CENTER FOR DRUG EVALUATION AND
`
`
`
` RESEARCH
`
`
`
`
` APPLICATION NUMBER:
`
`
` 208276Orig1s000
`
`
`
`
`
` PROPRIETARY NAME REVIEW(S)
`
`
`
`
`
`
`

`

`PROPRIETARY NAME 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:
`April 26, 2018
`Application Type and Number: NDA 208276
`Product Name and Strength:
`Implantable System for Remodulin
`[for use with Remodulin (Treprostinil) Injection
` 200 mg/20 mL]
`Device
`Rx
`United Therapeutics Corporation
`2018-20666737
`Maximilian Straka, PharmD, FISMP
`Chi-Ming (Alice) Tu, PharmD, BCPS, FISMP
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Panorama #:
`DMEPA Safety Evaluator:
`DMEPA Team Leader:
`
`
`
`Reference ID: 4254661Reference ID: 4409052
`
`

`

`INTRODUCTION
`1
`This memorandum is to reassess the proposed proprietary name, Implantable System for
`Remodulin, which was found conditionally acceptable under NDA 208276 on April 7, 2017.a
`
`We note that all product characteristics remain the same.
`
`2 METHODS AND DISCUSSION
`
`2.1 SAFETY ASSESSMENT
`The appropriateness of the root name, Remodulin, and the modifiers, “Implantable System for”
`were evaluated and found acceptable in our previous review and we maintain our previous
`decision. b For re-assessment of the proposed proprietary name, DMEPA searched the USAN
`stem list to determine if the name contains any USAN stems as of the last USAN updates. The
`February 2, 2018, search of USAN stems did not find any USAN stems in the proposed
`proprietary name.
`
`2.2 COMMUNICATION OF DMEPA’S ANALYSIS AT MIDPOINT OF REVIEW
`DMEPA communicated our findings to the Division of Cardiovascular and Renal Products
`(DCRP) via e-mail on April 19, 2018. At that time we also requested additional information or
`concerns that could inform our review. The Division of Cardiovascular and Renal Products did
`not forward any additional concerns with the proposed proprietary name, Implantable System for
`Remodulin.
`
`3 CONCLUSIONS
`Our re-assessment did not identify any safety concerns. Therefore, we maintain that the proposed
`proprietary name is acceptable.
`
`If you have any questions or need clarifications, please contact Darrell Lyons, OSE project
`manager, at 301-796-4092.
`
`3.1 COMMENTS TO THE APPLICANT
`We have completed our review of the proposed proprietary name, Implantable System for
`Remodulin, and have concluded that this name is acceptable.
`If any of the proposed product characteristics as stated in your submission, received on January
`30, 2018, are altered prior to approval of the marketing application, the name must be
`resubmitted for review.
`
`a Thomas, S. Proprietary Name Review for Implantable System for Remodulin (NDA 208276). Silver Spring (MD):
`FDA, CDER, OSE, DMEPA (US);2017 Apr 7. Panorama No. 2016- 12573862.
`
`b Thomas, S. Proprietary Name Review for Implantable System for Remodulin (NDA 208276). Silver Spring (MD):
`FDA, CDER, OSE, DMEPA (US);2017 Apr 7. Panorama No. 2016- 12573862.
`
`
`
`Reference ID: 4254661Reference ID: 4409052
`
`

`

`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.
`
`
`
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`

`

`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`MAXIMILIAN STRAKA
`04/26/2018
`
`CHI-MING TU
`04/26/2018
`
`
`
`Reference ID: 4254661Reference ID: 4409052
`
`

`

`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:
`April 7, 2017
`Application Type and Number: NDA 208276
`Product Name and Strength:
`Implantable System for Remodulin
`[for use with Remodulin (Treprostinil) Injection
` 200 mg/ 20 mL]
`Device
`Rx
`United Therapeutics Corporation
`2016-12573862
`Sarah Thomas, PharmD
`Chi-Ming (Alice) Tu, PharmD, BCPS
`Danielle Harris, PharmD, BCPS
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Team Leader:
`Associate Director (Acting):
`
`Reference ID: 4081391
`Reference ID: 4409052
`
`

