CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`206073Orig1s000
`
`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:
`May 7, 2014
`Application Type and Number: NDA 206073
`Product Name and Strength:
`Glyxambi (empagliflozin and linagliptin) 10 mg/5 mg;
`25 mg/5 mg
`Multi-ingredient
`Rx
`Boehringer Ingelheim Pharmaceuticals, Inc
`March 13, 2014
`2014-17094
`Mishale Mistry, PharmD, MPH
`Yelena Maslov, PharmD
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Submission Date:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Team Leader:
`
`
`
`Reference ID: 3502894
`
`

`

`
`
`1
`
`2
`
`Contents
`INTRODUCTION ........................................................................................................... 1
`1.1
`Product Information ............................................................................................. 1
`RESULTS ....................................................................................................................... 2
`2.1
`Promotional Assessment ...................................................................................... 2
`2.2
`Safety Assessment ................................................................................................ 2
`CONCLUSIONS.............................................................................................................. 3
`3.1
`Comments to the Applicant ................................................................................. 4
`REFERENCES ................................................................................................................. 4
`4
`APPENDICES ........................................................................................................................ 5
`
`3
`
`
`
`
`
`
`Reference ID: 3502894
`
`

`

`
`
`1
`INTRODUCTION
`This review evaluates the proposed proprietary name, Glyxambi, 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
`did not submit an external name study for this proposed proprietary name.
`
`1.1
`PRODUCT INFORMATION
`The following product information is provided in the March 13, 2014 proprietary name
`submission and January 30, 2014 Original NDA submission.
`•
`Intended Pronunciation: glik-SAM-bee
`• Active Ingredient: empagliflozin and linagliptin
`•
`Indication of Use: Adjunct to diet and exercise to improve glycemic control in
`adults with type II diabetes mellitus when treatment with both empagliflozin and
`linagliptin is appropriate.
`• Route of Administration: Oral
`• Dosage Form: Oral fixed-dose combination (FDC) tablets
`• Strength: 10 mg empagliflozin/5 mg linagliptin, 25 mg empagliflozin/5 mg
`linagliptin
`• Dose and Frequency: Recommended starting dose is 10 mg empagliflozin/5 mg
`linagliptin once daily. Dose can be increased to 25 mg empagliflozin/5 mg
`linagliptin once daily in patients who require additional control.
`• How Supplied:
`- 10 mg/5 mg tablets: Pale yellow, arc triangular, flat-faced, bevel-edged,
`film-coated tablets. One side is debossed with the Boehringer Ingelheim
`company symbol; the other side is debossed with “10/5”. Bottles of 30-
`count, 90-count, 1000-count, 30-tablet institutional pack, 7-tablet
`professional sample bottle.
`- 25 mg/5 mg tablets: Pale pink, arc triangular, flat-faced, bevel-edged,
`film-coated tablets. One side is debossed with the Boehringer Ingelheim
`company symbol; the other side is debossed with “25/5”. Bottles of 30-
`count, 90-count, 1000-count, 30-tablet institutional pack, 7-tablet
`professional sample bottle.
`• Storage: Store at 25°C (77 °F); excursions permitted to 15°C - 30°C (59°F-86 °F).
`Store in a safe place out of reach of children.
`• Container and Closure Systems:
`
`Reference ID: 3502894
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`
`1
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`

