CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`207620Orig1s000
`
`PROPRIETARY NAME REVIEW(S)
`
`
`
`
`
`

`

`PROPRIETARY NAME REVIEW MEMORANDUM
`Division of Medication Error Prevention and Analysis (DMEPA)
`Office of Medication Error Prevention and Risk Management (OMEPRM)
`Office of Surveillance and Epidemiology (OSE)
`Center for Drug Evaluation and Research (CDER)
`
`*** This document contains proprietary information that cannot be released to the
`public***
`
`Date of This Review:
`Application Type and
`Number:
`Product Name and Strength:
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Submission Date:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Team Leader:
`
`June 11, 2015
`NDA 207620
`
`Entresto (sacubitril/valsartan) Tablets,
`24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg
`Multi-Ingredient Product
`Rx
`Novartis Pharmaceuticals Corporation
`April 24, 2015
`2015-47393-1
`Janine Stewart, PharmD
`Chi-Ming (Alice) Tu, PharmD
`
`Reference ID: 3778132
`
`1
`
`

`

`INTRODUCTION
`1
`This memorandum is to re-assess the proposed proprietary name, Entresto, which was
`previously found acceptable in OSE Review #2014-25640, dated November 17, 2014
`under IND 1046281; and in OSE Review #2015-47393, dated January 28, 2015 under
`
`NDA 207620.2 We note that there is
` 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg) since our last review.
`All other product characteristics remain the same.
`
`2 METHODS AND DISCUSSION
`For re-assessment of the proposed proprietary name, DMEPA conducted a gap analysis
`and searched the POCA database to identify names with orthographic and phonetic
`similarity to the proposed name that have been approved since the previous OSE
`proprietary name review #2014-25640. Additionally, we evaluated the previously
`identified names of concern considering any lessons learned from recent post-
`marketing experience, which may altered our previous conclusion regarding the
`acceptability of the proposed proprietary name. We also evaluated previously
`identified names taking into account the change in strength, dose, and frequency. Our
`evaluation has not altered our previous conclusion regarding the acceptability of the
`proposed proprietary name. Additionally, our POCA search did not identify any new
`names that represent a potential source of drug name confusion. As a result, we
`maintain that the name is acceptable.
`
`Additionally, DMEPA searched the USAN stem list to determine if the name contains any
`USAN stems as of the last USAN updates. The May 22, 2015 search of USAN stems did
`not find any USAN stems in the proposed proprietary name.
`
`CONCLUSIONS
`3
`DMEPA maintains the proposed proprietary name, Entresto, is acceptable from both a
`promotional and safety perspective under NDA 207620.
`If you have further questions or need clarifications, please contact Darrell Lyons, OSE
`Project Manager, at 301-796-4092.
`
`
`1 Gao T. Proprietary Name Review for Entresto (IND 104628). Silver Spring (MD): Food and Drug
`Administration, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology,
`Division of Medication Error Prevention and Analysis (US); 20141117. 36 p. OSE RCM No.: 2014-25640.
`
`2 Stewart J. Proprietary Name Review Memo for Entresto (NDA 207620). Silver Spring (MD): Food and
`Drug Administration, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology,
`Division of Medication Error Prevention and Analysis (US); 20150128. 2 p. OSE RCM No.: 2015-47393.
`
`Reference ID: 3778132
`
`2
`
`(b) (4)
`
`

`

`COMMENTS TO THE APPLICANT
`4
`We have completed our review of the proposed proprietary name, Entresto, and have
`concluded that this name is acceptable.
`
`If any of the proposed product characteristics as stated in your April 24, 2015
`submission are altered, the name must be resubmitted for review. If you have further
`questions or need clarifications, please contact Darrell Lyons, OSE project manager, at
`301-796-4092.
`
`Reference ID: 3778132
`
`3
`
`

`

`REFERENCES
`
`1.
`
`2.
`
`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.
`
`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.
`
`Reference ID: 3778132
`
`4
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`JANINE A STEWART
`06/11/2015
`
`CHI-MING TU
`06/11/2015
`
`Reference ID: 3778132
`
`