`

`1
`
`Contents
`INTRODUCTION....................................................................................................................1
`
`1.1 Regulatory History............................................................................................................1
`
`1.2
`Product Information ..........................................................................................................1
`
`2 RESULTS.................................................................................................................................2
`
`2.1 Misbranding Assessment ..................................................................................................2
`
`2.2
`Safety Assessment.............................................................................................................2
`
`3 CONCLUSIONS ......................................................................................................................4
`
`3.1 Comments to the Applicant...............................................................................................5
`
`REFERENCES ................................................................................................................................6
`
`APPENDICES .................................................................................................................................7
`
`
`
`
`Reference ID: 4081391
`Reference ID: 4409052
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`

`

`INTRODUCTION
`1
`This review evaluates the proposed proprietary name, Implantable System for Remodulin, 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.
`
`REGULATORY HISTORY
`1.1
`The Applicant previously submitted the proposed proprietary name,
`
`***, on June 16, 2016. Since the implantable pump will be packaged separately from
`Remodulin, the proposed proprietary name
`***” would be
`misleading because end users might be misled to believe the device package already contains the
`drug Remodulin inside. At a teleconference on July 15, 2016 , we recommended that United
`Therapeutics Corporation consider the name, “Implantable System for Remodulin”, to address
`our concerns.
`***”, and
`Thereafter, the Applicant withdrew the name,
`submitted the name, “Implantable System for Remodulin,” for review on August 5, 2016.
`However, NDA 208276 received a complete response on October 8, 2016 secondary to the
`device remaining under a CDRH Not Approvable letter.
`The Applicant resubmitted NDA 208276 for review under a Class 1 resubmission on December
`15, 2016. Subsequently, the proposed proprietary name, “Implantable System for Remodulin,”
`was resubmitted for review on January 13, 2017.
`
`1.2 PRODUCT INFORMATION
`The following Remodulin drug product information is provided in the December 15, 2016
`submission, as well as obtained from the Remodulin Prescribing Information.
`Intended Pronunciation: not provided in submissions
`•
`• Active Ingredient: Treprostinil
`Indication of Use: The Implantable System for Remodulin consists of the drug product
`•
`Remodulin (treprostinil) Injection and a fully implanted, programmable infusion system
`for chronic intravenous delivery of the drug product in patients with pulmonary arterial
`hypertension to diminish symptoms associated with exercise.
`• Route of Administration: Intravenous
`• Dosage Form: Injection
`
`•
` Strength: Remodulin (treprostinil) Injection is available by prescription in four strengths
`(20 mg/20 mL, 50 mg/20 mL, 100 mg/20 mL, and 200 mg/20 mL);
`
`
`
`
`
`• Dose and Frequency: Per Remodulin Prescribing Information Highlights Section, PAH
`in patients with NYHA Class II-IV symptoms:
`
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`1
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
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`

`

`•
`
`Initial dose for patients new to prostacyclin infusion therapy: 1.25 ng/kg/min;
`increase based on clinical response (increments of 1.25 ng/kg/min per week for the
`first 4 weeks of treatment, later 2.5 ng/kg/min per week). Avoid abrupt cessation.
`• Mild to moderate hepatic insufficiency: Decrease initial dose to 0.625 ng/kg/min.
`Severe hepatic insufficiency: No studies performed.
`• How Supplied:
`o Remodulin is currently provided to patients through specialty pharmacies.
`Remodulin will continue to be marketed by itself as the drug only (20 mL multi-
`dose vials as sterile solutions in water for injection, individually packaged in
`cartons), and the option of using the Implantable System for Remodulin will be
`noted on the vial container label and carton labeling. Remodulin will be
`distributed for use either in the Implantable System for Remodulin or with an
`external pump, either intravenous or subcutaneous, as currently approved. United
`Therapeutics Corporation is intending to provide both the current Remodulin
`package insert as well as the Implantable System for Remodulin package insert
`with each carton of Remodulin.
`o The device components of the Implantable System for Remodulin will be
`packaged and sold separately from the drug. The Implantable System for
`Remodulin will initially be filled in a hospital setting at the time of pump implant,
`and refills of the implanted pump will be administered by a qualified healthcare
`provider.
`• Storage: Unopened vials of Remodulin are stable until the date indicated when stored at
`25°C (77°F), with excursions permitted to 2-30°C (36-86°F).
`
`2 RESULTS
`The following sections provide information obtained and considered in the overall evaluation of
`the proposed proprietary name.
`
`2.1 MISBRANDING ASSESSMENT
`The Office of Prescription Drug Promotion (OPDP) determined that the proposed name would
`not misbrand the proposed product. DMEPA and the Division of 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 namea.
`
`a USAN stem search conducted on February 28, 2017.
`
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`2
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`