`

`
`
`- Multidose high density polyethylene (HDPE) bottle (60 cc and 375 cc),
`closed with a two piece
` closure with an induction seal
`liner
`- Blister card consists of an aluminum lidding foil
`
`
`
`
`
`2 RESULTS
`The following sections provide information obtained and considered in the overall
`evaluation of the proposed proprietary name.
`
`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 Metabolism and
`Endocrinology (DMEP) 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 name1.
`
`2.2.2 Components of the Proposed Proprietary Name
`The Applicant did not provide a derivation or intended meaning for the proposed name,
`Glyxambi 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 FDA Name Simulation Studies
`110 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. Fifty-
`nine participants interpreted the name correctly (outpatient n=31, voice n=6, inpatient
`n=22). Four participants misinterpreted the capital letter ‘G’; 2 for an ‘L’ (voice n=2) and
`1 for an ‘M’ (outpatient n=2). Twenty-one participants misinterpreted the syllable ‘Glyx’
`in the voice prescription study; 19 for ‘Glix’ and two for ‘Glic’. Thirty-one participants
`misinterpreted the letter string ‘bi’; 9 for ‘bo’ (inpatient n=9), 8 for ‘by’ (voice n=8), 3 for
`‘be’ (voice n=3), 3 for ‘bie’ (voice n=3), 2 for ‘ba’ (inpatient n=2), 2 for ‘bic’ (outpatient
`n=2), 1 for ‘bu’ (outpatient n=1), 1 for ‘mi’ (inpatient n=1), 1 for ‘so’ (inpatient n=1), and
`
`
`1USAN stem search conducted on March 20, 2014.
`
`Reference ID: 3502894
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`
`2
`
`(b) (4)
`
`(b) (4)
`
`

`

`1 for 'ta’ (inpatient n=1). 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 31, 2014 e-mail, the Division of Metabolism and
`
`Endocrinology Products (DMEP) did not forward any comments or concerns relating to
`
`the proposed proprietary name at the initial phase of the review.
`
`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 250% retrieved from our POCA search organized as highly similar, moderately similar
`
`or low similarity for further evaluation.
`
`Table 1. POCA Search Results
`
`Number of
`
`Names
`
`Highly similar name pair.
`
`combined match percentage score >70%
`
`
`
`Moderately similar name pair.
`
`combined match percentage score 250% to S 69%
`
`Low similarity name pair:
`
`combined match percentage score 549%
`
`2.2.6 Safety Analysis of Names with Potential Orthographic, Spelling, and Phonetic
`Similarities
`
`Our analysis of the 23 names contained in Table 1 determined that none of the names
`
`will pose a risk for confusion as described in Appendices C through E.
`
`2.2.7 Communication of DMEPA’s Analysis at Midpoint of Review
`
`DMEPA communicated our findings to the Division of Metabolism and Endocrinology
`
`Products (DMEP) via e-mail on April 23, 2014. At that time we also requested additional
`
`information or concerns that could inform our review. Per e-mail correspondence from
`
`the DMEP on April 29, 2014, they stated no additional concerns with the proposed
`
`proprietary name, Glyxambi.
`
`3
`
`CONCLUSIONS
`
`The proposed proprietary name is acceptable from both a promotional and safety
`
`perspective.
`
`If you have further questions or need clarifications, please contact Lyle Canida, OSE
`
`project manager, at 301-796-1637.
`
`Reference ID: 3502894
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`

`

`
`
`3.1
`COMMENTS TO THE APPLICANT
`We have completed our review of the proposed proprietary name, Glyxambi, and have
`concluded that this name is acceptable.
`If any of the proposed product characteristics as stated in your March 13, 2014
`submission are altered, the name must be resubmitted for review.
`
`4 REFERENCES
`
`1. USAN Stems (http://www.ama-assn.org/ama/pub/physician-resources/medical-
`science/united-states-adopted-names-council/naming-guidelines/approved-
`stems.page)
`USAN Stems List contains all the recognized USAN stems.
`
`2. Phonetic and Orthographic Computer Analysis (POCA)
`POCA is a system that FDA designed. As part of the name similarity assessment, POCA is
`used to evaluate proposed names via a phonetic and orthographic algorithm. The
`proposed proprietary name is converted into its phonemic representation before it runs
`through the phonetic algorithm. Likewise, an orthographic algorithm exists that
`operates in a similar fashion. POCA is publicly accessible.
`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#).
`
`Reference ID: 3502894
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`
`4
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`

`

`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.
`
`APPENDICES
`
`Aggendix 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, so as 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 DM EPA 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. 2
`
`*Table 2. Prescreening Checklist for Proposed Proprietary Name
`
`Affirmative answers to these questions indicate a potential
`area of concern.
`
`other Names? Does the name have obvious Similarities in Spelling and Pronunciation to
`
`2 National Coordinating Council for Medication Error Reporting and Prevention.
`
`htt : www.nccmer .or aboutMedErrors.html. Last accessed 10/11/2007.
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`Reference ID: 3502894
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`

