marketed products or any
`products in the pipeline.
`Twenty-one (26%) participants correctly interpreted the name, Namzaric, in the written
`prescription studies, and one participant in the verbal study. Nine participants (27%) in
`the verbal prescription study misinterpreted the letter ‘a’ in the letter string ‘Nam’ as an
`‘e’ and seven participants in the written studies interpreted this ‘a’ as ‘u’. Thirty-six
`participants (45%) misinterpreted the ending letter string ‘-zaric’ as ‘-zani’ and fifteen
`(19%) misinterpreted this letter string as ‘-raric’ in the written studies. Eleven
`participants (32%) misinterpreted the ‘c’ for a ‘k’ in the verbal prescription study.
`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, March 14, 2014 e-mail, the Division of Neurology Products
`(DNP) did not forward any comments or concerns relating to the proposed proprietary
`name at the initial phase of the review.
`
`
`2USAN stem search conducted on March 14, 2014.
`
`Reference ID: 3508318
`
`2
`
`

`

`2.2.5 Phonetic and Orthographic Computer Analysis (POCA) Search Results
`
`Table 1 lists the number of names with the combined orthographic and phonetic score of
`2 50% retrieved from our POCA search organized as highly similar, moderately similar,
`or low similarity for further evaluation. Table 1 also includes names identified from the
`FDA Prescription Simulation and by
`(but) health.
`
`Table 1. POCA Search Results
`
`Names
`
`Highly similar name pair:
`combined match percentage score 2 70%
`
`combined match percentage score 5 49%
`
`Moderately similar name pair:
`
`combined match percentage score 2 50% to S 69%
`
`Low similarity name pair:
`
`2.2.6 Safety Analysis ofNames with Potential Orthographic, Spelling, and
`Phonetic Similarities
`
`Our analysis of the seventy-six names contained in Table 1 determined none of the names
`would pose a risk for confusion as described in Appendices C through G.
`
`2.2. 7 Communication ofDMEPA ’s Analysis at Midpoint ofReview
`
`DMEPA communicated our findings to the Division of Neurology Products ODNP) via e-
`mail on May 2, 2014. At that time, we also requested additional information or concerns
`that could inform our review. Per e-mail correspondence from the DNP on May 5, 2014,
`they stated no additional concerns with the proposed proprietary name, Namzaric.
`
`3 DISCUSSION
`
`As proposed, the Applicant does not include a modifier with the name (e.g., ER, XR, XL)
`to convey that Namzaric is an extended—release capsule. Since the product contains the
`extended release component Namenda XR, it would seem reasonable to add the modifier
`‘XR’ to the name, however, we are not recommending that a modifier be included based
`on the reasons described below;
`
`Since there is no immediate-release formulation for this multi—ingredient drug product, it
`may not be necessary to include a modifier as part of the proprietary name, Namzaric. In
`addition, adding a modifier such as ‘XR’ to Namzaric may contribute to product
`confusion with the currently marketed product, Namenda XR, by increasing the
`orthographic similarity between the name pair Namzaric XR and Namenda XR. The
`orthographic similarity stems from both names having a similar length, beginning with
`the letter string ‘Nam,’ and ending with the modifier ‘XR’. Additionally, the FDA
`Phonetic and Orthographic Computer Analysis (POCA) indicates that if the modifier
`“XR” is added to Namzaric, the POCA score increases from 44% (low similarity) to
`
`Reference ID: 3508318
`
`