`

`PROPRIETARY NAME REVIEW MEMORANDUM
`Division of Medication Error Prevention and Analysis (DMEPA)
`Office of Medication Error Prevention and Risk Management (OMEPRM)
`Office of Surveillance and Epidemiology (OSE)
`Center for Drug Evaluation and Research (CDER)
`
`*** This document contains proprietary information that cannot be released to the
`public***
`
`Date of This Review:
`Application Type and
`Number:
`Product Name and Strength:
`
`January 28, 2015
`NDA 207620
`
`Entresto (sacubitril/valsartan) Tablets,
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Submission Date:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Team Leader:
`
`Multi-Ingredient Product
`Rx
`Novartis Pharmaceuticals Corporation
`January 15, 2015
`2015-47393
`Janine Stewart, PharmD
`Chi-Ming (Alice) Tu, PharmD
`
`Reference ID: 3693757
`
`1
`
`(b) (4)
`
`

`

`1
`
`INTRODUCTION
`
`The proposed proprietary name, Entresto, was found acceptable in OSE Review #
`2014-25640, dated November 17, 2014 under IND 104628.1 We note that product
`characteristics are the same for NDA 207620 currently under review as they were under
`the IND. This memorandum is to communicate that DMEPA maintains the proposed
`proprietary name, Entresto, is acceptable from both a promotional and safety perspective
`under NDA 207620.
`
`1.1 COMMENTS TO THE APPLICANT
`
`We have completed our review of the proposed proprietary name, Entresto, and have
`concluded that this name is acceptable.
`
`If any of the proposed product characteristics as stated in your January 15, 2015
`submission are altered, the name must be resubmitted for review. If you have further
`questions or need clarifications, please contact Darrell Lyons, OSE project manager, at
`301-796-4092.
`
`
`1 Gao T. Proprietary Name Review for Entresto (IND 104628). Silver Spring (MD): Food and Drug
`Administration, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology,
`Division of Medication Error Prevention and Analysis (US); 20141117. 36 p. OSE RCM No.: 2014-25640.
`
`Reference ID: 3693757
`
`2
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`JANINE A STEWART
`01/28/2015
`
`CHI-MING TU
`01/28/2015
`
`Reference ID: 3693757
`
`

`

`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:
`Application Type and Number:
`Product Name and Strength:
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Submission Date:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Team Leader:
`
`November 17, 2014
`IND 104628
`Entresto (sacubitril/valsartan) Tablets,
`50 mg, 100 mg, 200 mg
`Multi-Ingredient Product
`Rx
`Novartis Pharmaceuticals Corporation
`June 19, 2014
`2014-25640
`Tingting Gao, PharmD
`Chi-Ming (Alice) Tu, PharmD
`
`Reference ID: 3659074
`
`

`

`1
`
`Contents
`INTRODUCTION....................................................................................................... 1
`1.1
`Product Information ............................................................................................. 1
`2 RESULTS.................................................................................................................... 2
`2.1 Misbranding Assessment...................................................................................... 2
`2.2
`Safety Assessment................................................................................................ 2
`3 CONCLUSIONS ......................................................................................................... 4
`3.1
`Comments to the Applicant.................................................................................. 4
`4 REFERENCES ............................................................................................................ 5
`APPENDICES .................................................................................................................... 6
`
`Reference ID: 3659074
`
`

`

`1
`
`INTRODUCTION
`
`This review evaluates the proposed proprietary name, Entresto, from a safety and
`misbranding perspective. The sources and methods used to evaluate the proposed name
`are outlined in the reference section and Appendix A respectively. The Applicant did not
`submit an external name study for this proposed proprietary name.
`
`1.1
`
`PRODUCT INFORMATION
`
`The following product information is provided in the June 19, 2014 proprietary name
`submission.
`
`Intended Pronunciation: Not provided
`
`Active Ingredient: sacubitril/valsartan [Established name not yet confirmed]
`
`Indication of Use:
`
`(m4)
`
`Route of Administration: Oral
`
`Dosage Form: Fihn-coated tablets
`
`Strength: 50 mg, 100 mg, 200 mg
`
`0 50 mg tablet contains 24 mg of sacubitril / 26 mg of valsartan
`
`o
`
`100 mg tablet contains 49 mg of sacubitlil / 51 mg of valsartan
`
`o 200 mg tablet contains 97 mg of sacubitril/ 103 mg of valsartan
`
`Dose and Frequency: The therapeutic dose of Entresto is 200 mg twice a day. It is
`expected that lower doses will be introduced for up-titration and/or down-titration
`purposes. No dose adjustment is required for special subpopulations of patients.
`
`How Supplied:
`
`0 Bottles of f3 60, and 180 tablets.
`
`0
`
`(m4)
`
`Storage: Store below 30°C
`
`Reference ID: 3659074
`
`