`

`
`
`Y/N
`
`Are there Manufacturing Characteristics in the Proprietary Name?
`
`Are there Medical and/or Coined Abbreviations in the Proprietary Name?
`
`Are there Inert or Inactive Ingredients referenced in the Proprietary Name?
`
`Is this a Proprietary Name of a discontinued product?
`
`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
`
`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 50% threshold in POCA. DMEPA reviews the combined orthographic and
`
`phonetic matches and group the names into one of the following three categories:
`
`0 Highly similar pair: combined match percentage score 270%.
`
`0 Moderately similar pair: combined match percentage score 250% to S 69%.
`
`0
`
`Low similarity: combined match percentage score 349%.
`
`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. 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.).
`
`o
`
`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)
`
`o 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
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`Reference ID: 3502894
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`

`

`
`
`review these 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 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.
`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.
`
`Reference ID: 3502894
`
`
`7
`
`

`

`
`
`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 do not
`share a common strength or dose (see Step 1 of the Moderately Similar Checklist).
`
`
`
`Orthographic Checklist
`
`
`
`
`
`
`
`
`
`
`
`
`Y/N
`
`
`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
`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?
`
`
`Y/N
`
`Is there different number or
`placement of cross-stroke or
`dotted letters present in the
`names?
`
`Reference ID: 3502894
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`
`
`Phonetic Checklist
`
`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?
`
`
`Y/N
`
`
`Y/N
`
`
`Y/N
`
`
`Y/N
`
`
`
`
`
`
`
`
`
`8
`
`

`

`
`
`
`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%).
`
`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 confusion 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.
`
`moderate similarity.
`
`To determine whether the strengths or doses are similar to your proposed
`
`product, consider the following list of factors that may increase confusion:
`
`0 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
`
`Similar sounding doses: 15 mg is similar in sound to 50 mg
`
`Reference ID: 3502894
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`

`

`
`
`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.
`Orthographic Checklist (Y/N to each
`Phonetic Checklist (Y/N to each
`question)
`question)
`• Do the names begin with
`• Do the names have different
`different first letters?
`number of syllables?
`
`
`• Do the names have different
`Note that even when names begin
`syllabic stresses?
`with different first letters, certain
`
`letters may be confused with each
`other when scripted.
`
`
`• Do the syllables have different
`• Are the lengths of the names
`phonologic processes, such
`dissimilar* when scripted?
`vowel reduction, assimilation,
`or deletion?
`
`• Across a range of dialects, are
`the names consistently
`pronounced differently?
`
`
`
`*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: 3502894
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`
`10
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`

`

`Table 5: Low Similarity Name Pair Checklist (i.e., combined score is 549%).
`
`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
`
`moderately similar name pair checklist.
`
`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
`
`Appendix B: Prescription Simulation Samples and Results
`
`Fi ure 1. GI
`
`ambi Stud Conducted on March 28 2014
`
`Out atient Prescri
`
`Handwritten Requisition Medication Order
`
`Verbal Prescription
`
`Medication Order:
`
`Glyxambi 10 mg
`
`1 tablet orally once daily
`
`tion:
`
`FDA Prescription Simulation Responses {Aggregate 1 Rx Studies Report!
`
`
`
`276 People Received Study
`
`110 People Responded
`
`
`Study Name: Glyxambi
`
`
`Total
`
`
`
`VOICE OUTPATIENT
`INPATIENT
`TOTAL
`INTERPRETATION
`
` GIPSAMBE
`
`
`GLADZABY
`
`
`
`Reference ID: 3502894
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`11
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`