`

`64% (moderate similarity) when compared to Namenda XR. This increase in POCA
`score, when the modifier “XR” is added, may demonstrate a higher potential for product
`confusion to occur.
`Modifiers may be used to convey frequency of administration as well as technique of
`administration (i.e. can the product be manipulated or does it need to be swallowed
`whole). We do not anticipate that Namzaric is prone to be administered with wrong
`frequency as both active ingredients in this multi-ingredient product are administered
`once daily. In regard to technique of administration, a modifier is not needed to convey
`that this product should not be manipulated prior to administration since the capsules may
`be opened and sprinkled on food. Based on our findings presented above, we determined
`a modifier is not necessary for Namzaric, and the absence of a modifier will not introduce
`any new risks of errors.
`
`4 CONCLUSIONS
`The proposed proprietary name is acceptable from both a promotional and safety
`perspective.
`If you have further questions or need clarifications, please contact Ermias Zerislassie,
`OSE project manager, at 301-796-0097.
`
`COMMENTS TO THE APPLICANT
`4.1
`We have completed our review of the proposed proprietary name, Namzaric, and have
`concluded that this name is acceptable.
`If any of the proposed product characteristics as stated in your March 3, 2014 submission
`are altered, the name must be resubmitted for review.
`
`Reference ID: 3508318
`
`4
`
`

`

`5 REFERENCES
`
`1. USAN Stems (http://www.ama-assn.org/ama/pub/physician-resources/medical-
`science/united-states-adopted-names-council/naming-guidelines/approved-
`stems.page)
`USAN Stems List contains all the recognized USAN stems.
`
`2. Phonetic and Orthographic Computer Analysis (POCA)
`POCA is a system that FDA designed. As part of the name similarity assessment, POCA
`is used to evaluate proposed names via a phonetic and orthographic algorithm. The
`proposed proprietary name is converted into its phonemic representation before it runs
`through the phonetic algorithm. Likewise, an orthographic algorithm exists that operates
`in a similar fashion. POCA is publicly accessible.
`Drugs@FDA
`Drugs@FDA is an FDA Web site that contains most of the drug products approved in the
`United States since 1939. The majority of labels, approval letters, reviews, and other
`information are available for drug products approved from 1998 to the present.
`Drugs@FDA contains official information about FDA-approved brand name and generic
`drugs; therapeutic biological products, prescription and over-the-counter human drugs;
`and discontinued drugs (see Drugs @ FDA Glossary of Terms, available at
`http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm#ther biological).
`
`RxNorm
`
`RxNorm contains the names of prescription and many OTC drugs available in the United
`States. RxNorm includes generic and branded:
`
` Clinical drugs – pharmaceutical products given to (or taken by) a patient with
`therapeutic or diagnostic intent
` Drug packs – packs that contain multiple drugs, or drugs designed to be
`administered in a specified sequence
`
`Radiopharmaceuticals, contrast media, food, dietary supplements, and medical devices,
`such as bandages and crutches, are all out of scope for RxNorm
`(http://www.nlm.nih.gov/research/umls/rxnorm/overview.html#).
`
`Division of Medication Errors Prevention and Analysis proprietary name consultation
`requests
`This is a list of proposed and pending names that is generated by the Division of
`Medication Error Prevention and Analysis from the Access database/tracking system.
`
`Reference ID: 3508318
`
`5
`
`

`

`APPENDICES
`
`Appendix A
`
`FDA’s Proprietary Name Risk Assessment considers the promotional and safety aspects
`of a proposed proprietary name.
`
`1. Promotional Assessment: For prescription drug products, the promotional
`review of the proposed name is conducted by OPDP. For over-the-counter (OTC)
`drug products, the promotional review of the proposed name is conducted by
`DNCE. OPDP or DNCE evaluates proposed proprietary names to determine if
`they are overly fanciful, to misleadingly imply unique effectiveness or
`composition, as well as to assess whether they contribute to overstatement of
`product efficacy, minimization of risk, broadening of product indications, or
`making of unsubstantiated superiority claims. OPDP or DNCE 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 fomi/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*. DIVIEPA 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.
`3
`
`*Table 2- Prescreening Checklist for Proposed Proprietary Name
`
`Affirmative answers to these questions indicate a potential area
`of concern.
`
`other Names?
`
`Y/N
`
`Does the name have obvious Similarities in Spelling and Pronunciation to
`
`3 National Coordinating Council for Medication Error Reporting and Prevention.
`llflpi//WWVV nccmerporgZaboutMedErrors html. Last accessed 10/11/2007.
`
`Reference ID: 3508318
`
`

