CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`203567Orig1s000
`
`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:
`March 26, 2014
`Application Type and Number: NDA 203567
`Product Name and Strength:
`Jublia (Efinaconazole) Topical Solution, 10%
`Product Type:
`Single-ingredient Product
`Rx or OTC:
`Rx
`Applicant/Sponsor Name:
`Dow Pharmaceutical Sciences
`Submission Date:
`February 4, 2014
`Panorama #:
`2014-16885
`DMEPA Primary Reviewer:
`Carlos M Mena-Grillasca, RPh
`DMEPA Team Leader:
`Lubna Merchant, MS, PharmD
`
`Reference ID: 3477452
`
`

`

`1
`
`Contents
`INTRODUCTION ........................................................................................................... 1
`1.1
`Regulatory History................................................................................................ 1
`1.2
`Product Information............................................................................................. 1
`RESULTS ....................................................................................................................... 1
`2.1
`Promotional Assessment...................................................................................... 1
`2.2
`Safety Assessment................................................................................................ 2
`CONCLUSIONS.............................................................................................................. 3
`3.1
`Comments to the Applicant ................................................................................. 3
`REFERENCES................................................................................................................. 4
`4
`APPENDICES ........................................................................................................................ 5
`
`2
`
`3
`
`Reference ID: 3477452
`
`

`

`INTRODUCTION
`1
`This review evaluates the proposed proprietary name, Jublia, 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.
`
`REGULATORY HISTORY
`1.1
`The proposed proprietary name Jublia was found conditionally acceptable during first
`review cycle of the NDA in OSE review 2013-240, dated April 12, 2013.
`
`PRODUCT INFORMATION
`1.2
`The following product information is provided in the 2/4/2014 proprietary name
`submission.
`Intended Pronunciation: Joob lee’ ah
`
` Active Ingredient: Efinaconazole
`Indication of Use: Onychomycosis
`
` Route of Administration: Topical
` Dosage Form: Solution
`Strength: 10%
`
` Dose and Frequency: Apply to the affected toenail(s) once daily
` How Supplied: 4 ml and 8 mL bottles
`Storage: 25°C (77°F); excursions permitted to 15-30 (59-86°F)
`
` Container and Closure Systems: HDPE bottles containing
`plug with
` brush and
` cap
`
` inside
`
`RESULTS
`2
`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 Dermatology
`and Dental Products (DDDP) concurred with the findings of OPDP’s promotional
`assessment of the proposed name.
`
`Reference ID: 3477452
`
`1
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`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,
`Jublia 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
`One hundred fifty-seven 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. Thirty-six participants interpreted the name correctly
`(outpatient n=4, voice n=6, inpatient n=26). A total of 103 participants misinterpreted
`the capital letter ‘J’; 27 for an ‘L’ (outpatient n=21, inpatient n=6), 23 for an ‘S’
`(outpatient n=21, voice n=2), 21 for a ‘Ch’ (voice n=21), 14 for a ‘T’ (outpatient n=1,
`inpatient n=13), 12 for a ‘F’ (outpatient n=7, inpatient n=5), and 6 for a ‘G’ (voice n=6).
`(Appendix B contains the results from the verbal and written prescription studies.
`
`2.2.4 Comments from Other Review Disciplines at Initial Review
`In response to the OSE, February, 18, 2014 e-mail, the Division of Dermatology and
`Dental Products (DDDP) 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 ≥50% retrieved from our POCA search organized as highly similar, moderately similar
`or low similarity for further evaluation.
`
`
`1USAN stem search conducted on March 14, 2014.
`
`Reference ID: 3477452
`
`2
`
`

`

`Table 1. POCA Search Results
`
`Number of
`
`Highly similar name pair:
`
`combined match percentage score 270%
`
`combined match percentage score 549%
`
`Moderately similar name pair:
`
`combined match percentage score 250% to S 69%
`
`Low similarity name pair:
`
`2.2.6 Safety Analysis of Names with Potential Orthographic, Spelling, and Phonetic
`Similarities
`
`We note that none of the product characteristics other than the package size changed
`
`from our previous review. However, we considered the worst case scenario by
`assuming a quantity of #1. Therefore, three names previously evaluatgfldn OSE review
`2013-240, dated April 12, 2013 will not be re-evaluated (Januvia,
`"**, and
`
`Jetrea).
`
`Our analysis of the remaining 35 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 Dermatology and Dental Products
`
`(DDDP) via e-mail on March 19, 2014. At that time we also requested additional
`
`information or concerns that could inform our review. Per e-mail correspondence from
`
`the DDDP on March 25, 2014, they stated no additional concerns with the proposed
`
`proprietary name, Jublia.
`
`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 Teena Thomas, OSE
`
`project manager, at 301-796-0549.
`
`3.1
`
`COMMENTS TO THE APPLICANT
`
`We have completed our review of the proposed proprietary name, Jublia, and have
`
`concluded that this name is acceptable.
`
`If any of the proposed product characteristics as stated in your February 4, 2014
`
`submission are altered, the name must be resubmitted for review.
`
`Reference ID: 3477452
`
`