`

`INTERPRETATION
`
`OUTPATIENT
`
`VOICE
`
`INPATIENT
`
`TOTAL
`
`GLICKSAMBI
`
`GLICSAMBY
`
`GLIXAMBE
`
`GLIXAMBI
`
`GLIXAMBIE
`
`GLIXAMBY
`
`GLIXSAMBI
`
`GLIXSAMBY
`
`GLXAMBY
`
`GLYAXAMBI
`
`GLYXABI
`
`GLYXAMBA
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`1
`
`0
`
`1
`
`1
`
`2
`
`9
`
`2
`
`3
`
`2
`
`1
`
`1
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`1
`
`0
`
`2
`
`22
`
`1
`
`1
`
`2
`
`9
`
`2
`
`3
`
`2
`
`1
`
`1
`
`1
`
`1
`
`2
`
`59
`
`
`
`GLYXAMBI
`
`31
`
`GLYXAMBIC
`
`GLYXAMBIE
`
`GLYXAMBO
`
`GLYXAMBY
`
`GLYXAMI
`
`GLYXAMSO
`
`GLYXANBU
`
`GLYXANTA
`
`GLYXSAMBI
`
`LEXAMBI
`
`LIXZEMBI
`
`MLYXAMBI
`
`2
`
`0
`
`0
`
`0
`
`0
`
`0
`
`1
`
`0
`
`0
`
`0
`
`0
`
`2
`
`6
`
`0
`
`1
`
`0
`
`1
`
`0
`
`0
`
`0
`
`0
`
`2
`
`1
`
`1
`
`0
`
`0
`
`0
`
`9
`
`0
`
`1
`
`1
`
`0
`
`1
`
`0
`
`0
`
`0
`
`0
`
`
`
`2
`
`1
`
`9
`
`1
`
`1
`
`1
`
`1
`
`1
`
`2
`
`1
`
`1
`
`2
`
`Reference ID: 3502894
`
`12
`
`

`

`Appendix C: Moderately Similar Names (i.e., combined POCA score is 250% to 569%)
`
`with no overlap or numerical similarity in Strength and/or Dose
`
`
`
`Appendix D: Moderately Similar Names (i.e., combined POCA score is 250% to 569%)
`
`with overlap or numerical similarity in Strength and/or Dose
`
`Proposed name: Glyxambi
`Strength(s):
`
`POCA
`Score (,6)
`
`10
`
`l'fl
`' 5
`mg empag l ozm/ mg
`linagliptin
`
`25 mg empagliflozin/5 mg
`
`linagliptin
`
`Usual Dose: 1 tablet orally
`
`once daily
`
`Gly—Oxide
`
`Prevention of Failure Mode
`In the conditions outlined below, the following
`combination of factors, are expected to minimize the
`risk of confusion between these two names
`
`The infixes and suffixes of the names have sufficient
`
`orthographic and phonetic differences to minimize
`
`confusion: ’xambi’ does not appear similar to
`
`'oxide’ when scripted or spoken.
`
`
`
`Glucamide
`
`The infixes and suffixes of the names have sufficient
`
`Glycerin
`
`orthographic and phonetic differences to minimize
`
`confusion: ’xambi’ does not appear similar to
`
`'camide’ when scripted or spoken.
`
`Glyxambi has a downstroke letter, which is absent
`in Glucamide.
`
`The infixes and suffixes of the names have sufficient
`
`orthographic and phonetic differences to minimize
`
`confusion: ’xambi’ does not appear similar to ’cerin’
`
`when scripted or spoken.
`
`Glyxambi has an additional upstroke letter placed at
`
`the end of the name, which is absent in Glycerin.
`
`Glutamic—SOO
`
`The infixes and suffixes of the names have sufficient
`
`orthographic and phonetic differences to minimize
`
`confusion: ’xambi’ does not appear similar to
`
`Reference ID: 3502894
`
`13
`
`