`

`***We note in our internal July 18, 2014 email communication with Office of New Drug
`Quality Assessment (ONDQA), the proposed strengths 50 mg, 100 mg, and 200 mg may
`not be acceptable to ONDQA. Thus, we evaluated the proposed proprietary name by
`reviewing for dose and strength overlaps for:
`50 mg, 100 mg, 200 mg
`
`24 mg, 49 mg, 97 mg
`
`26 mg, 51 mg, 103 mg
`
`24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg***
`
`
`2 RESULTS
`The following sections provide information obtained and considered in the overall
`evaluation of the proposed proprietary name.
`
`2.1 MISBRANDING ASSESSMENT
`The Office of Prescription Drug Promotion (OPDP) initially did not recommend the use
`of the proposed proprietary name Entresto because it overstates the efficacy and
`minimize the risks associated with the drug product on July 3, 2014. However, upon
`further discussion, OPDP withdrawn their objection and determined that the proposed
`name would not misbrand the proposed product on November 4, 2014.
`DMEPA and the Division of Cardiovascular and Renal Products (DCRP) concurred with
`the findings of OPDP’s assessment of the proposed name.
`
`2.2 SAFETY ASSESSMENT
`The following aspects were considered in the safety evaluation of the name.
`
`2.2.1 United States Adopted Names (USAN) Search
`There is no USAN stem present in the proprietary name1.
`
`2.2.2 Components of the Proposed Proprietary Name
`The Applicant did not provide a derivation or intended meaning for the proposed name,
`Entresto 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
`Ninety-one practitioners participated in DMEPA’s prescription studies. The responses
`did not overlap with any currently marketed products nor did the responses sound or look
`similar to any currently marketed products or any products in the pipeline.
`
`
`1USAN stem search conducted on November 4, 2014.
`
`Reference ID: 3659074
`
`2
`
`

`

`In the outpatient written study, 24 of 32 participants correctly interpreted the prescription.
`In the inpatient written study, 23 of 30 participants correctly interpreted the prescription.
`Common misinterpretations in the written studies were substitution of ‘—trest—’ for ‘-tn'st-’
`and ‘-tryt—’ and ‘—sto’ for ‘-sta’ or ‘-sti’. In the voice study, 14 of the 29 participants
`correctly interpreted the prescription. Connnon misinterpretations in the voice study
`include: ‘Ent—’ for ‘Ant-’ and ‘—trest—’ for ‘-trust—’.
`
`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, July 3, 2014 e-mail, the Division of Cardiovascular and Renal
`Products ODCRP) 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 search2 organized as highly similar, moderately similar
`or low similarity for further evaluation.
`
`Table 1. POCA Search Results
`
`Number of
`
`Names
`
`combined match percentage score 549%
`
`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:
`
`2.2.6 Safety Analysis ofNames with Potential Orthographic, Spelling, and Phonetic
`Similarities
`
`Our analysis of the 235 names contained in Table 1 determined 235 names will not pose a
`risk for confusion as described in Appendices C through H.
`
`2.2. 7 Communication ofDMEPA ’s Analysis at Midpoint ofReview
`
`DMEPA cormnunicated our findings to the Division of Cardiovascular and Renal
`Products ODCRP) via e—mail on November 10, 2014. At that time we also requested
`additional information or concerns that could inform our review. Per e-mail
`
`correspondence from the DCRP on November 17, 2014, they stated no additional
`concerns with the proposed proprietary name, Entresto.
`
`2 POCA search conducted on November 4. 2014.
`
`Reference ID: 3659074
`
`

`

`3 CONCLUSIONS
`The proposed proprietary name is acceptable.
`If you have further questions or need clarifications, please contact Cherye Milburn, OSE
`project manager, at 301-796-2084.
`
`COMMENTS TO THE APPLICANT
`3.1
`We have completed our review of the proposed proprietary name, Entresto, and have
`concluded that this name is acceptable.
`A request for proprietary name review for Entresto should be submitted once the NDA is
`submitted.
`
`Reference ID: 3659074
`
`4
`
`

`

`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#).
`
`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: 3659074
`
`5
`
`

`

`APPENDICES
`Appendix A
`FDA’s Proprietary Name Risk Assessment evaluates proposed proprietary names for
`misbranding and safety concerns.
`1. Misbranding Assessment: For prescription drug products, OPDP assesses the
`name for misbranding concerns. . For over-the-counter (OTC) drug products, the
`misbranding assessment of the proposed name is conducted by DNCE. OPDP or
`DNCE evaluates proposed proprietary names to determine if the name is false or
`misleading, such as by making misrepresentations with respect to safety or
`efficacy. For example, a fanciful proprietary name may misbrand a product by
`suggesting that it has some unique effectiveness or composition when it does not
`(21 CFR 201.10(c)(3)). OPDP or 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 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. 3
`
`
`3 National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
`
`Reference ID: 3659074
`
`6
`
`