`

`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).
`
` contains the names of prescription and many OTC drugs available in the United
` includes generic and branded:
`
`States.
`
`
`
`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
`
`(http://www.nlm.nih.gov/research/umls/
`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: 3477452
`
`4
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`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, 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.
`
`Safety Assessment: The safety assessment is conducted by DMEPA, and includes
`
`the following:
`
`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.
`llflp://www nccmegg.orgZaboutMedErrors html. Last accessed 10/11/2007.
`
`Reference ID: 3477452
`
`

`

`
`
`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) Stern 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, DM EPA 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,
`(m4) 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%.
`
`- Moderately similar pair: combined match percentage score 250% to S 69%.
`
`0
`
`Low similarity: combined match percentage score 549%.
`
`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),
`
`DM EPA 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 close, 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
`
`Reference ID: 3477452
`
`

`

`mitigate confusion may be limited when the strength or dose overlaps. FDA will
`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: 3477452
`
`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
`
`Phonetic Checklist
`
`Y/N
`
`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?
`
`Is there different number or
`placement of cross-stroke or
`dotted letters present in the
`names?
`
`Reference ID: 3477452
`
`Y/N
`
`Do the names have
`different number of
`syllables?
`
`Y/N
`
`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
`
`8
`
`

`

`
`
`Do the infixes of the name
`
`appear dissimilar when
`
`scripted?
`
`scripted?
`
`Do the suffixes of the names
`
`appear dissimilar when
`
`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.
`
`
`
`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
`
`Reference ID: 3477452
`
`

`

`moderate similarity.
`
`o
`
`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.
`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
`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?
`
`Reference ID: 3477452
`
`10
`
`

`

` 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 ≤49%).
`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
`moderately similar name pair checklist.
`
`Reference ID: 3477452
`
`11
`
`

`

`Medication
`
`.
`
`7
`
`‘
`
`.
`
`:
`
`,
`
`Jublia
`UAD
`
`Agpendix B: Prescription Simulation Samples and Results
`
`Fi ure 1. Jublia Stud Conducted on Februa
`
`14 2014
`
`Handwritten Requisition Medication Order
`
`Verbal Prescription
`
`Qty. 1
`
`Reference ID: 3477452
`
`12
`
`

`

`FDA Prescription Simulation Responses (Aggregate 1 Rx Studies Report|
`
`As of Date 3/17/2014
`
`Study Name: Jublia
`
`Total
`
`56
`
`50
`
`51
`
`INTERPRETATION
`
`OUTPATIENT
`
`VOICE
`
`INPATIENT
`
`TOTAL
`
`275 People Received Study
`
`157 People Responded
`
`CHABLIA
`
`CHABLIYA
`
`CHEBLEA
`
`CHEBLIA
`
`CHIBLEA
`
`CHIBLEAH
`
`CHIBLIA
`
`CHIPLEA
`
`DON'T KNOW
`
`
`
`FABBIA
`
`FABLIA
`
`FABLIA #1
`
`FEIBLIA
`
`FUBLIA
`
`FUBLIN
`
`GIBLEA
`
`G | BLEEA
`
`GIBLIA
`
`GYBLIA
`
`Reference ID: 3477452
`
`13
`
`

`

`
`
`JABBIA
`
`JABELIA
`
`JABLEA
`
`JABLIA
`
`JEBLIA
`
`JIBLEYA
`
`JIBLIA
`
`JUBLIA
`
`JULBIA
`
`JUVLIA
`
`LABLIA
`
`LUBBIA
`
`1
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`4
`
`0
`
`0
`
`6
`
`1
`
`0
`
`1
`
`1
`
`3
`
`2
`
`1
`
`3
`
`6
`
`0
`
`1
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`26
`
`1
`
`0
`
`0
`
`0
`
`1
`
`1
`
`1
`
`3
`
`2
`
`1
`
`3
`
`36
`
`1
`
`1
`
`6
`
`1
`
`20
`
`LUBLIA
`
`SABBIA
`
`SABLIA
`
`SHEBLIA
`
`SUBLEA
`
`SUBLIA
`
`TABLIA
`
`TIBLIA
`
`TUBLIA
`
`UNKNOWN
`
`XUBLIA
`
`14
`
`1
`
`9
`
`0
`
`0
`
`1 1
`
`1
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`1
`
`1
`
`0
`
`0
`
`0
`
`0
`
`1
`
`1
`
`6
`
`0
`
`0
`
`0
`
`0
`
`0
`
`1
`
`1
`
`1 1
`
`0
`
`0
`
`1
`
`9
`
`1
`
`1
`
`1 1
`
`2
`
`1
`
`1 1
`
`1
`
`1
`
`
`
`0 1 0ZUBLIA 1
`
`
`
`
`
`
`
`Reference ID: 3477452
`
`14
`
`