`

`Proposed name: Glyxambi
`
`POCA
`
`Prevention of Failure Mode
`
`Strength(s):
`
`In the conditions outlined below, the following
`
`combination of factors, are expected to minimize the
`risk of confusion between these two names
`
`10 mg empagliflozin/S mg
`
`linagliptin
`
`25 mg empagliflozin/5 mg
`
`linagliptin
`
`Usual Dose: 1 tablet orally
`
`once daily
`
`Glauctabs
`
`The suffixes of the names have sufficient
`
`’tamic’ when scripted or spoken.
`
`Glyxambi has a downstroke letter, which is absent
`in GIutamic—SOO.
`
`Glucovance
`
`orthographic and phonetic differences to minimize
`
`confusion: 'bi’ does not appear similar to ’tabs’
`
`when scripted or spoken.
`
`Glyxambi has a downstroke letter, which is absent
`in Glauctabs.
`
`In terms of phonetic differences, Glyxambi has
`
`three syllables whereas Glauctabs has two syllables.
`
`The lengths of the names differ by two letters.
`
`The infixes and suffixes of the names have sufficient
`
`orthographic and phonetic differences to minimize
`
`confusion: 'xambi’ does not appear similar to
`
`'covance' when scripted or spoken.
`
`Glyxambi has a downstroke letter and two
`
`
`
`
`additional upstroke letters, which is absent in
`Glucovance.
`
`Glucosamine
`
`The lengths of the names differ by three letters.
`
`The suffixes of the names have sufficient
`
`orthographic and phonetic differences to minimize
`
`confusion: 'bi’ does not appear similar to lmine’
`
`when scripted or spoken.
`
`Glyxambi has a downstroke letter, which is absent
`in Glucosamine.
`
`In terms of phonetic differences, Glyxambi has
`
`three syllables whereas Glucosamine has four
`
`Reference ID: 3502894
`
`14
`
`

`

`Proposed name: Glyxambi
`
`POCA
`
`Prevention of Failure Mode
`
`Score (96)
`
`In the conditions outlined below, the following
`
`combination of factors, are expected to minimize the
`risk of confusion between these two names
`
`Strength(s):
`
`10 mg empagliflozin/S mg
`
`linagliptin
`
`25 mg empagliflozin/S mg
`
`linagliptin
`
`Usual Dose: 1 tablet orally
`
`m“)
`
`
`once daily
`— syllables-
`
`Glutamine
`
`o The suffixes of the names have sufficient
`
`Glycotuss-DM
`
`orthographic and phonetic differences to minimize
`
`confusion: ’bi’ does not appear similar to ’mine’
`
`when scripted or spoken.
`
`Glyxambi has a downstroke letter, which is absent
`in Glutamine.
`
`The infixes and suffixes of the names have sufficient
`
`orthographic and phonetic differences to minimize
`
`confusion: ’xambi’ does not appear similar to
`
`’cotuss’ when scripted or spoken.
`
`Glycotuss-DM has an additional upstroke letter,
`
`located in the middle of the name, which is absent
`
`in Glyxambi.
`
`The infixes and suffixes of the names have sufficient
`
`orthographic and phonetic differences to minimize
`confusion:
`
`Appendix E: Names not likely to be confused or not used in usual practice settings for
`the reasons described.
`
`Score (96)
`
`Failure Preventions
`
`POCA
`
`Reference ID: 3502894
`
`15
`
`

`

`POCA
`
`Score (96)
`
`Failure Preventions
`
`Glyoxal
`
`57%
`
`Name identified in RxNorm database. Unable to find
`
`product characteristics in commonly used drug
`databases.
`
`(mo
`
`56%
`
`This is a secondary proposed proprietary name. Both
`
`
`
`Glucamet
`
`Glucamine
`
`H0
`
`H H
`
`H N
`
`primary and secondary proposed names were
`withdrawn by the applicant
`mm).
`
`International product marketed in Finland, Hong Kong,
`
`Malaysia, Thailand, New Zealand, Ireland, Netherlands,
`
`Denmark, Sweden, Singapore, Portugal, UK.
`
`Proposed Proprietary Name found unacceptable by
`DMEPA (
`W"
`
`International product marketed in UK.
`
`Name identified in RxNorm database. Unable to find
`
`product characteristics in commonly used drug
`databases.
`
`Name entered by Safety Evaluator. Unable to find
`
`name in AlMS/Panorama/LzDrive (no Application #1).
`
`Proposed Proprietary Name found unacceptable by
`DMEPA
`(b)(4))_ Product is considered to be
`on inactive status.
`
`This is a secondary proposed proprietary name and
`
`DMEPA found the primary proposed name
`unacceptable 1
`(m0). Product received
`Complete Response and NBA was not resubmitted.
`
`Reference ID: 3502894
`
`16
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`MISHALE P MISTRY
`05/07/2014
`
`YELENA L MASLOV
`05/07/2014
`
`Reference ID: 3502894
`
`