`

`
`
`Y/N
`
`Are there Manufacturin . Characteristics in the Pro riet. Name?
`
`Are there Medical and/or Coined Abbreviations in the Proprietary Name?
`Are there Inert or Inactive In edients referenced in the Pro -.riet Name?
`
`Does the Proprietary Name include combinations of Active Ingredients
`Is there a United States Adopted Name (USAN) Stem in the Proprietary
`Name?
`
`
`
`Is this the same Proprietary Name for Products containing Different Active
`In u edients?
`
`Is this a Proprietary Name of a discontinued product?
`
`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, CemerRxNorm, and names in the review
`pipeline using a 50% 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 270%.
`
`Moderately similar pair: combined match percentage score 250% to 5 69%.
`
`Low similarity: combined match percentage score 349%.
`
`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. Based on our root cause analysis of post marketing
`experience errors, we find the expression of strength and dose, which is often located
`in close proximity to the drug name itself on prescriptions and medication orders, is
`an important factor in mitigating or potentiating confusion between similarly named
`drug pairs. The ability of other product characteristics to mitigate confusion is
`limited (e.g., route, frequency, dosage form, etc.).
`
`For highly similar names, there is little that can mitigate a medication error,
`including product differences such as strength and dose. Thus, proposed
`proprietary names that have a combined score of 2 70 percent are likely to be
`rejected by FDA. (See Table 3)
`Moderately similar names with overlapping or similar strengths or doses represent
`an area for concern for FDA. The dosage and strength information is often
`located in close proximity to the drug name itself on prescriptions and medication
`orders 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 (e.g., route, frequency, dosage form, etc.) to mitigate confusion
`may be limited when the strength or dose overlaps. FDA will review these names
`
`Reference ID: 3508318
`
`

`

`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 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 (See Table 5).
`
`c. FDA Prescription Simulation Studies: DMEPA staff also conducts a prescription
`simulation studies using FDA health care professionals.
`Three separate studies are conducted within the Centers of the FDA for the proposed
`proprietary name to determine the degree of confusion of the proposed proprietary
`name with marketed U.S. drug names (proprietary and established) due to similarity
`in visual appearance with handwritten prescriptions or verbal pronunciation of the
`drug name. The studies employ healthcare professionals (pharmacists, physicians,
`and nurses), and attempts to simulate the prescription ordering process. The primary
`Safety Evaluator uses the results to identify orthographic or phonetic vulnerability of
`the proposed name to be misinterpreted by healthcare practitioners.
`In order to evaluate the potential for misinterpretation of the proposed proprietary
`name in handwriting and verbal communication of the name, inpatient medication
`orders and/or outpatient prescriptions are written, each consisting of a combination of
`marketed and unapproved drug products, including the proposed name. These orders
`are optically scanned and one prescription is delivered to a random sample of
`participating health professionals via e-mail. In addition, a verbal prescription is
`recorded on voice mail. The voice mail messages are then sent to a random sample of
`the participating health professionals for their interpretations and review. After
`receiving either the written or verbal prescription orders, the participants record their
`interpretations of the orders, which are recorded electronically.
`
`Reference ID: 3508318
`
`8
`
`

`

`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 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 (see Step 1 of the Moderately Similar Checklist).
`
`Orthographic Checklist
`
`Phonetic Checklist
`
`Y/N
`
`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.
`Are the lengths of the names
`dissimilar* when scripted?
`
`*FDA considers the length of names
`
`Y/N
`
`Do the names have
`different number of
`syllables?
`
`Y/N
`
`Do the names have
`different syllabic stresses?
`
`Reference ID: 3508318
`
`9
`
`