`

`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 25000 to 569%)
`
`with overlap or numerical similarity in Strength and/or Dose
`
`Proposed name: Jublia
`
`Prevention of Failure Mode
`
`Strength(s): 10%
`
`Usual Dose: Apply to
`
`In the conditions outlined below, the following
`
`affected toenail(s) once daily
`
`combination of factors, are expected to minimize the
`risk of confusion between these two names
`
`
`
`
`Gynol I|
`
`(otc)
`
`Jenloga
`
`Dose: xx mg vs. apply to affected toenail(s) or UAD
`
`Orthographic: The capital letters and the infix of this
`
`name pair have sufficient orthographic differences
`
`Orthographic: The infixes of this name pair have
`
`sufficient orthographic differences.
`
`Dose: 1 applicatorful intravaginally vs. apply to
`
`affected toenail(s) or UAD
`
`Orthographic: The infixes and suffixes of this name
`
`pair have sufficient orthographic differences.
`
`Phonetic: The names have different number of
`
`syllables (3 vs. 2). The second and third syllables in
`
`Jublia sound different than the second syllable in
`
`Gynol.
`
`Dose: 1 tablet or xx mg vs. apply to affected toenail(s)
`or UAD
`
`Orthographic: The infixes and suffixes of this name
`
`pair have sufficient orthographic differences.
`
`Phonetic: The second and third syllables in Jublia sound
`
`different than the second syllable in Jenloga.
`
`Reference ID: 3477452
`
`15
`
`

`

`Proposed name: Jublia
`
`Prevention of Failure Mode
`
`Strengthls): 10%
`
`Usual Dose: Apply to
`
`In the conditions outlined below, the following
`
`affected toenail(s) once daily
`
`combination of factors, are expected to minimize the
`risk of confusion between these two names
`
`
`
`
`Junel 1/20
`
`Junel 1.5/30
`
`Quflora
`
`Sublimaze
`
`10.
`
`Suclear
`
`Tabloid
`
`2.
`
`Strength: Jublia is a single strength product vs. Junel is
`
`available in two strength with no overlapping strengths
`
`between the products
`
`Orthographic: The infixes and suffixes of this name
`
`pair have sufficient orthographic differences.
`
`Dose: 1 tablet or xx mg vs. apply to affected toenail(s)
`or UAD
`
`Orthographic: The capital letters and the suffixes of
`
`this name pair have sufficient orthographic differences.
`
`Orthographic: The sufixes of this name pair have
`
`sufficient orthographic differences.
`
`Dose: xx mg or xx mcg or xx mL vs. apply to affected
`
`toenail(s) or UAD
`
`Orthographic: The suffixes of this name pair have
`
`sufficient orthographic differences.
`
`Orthographic: The infixes of this name pair have
`
`sufficient orthographic differences.
`
`Dose: xx mg or xx mcg or xx mL vs. apply to affected
`
`toenail(s) or UAD
`
`Orthographic: The suffixes of this name pair have
`
`sufficient orthographic differences.
`
`Dose: xx tablets vs. apply to affected toenail(s) or UAD
`
`Orthographic: The suffixes of this name pair have
`
`sufficient orthographic differences.
`
`Reference ID: 3477452
`
`l6
`
`