`

`*Table 2- Prescreening Checklist for Proposed Proprietary Name
`
`Answer the questions in the checklist below. Affirmative
`answers to any of these questions indicate a potential area of
`concern that should be carefully evaluated as described in this
`'dance.
`
`Y/N
`
`Is the proposed name obviously similar in spelling and pronunciation to
`other names?
`
`Proprietary names should not be similar in spelling or pronunciation to
`proprietary names, established names, or ingredients of other products.
`
`IN
`
`Are there medical and/or coined abbreviations in the ro n rieta
`
`name?
`
`Proprietary names should not incorporate medical abbreviations (e.g., QD,
`BID, or others commonly used for prescription communication) or coined
`abbreviations that have no established meanin .
`
`S Are there inert or inactive ingredients referenced in the proprietary
`name?
`
`Proprietary names should not incorporate any reference to an inert or inactive
`ingredient in a way that might create an impression that the ingredient’s value
`is greater than its true functional role in the formulation (21 CFR
`201 . 10(c)(4)).
`
`
`
`IN
`
`Does the we I rieta
`
`name include combinations of active in_redients?
`
`Proprietary names of fixed combination drug products should not include or
`suggest the name of one or more, but not all, of its active ingredients (see 21
`CFR 201.6 I
`
`Y/N
`
`Is there a United States Adopted Name (USAN) stem in the proprietary
`name?
`
`Proprietary names should not incorporate a USAN stem in the position that
`USAN designates for the stem.
`
`YIN
`
`Is this proprietary name used for another product that does not share at
`least one common active in_redient?
`
`Drug products that do not contain at least one common active ingredient
`should not use the same root
`.ro u.riet
`name.
`
`Y/N
`
`Is this a to u rieta
`
`name of a discontinued .roduct?
`
`Proprietary names should not use the proprietary name of a discontinued
`product if that discontinued drug product does not contain the same active
`in u edients.
`
`Reference ID: 3659074
`
`

`

`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:
`• Highly similar pair: combined match percentage score ≥70%.
`• Moderately similar pair: combined match percentage score ≥50% to ≤ 69%.
`• Low similarity: combined match percentage score ≤49%.
`Using the criteria outlined in the check list (Table 3-5) that corresponds to each of the
`three categories (highly similar pair, moderately similar pair, and low similarity),
`DMEPA evaluates the name pairs to determine the acceptability or non-acceptability
`of a proposed proprietary name. The intent of these checklists is to increase the
`transparency and predictability of the safety determination of whether a proposed
`name is vulnerable to confusion from a look-alike or sound-alike perspective. Each
`bullet below corresponds to the name similarity category cross-references the
`respective table that addresses criteria that DMEPA uses to determine whether a name
`presents a safety concern from a look-alike or sound-alike perspective.
` For highly similar names, differences in product characteristics often cannot
`mitigate the risk of a medication error, including product differences such as
`strength and dose. Thus, proposed proprietary names that have a combined score
`of ≥ 70 percent are at risk for a look-alike sound-alike confusion which is an area
`of concern (See Table 3).
` Moderately similar names 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, and it can be an important factor that either increases or decreases the
`potential for confusion between similarly named drug pairs. The ability of other
`product characteristics to mitigate confusion (e.g., route, frequency, dosage form,
`etc.) may be limited when the strength or dose overlaps. We review such names
`further, to determine whether sufficient differences exist to prevent confusion.
`(See Table 4).
` Names with low similarity that have no overlap or similarity in strength and dose
`are generally acceptable (See Table 5) unless there are data to suggest that the
`name might be vulnerable to confusion (e.g., prescription simulation study
`suggests that the name is likely to be misinterpreted as a marketed product). In
`these instances, we would reassign a low similarity name to the moderate
`similarity category and review according to the moderately similar name pair
`checklist.
`
`Reference ID: 3659074
`
`8
`
`