`

`
`
`dilflrem ifthe names dzfiy by two or
`more letters.
`
`Considering variations in
`scripting of some letters (such
`as : andf), is there a different
`number or placement of
`upstroke/downstroke letters
`present in the names?
`
`Do the syllables have
`different phonologic
`processes, such vowel
`reduction, assimilation, or
`deletion?
`
`
`
`Is there different number or
`placement of cross-stroke or
`dotted letters present in the
`names?
`
`Across a range of dialects,
`are the names consistently
`pronounced differently?
`
`Do the infixes of the name
`
`appear dissimilar when
`scripted?
`
`Do the suffixes of the names
`
`appear dissimilar when
`
`scripted?
`
`
`Table 4: Moderately Similar Name Pair Checklist (i.e., combined score is 250% to
`569% .
`
`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 have a higher potential for
`confiJsion and should be evaluated further (see Step 2).
`
`For single strength products, also consider circumstances where the strength may
`not be expressed.
`
`For any combination drug products, 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
`roduct, consider the followin ', list of factors that ma increase confusion:
`
`Reference ID: 3508318
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`10
`
`

`

`o 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.
`
`o
`
`o
`
`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 these
`questions suggest that the pattern of orthographic or phonetic differences in the
`names may render the names less likely to confusion between moderately similar
`names with overlapping or similar strengths or doses.
`
`Reference ID: 3508318
`
`11
`
`

`

`Orthographic Checklist (Y/N to each
`question)
` Do the names begin with
`different first letters?
`
`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?
`
`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?
`
`Reference ID: 3508318
`
`12
`
`

`

`Table 5: Low Similari Name Pair Checklist
`
`i.e., combined score is 549% .
`
`similar name nair checklist.
`
`In most circumstances, these names are viewed as sufficiently different to minimize
`confusion. Exceptions to this would occur in circumstances where there are data that
`suggest a name with low similarity might be vulnerable to confusion with your
`proposed name (for example, misinterpretation of the proposed name as a marketed
`product in a prescription simulation study). In such instances, FDA would reassign a
`low similarity name to the moderate similarity category and review according to the
`moderate]
`
`Appendix B: Prescription Simulation Samples and Results
`
`Figure l. Namzaric Study {Conducted on March 143 20141
`
`Handwritten Re . uisition Medication Order
`
`Verbal Prescri - tion
`
`Namzaric 28/ 10
`
`One po daily
`
`#30
`
`0'” ["6 {M 4+3”
`
`Medication Order:
`
`I
`
`Climatient Prescription:
`
`Reference ID: 3508318
`
`13
`
`

`

`FDA Prescription Simulation Responses (Aggregate 1 Rx Studies Report!
`Study Name: Namzaric
`Conducted: 3/ 14/2014
`
`Study Name: Namzalic
`Total
`
`40
`
`34
`
`40
`
`274 People Received Study
`114 People Responded
`
`
`
`INPATIENT
`
`TOTAL
`
`INTERPRETATION
`
`OI’TPATIENT
`
`VOICE
`
`COMBO DRUG
`
`NADSERIC
`
`NAMARIC
`
`NAMBERIC 28-10
`
`NAMRARIC
`
`NAMRARIC 28/10
`
`NAMSANI
`
`NAMVERIC
`
`NAMVERICK
`
`NAMVERICK 28/ 10
`
`NAMZANI
`
`1
`
`0
`
`1
`
`0
`
`12
`
`3
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`1
`
`0
`
`1
`
`0
`
`0
`
`0
`
`2
`
`4
`
`1
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`1
`
`0
`
`0
`
`0
`
`27
`
`2
`
`l
`
`l
`
`1
`
`l
`
`12
`
`3
`
`1
`
`2
`
`4
`
`1
`
`27
`
`2
`
`NAMZANI 14/10
`
`NAMZARI
`
`NAMZARI 14/10
`
`NAMZARIA
`
`NAMZARIC
`
`NAMZARIC 28/ 10
`
`NAMZARIE 28/10
`
`NAMZARIK
`
`NAMZARIQ
`
`NAMZERECK 28/ 10
`
`NAMZEREK
`
`NAMZERIC
`
`NAMZERIC 28/10
`
`NAMZERIK 28/10
`
`0
`
`0
`
`0
`
`1
`
`19
`
`1
`
`1
`
`0
`
`0
`
`0
`
`0
`
`1
`
`0
`
`0
`
`0
`
`0
`
`0
`
`1
`
`0
`
`0
`
`l
`
`1
`
`1
`
`1
`
`3
`
`1
`
`1
`
`1
`
`1
`
`0
`
`1
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`1
`
`l
`
`l
`
`21
`
`1
`
`l
`
`1
`
`1
`
`l
`
`l
`
`4
`
`l
`
`1
`
`Reference ID: 3508318
`
`14
`
`