`

`Appendix E: Names not likely to be confused or not used in usual practice settings for
`the reasons described.
`
`Score (96)
`
`Failure preventions
`
`ThisIs a secondary proposed proprietary name
`lb) (4)
`for IND
`(mm The proposed name
`8; was found conditionally acceptable in OSE
`.
`4
`(I!) (4)
`reVIew
`0”” dated
`
`This is a secondary proposed proprietary name
`for NDA
`(m4) and the product was approved
`under the proprietary name
`(m4)
`
`m“) withdrawn by
`Proposed name for NDA
`the applicant on
`M“). The product was
`approved under the proprietary name
`mm
`
`This is a secondary proposed proprietary name
`for IND
`M“) The product was approved
`under the proprietary name
`(m4) (NDA
`(m4)
`
`
`
`(m4) withdrawn by
`Proposed name for IND
`the applicant. The secondary name
`(”ml was
`
`found conditionally acceptable in OSE review
`(m4), dated
`(b)«)_ IND
`(m4) is
`inactive as of
`"m".
`
`M“) withdrawn
`Proposed name for ANDA
`M“). The product
`by the applicant on
`was approved under the proprietary name
`(m4)
`
`Proposed name for IND
`
`mmwithdrawn by
`(b) (4) k
`the applicant. The secondary name
`
`was found conditionally acceptable in OSE
`review
`(m4), dated
`(bm)_
`
`mm
`Proposed name for NDA
`withdrawn by
`“l. The product was
`the applicant on
`a"
`(m4)
`approved under the proprietary name
`
`Proposed name found unacceptable for AN DA
`mm The product was approved under the
`generic name.
`
`Reference ID: 3477452
`
`17
`
`

`

`22.
`
`23.
`
`24.
`
`25.
`
`26.
`
`27.
`
`28.
`
`29.
`
`POCA
`
`Score (96)
`
`Failure preventions
`
`This is a secondary proposed proprietary name
`for NBA
`(m4) The product was approved
`under the proprietary name
`(mm
`
`Proposed proprietary name found unacceptable
`for NBA
`"”“’ by OPDP in OSE review "’""
`, dated
`M“). The product was
`approved under the proprietary name
`(”(4).
`
`100
`
`Proposed proprietary name subject of this
`review.
`
`Proposed proprietary name found unacceptable
`for IND
`M"). The secondary name
`mm
`
`was found conditionally acceptable in OSE
`review
`(m4), dated
`m“).
`
`Proposed proprietary name found unacceptable
`for IND
`"’"" by OPDP in OSE review "”“’
`dated
`M“).
`
`Name identified in ’Name entered by safety
`evaluator’ database.
`
`Unable to find this name in any internal
`database.
`
`52
`
`Proposed proprietary name for IND
`
`(”M
`
`withdrawn by the applicant.
`
`Name identified in
`
`mm) database.
`
`Unable to find product characteristics in
`
`commonly used drug databases.
`
`
`
`30.
`
`Vagilia
`
`52
`
`Name identified in Drugs@FDA database.
`
`Unable to find product characteristics in
`
`commonly used drug databases.
`
`This is a secondary proposed proprietary name
`for NBA
`(m4) and the product was approved
`under the proprietary name
`(m4)
`
`Proposed proprietary name found unacceptable
`for NBA
`"M by OPDP in OSE review "”“’
`, dated
`m“). The product was
`
`(b) (4)
`
`approved under the proprietary name
`
`Reference ID: 3477452
`
`18
`
`

`

`Failure preventions
`
`(hm)
`
`Proposed proprietary name found unacceptable
`for NDA
`(am) in OSE review
`(m4), dated
`M“). The product was approved
`under the proprietary name
`mm
`
`This is a secondary proposed proprietary name
`for NDA
`(m4) and the product was approved
`under the proprietary name
`
`Reference ID: 3477452
`
`19
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`CARLOS M MENA-GRILLASCA
`03/26/2014
`
`LUBNA A MERCHANT
`03/26/2014
`
`Reference ID: 3477452
`
`

`

`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`Office of Medication Error Prevention and Risk Management
`
`
`
`Proprietary Name Review
`
`Date:
`
`April 12, 2013
`
`Reviewer:
`
`Team Leader:
`
`Division Director:
`
`Drug Name and Strength:
`
`Application Type/Number:
`Applicant/Sponsor:
`
`OSE RCM #:
`
`
`Carlos M Mena-Grillasca, RPh, Safety Evaluator
`Division of Medication Error Prevention and Analysis
`Lubna Merchant, MS, PharmD
`Division of Medication Error Prevention and Analysis
`Carol Holquist, RPh
`Division of Medication Error Prevention and Analysis
`Jublia (Efinaconazole)
`Topical Solution, 10%
`NDA 203567
`Dow Pharmaceutical Sciences, Inc.
`2013-240
`
`
`
`
`*** This document contains proprietary and confidential information that should not be released
`to the public.***
`
`
`
`Reference ID: 3292380
`
`

`

`CONTENTS
`
`1
`
`INTRODUCTION ................................................................................................................................1
`1.1
`Regulatory History ......................................................................................................................1
`1.2