`

`c. FDA Prescription Simulation Studies: DMEPA staff also conducts a prescription
`simulation studies using FDA health care professionals.
`Three separate studies are conducted within the Centers of the FDA for the proposed
`proprietary name to determine the degree of confusion of the proposed proprietary
`name with marketed U.S. drug names (proprietary and established) due to similarity
`in visual appearance with handwritten prescriptions or verbal pronunciation of the
`drug name. The studies employ healthcare professionals (pharmacists, physicians,
`and nurses), and attempts to simulate the prescription ordering process. The primary
`Safety Evaluator uses the results to identify orthographic or phonetic vulnerability of
`the proposed name to be misinterpreted by healthcare practitioners.
`In order to evaluate the potential for misinterpretation of the proposed proprietary
`name in handwriting and verbal communication of the name, inpatient medication
`orders and/or outpatient prescriptions are written, each consisting of a combination of
`marketed and unapproved drug products, including the proposed name. These orders
`are optically scanned and one prescription is delivered to a random sample of
`participating health professionals via e-mail. In addition, a verbal prescription is
`recorded on voice mail. The voice mail messages are then sent to a random sample of
`the participating health professionals for their interpretations and review. After
`receiving either the written or verbal prescription orders, the participants record their
`interpretations of the orders which are recorded electronically.
`d. Comments from Other Review Disciplines: DMEPA requests the Office of New
`Drugs (OND) and/or Office of Generic Drugs (OGD), ONDQA or OBP for their
`comments or concerns with the proposed proprietary name, ask for any clinical issues
`that may impact the DMEPA review during the initial phase of the name review.
`Additionally, when applicable, at the same time DMEPA requests concurrence/non-
`concurrence with OPDP’s decision on the name. The primary Safety Evaluator
`addresses any comments or concerns in the safety evaluator’s assessment.
`The OND/OGD Regulatory Division is contacted a second time following our
`analysis of the proposed proprietary name. At this point, DMEPA conveys their
`decision to accept or reject the name. The OND or OGD Regulatory Division is
`requested to provide any further information that might inform DMEPA’s final
`decision on the proposed name.
`Additionally, other review disciplines opinions such as ONDQA or OBP may be
`considered depending on the proposed proprietary name.
`When provided, DMEPA considers external proprietary name studies conducted by or for
`the Applicant/Sponsor and incorporates the findings of these studies into the overall risk
`assessment.
`The DMEPA primary reviewer assigned to evaluate the proposed proprietary name is
`responsible for considering the collective findings, and provides an overall risk
`assessment of the proposed proprietary name.
`
`Reference ID: 3659074
`
`9
`
`

`

`pronounced differently?
`
`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
`
`Table 3. Highly Similar Name Pair Checklist (i.e., combined Orthographic and
`Phonetic score is Z 70% .
`
`Answer the questions in the checklist below. Afiirmative answers to some of these
`questions suggest that the pattern of orthographic or phonetic differences in the
`names may render the names less likely to confusion, provided that the pair do not
`share a common strength or dose.
`
`Orthographic Checklist
`
`Phonetic Checklist
`
`Do the names begin with
`different first letters?
`
`Note that even when names begin
`with diflerentfirst letters, certain
`letteis may be confilsed with each
`other when scripted.
`
`Are the lengths of the names
`dissimilar" when scripted?
`
`*FDA considers the length ofnames
`dificrent ifthe names difier by two or
`more letters.
`
`Considering variations in
`scripting of some letters (such
`as : andj), 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: 3659074
`
`10
`
`

`

`Table 4: Moderately Similar Name Pair Checklist (i.e., combined score is ≥50% to
`≤69%).
`Step 1 Review the DOSAGE AND ADMINISTRATION and HOW
`SUPPLIED/STORAGE AND HANDLING sections of the prescribing
`information (or for OTC drugs refer to the Drug Facts label) to determine if
`strengths and doses of the name pair overlap or are very similar. Different
`strengths and doses for products whose names are moderately similar may
`decrease the risk of confusion between the moderately similar name pairs. Name
`pairs that have overlapping or similar strengths or doses have a higher potential
`for confusion and should be evaluated further (see Step 2). Because the strength
`or dose could be used to express an order or prescription for a particular drug
`product, overlap in one or both of these components would be reason for further
`evaluation.
`
`For single strength products, also consider circumstances where the strength may
`not be expressed.
`For any i.e. drug products comprised of more than one active ingredient,
`consider whether the strength or dose may be expressed using only one of the
`components.
`
`To determine whether the strengths or doses are similar to your proposed
`product, consider the following list of factors that may increase confusion:
`
`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 some of
`these questions suggest that the pattern of orthographic or phonetic differences in
`the names may reduce the likelihood of confusion for moderately similar names
`with overlapping or similar strengths or doses.
`
`Reference ID: 3659074
`
`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: 3659074
`
`12
`
`

`

`Table 5: Low Similari Name Pair Checklist
`
`i.e., combined score is 549% .
`
`In most circumstances, these names are Viewed as