`

`NANZARIC
`
`NANZERIC
`
`NENIBSERIC 28/10
`
`NEMVERIC
`
`NEMVERIC 28-10
`
`NEMZARIC
`
`NEMZARIK
`
`NEMZERIC
`
`NENZARIC
`
`NIMVERIC
`
`NUMZANI
`
`GOOOQCOOCOGO
`
`oc._._.;;.—.—-.—.—.—-NN
`
`NMOOOOOGOGOG
`
`NUIHi-‘A—‘t-Iv—Ht—NN
`
`NUMZANI 14/ 10
`
`
`Reference ID: 3508318
`
`15
`
`

`

`Angendix C: Highly Similar Names (i.e., combined POCA score is 270%)
`
`Proposed name: Namzaric
`
`memantine/donepezil HCl
`
`Score (%)
`
`Orthographic and/or phonetic differences in the
`names sufficient to prevent confusion
`
`dail _ alternate 01‘0 .osed name for r0 osed name Namzaric
`
`Strength(s): 14mg /10 mg and
`28 mg/lo mg
`
`Usual Dose: One capsule
`
`Appendix D: Moderately Similar Names (i.e., combined POCA score is 250% to 569%)
`with no overlap or numerical similarity in Strength and/or Dose
`
`Score %
`
`POCA
`a ProposedName
`I—win“
`__
`wow u
`
`Hm-
`
`
`
` Gammar I.V. 56
`
`NEVANAC
`
`56
`
`il—-
`_-
`
`Reference ID: 3508318
`
`16
`
`

`

`14.
`
`15.
`
`16.
`
`17.
`
`18.
`
`19.
`
`20.
`
`21.
`
`22.
`
`23.
`
`24.
`
`25.
`
`26.
`
`27.
`
`28.
`
`29.
`
`30.
`
`***
`
`Nasabid
`
`Natpara***
`
`Romilar AC
`
`***
`
`Ny-Tannic
`
`Amvisc
`
`benzac
`
`Dandrex
`
`***
`
`maraviroc
`
`Nafarelin
`
`NAFAZAIR
`
`Natafort
`
`NATRECOR
`
`Novagesic
`
`NYDRAZID
`
`31.
`Gammagard
`32. MYFORTIC
`33.
`Panlor DC
`
`34.
`
`35.
`
`36.
`
`37.
`
`Americet
`
`DENDRID
`
`Nonbac
`
`NORGESIC
`
`54
`
`54
`
`54
`
`54
`
`53
`
`53
`
`52
`
`52
`
`52
`
`52
`
`52
`
`52
`
`52
`
`52
`
`52
`
`52
`
`52
`
`51
`
`51
`
`51
`
`50
`
`50
`
`50
`
`50
`
`Reference ID: 3508318
`
`17
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`
`
`Nyamyc
`
`
`
`Appendix E: Moderately Similar Names (i.e., combined POCA score is 250% to 569%)
`with overlap or numerical similarity in Strength and/or Dose
`
`Proposed name: Namzaric
`
`POCA Prevention of Failure Mode
`
`(Memantine/Donepezil) capsule
`
`Strength(s): l4 mg/10 mg and
`28mgl10 mg
`Usual Dose' The usual dosage is
`28 mg/l0 mg once daily. The
`maximum daily dose is 28
`
`mg/10 mg. For patients with
`severe renal impairment a dose
`of 14/10 mg once daily is
`recommended.
`
`In the conditions outlined below, the following
`combination of factors, are expected to minimize the
`risk of confusion between these two names
`
`
`_-
`
`1.
`
`ABSORICA
`
`54
`
`There are Oithographic differences, as there can be a
`downstroke ‘z’ in Namzaiic and an upstroke ‘b’ in
`Absorica. There are phonetic differences (4 vs. 3
`s llables and different sound for the first s llable.
`
`Appendix F: Low Similarity Names (i.e., combined POCA score is S 49%)
`
`Score %
`
`5._-
`
`Reference ID: 3508318
`
`18
`
`

`

`Appendix G: Names not likely to be confused or not used in usual practice settings for
`the reasons described.
`
`Failure preventions
`
`Name identified in RxNorm
`
`database. Unable to find
`
`product characteristics in
`commonly used drug
`databases.
`
`
`
`Name identified in POCA
`
`database Name Entered by
`Safety Evaluator. Unable to
`find product characteristics
`in commonly used drug
`databases.
`
`Name identified in RxNorm
`
`database. Unable to find
`
`product characteristics in
`commonly used drug
`databases.
`
`Name identified in RxNorm
`
`database. Unable to find
`
`product characteristics in
`commonly used drug
`databases.
`
`Name identified in POCA in
`
`Name Entered by Safety
`Evaluator database. Unable
`
`to find product
`characteristics in commonly
`used dru databases.
`
`Name identified in RxNorm
`
`database. Unable to find
`
`product characteristics in
`commonly used drug
`databases.
`
`8::
`
`This document contains proprietary and confidential information that should not be released to the
`public
`
`Reference ID: 3508318
`
`19
`
`

`

`7.
`
`8.
`
`9.
`
`Synalar-C
`
`Syntaris
`
`Daktarin
`
`10.
`
`Nadroparin
`
`11.
`
`Natrilix
`
`12.
`
`Numotac
`
`13.
`
`Camphor Ice
`
`14. Marfarin
`
`15.
`
`benzarone
`
`54
`
`54
`
`52
`
`52
`
`52
`
`52
`
`51
`
`51
`
`50
`
`Name identified in RxNorm
`database. Unable to find
`product characteristics in
`commonly used drug
`databases.
`Name identified in RxNorm
`database. Unable to find
`product characteristics in
`commonly used drug
`databases.
`Name identified in RxNorm
`database. Unable to find
`product characteristics in
`commonly used drug
`databases.
`Name identified in RxNorm
`database. Unable to find
`product characteristics in
`commonly used drug
`databases.
`Name identified in RxNorm
`database. Unable to find
`product characteristics in
`commonly used drug
`databases.
`Name identified in RxNorm
`database. Unable to find
`product characteristics in
`commonly used drug
`databases.
`Name identified in RxNorm
`database. Unable to find
`product characteristics in
`commonly used drug
`databases.
`Name identified RxNorm
`database. Unable to find
`product characteristics in
`commonly used drug
`databases.
`Name identified in RxNorm
`database. Unable to find
`
`Reference ID: 3508318
`
`20
`
`

`

`16.
`
`Dixarit
`
`17.
`
`Invarest
`
`18. Mianserin
`
`19.
`
`Nalex AC
`
`20.
`
`***
`
`21.
`
`NexGard
`
`22.
`
`***
`
`50
`
`50
`
`50
`
`50
`
`50
`
`50
`
`50
`
`product characteristics in
`commonly used drug
`databases.
`Name identified in RxNorm
`database. Unable to find
`product characteristics in
`commonly used drug
`databases.
`Name identified in RxNorm
`database. Unable to find
`product characteristics in
`commonly used drug
`databases.
`Name identified in RxNorm
`database. Unable to find
`product characteristics in
`commonly used drug
`databases.
`Name identified in RxNorm
`database. Unable to find
`complete product
`characteristics in commonly
`used drug databases.
`This is a secondar