`

`2.2.2 Components of the Proposed Proprietary Name
`The Applicant did not provide a derivation or intended meaning for the proposed name,
`Implantable System for Remodulin, in their submission. This proprietary name is comprised of
`the modifier “Implantable System for”, followed by the root name “Remodulin”. We evaluated
`the appropriateness of the modifier in section 2.2.5, and the use of the root name, Remodulin, in
`section 2.2.6.
`
`2.2.3 FDA Name Simulation Studies
`Eighty-seven practitioners participated in DMEPA’s prescription studies. Thirty-seven
`participants interpreted Implantable System for Remodulin correctly in the inpatient and
`outpatient handwritten prescription studies and verbal prescription studies. Of note, a common
`misinterpretation observed in the outpatient written prescription study involved participants
`misinterpreting the letter “R” in the prefix “Rem” as the letter “B” (e.g., “Bem”) (n=20 in the
`outpatient study). 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. 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 8, 2017 e-mail, the Division of Cardiovascular and Renal
`Products (DCRP) did not forward any comments or concerns relating to the proposed proprietary
`name at the initial phase of the review.
`
`2.2.5 Analysis of the Modifier “Implantable System for”
`
`There is currently no implantable infusion system marketed for Remodulin. The modifier
`“Implantable System for” is a novel modifier. The proposed device is an implantable system,
`and the intended use involves surgical implantation of the device to provide for continuous
`delivery of Remodulin. Therefore, the use of the modifier “Implantable System for” within the
`proposed proprietary name “Implantable System for Remodulin” is appropriate.
`
`2.2.6 Medication Error Data Selection of Cases
`
`We searched the FDA Adverse Event Reporting System (FAERS) database using the strategy
`listed in Table 2 (see Appendix A1 for a description of FAERS database) for name confusion
`errors involving Remodulin that would be relevant for this review.
`
`Table 2. FAERS Search Strategy
`Search Date
`January 24, 2017
`Remodulin [product name]
`Drug Name
`Remodulin [product verbatim] (Selected all
`associated names)
`Medication Error Event PT
`and
`
`Event (MedDRA
`Terms)
`
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`3
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`

`

`DMEPA Official PNR Name Confusion Search
`Terms Event List:
`Preferred Terms:
`CIRCUMSTANCE OR INFORMATION CAPABLE OF
`LEADING TO MEDICATION ERROR
`DRUG ADMINISTRATION ERROR)
`DRUG DISPENSING ERROR
`DRUG PRESCRIBING ERROR
`INTERCEPTED DRUG DISPENSING ERROR
`INTERCEPTED DRUG PRESCRIBING ERROR
`INTERCEPTED MEDICATION ERROR
`MEDICATION ERROR
`PRODUCT NAME CONFUSION
`TRANSCRIPTION MEDICATION ERROR
`
`Lower Level Terms:
`INTERCEPTED PRODUCT SELECTION ERROR
`INTERCEPTED WRONG DRUG PRODUCT SELECTED
`INTERCEPTED WRONG DRUG SELECTED
`PRODUCT SELECTION ERROR
`WRONG DEVICE DISPENSED
`WRONG DRUG ADMINISTERED
`WRONG DRUG DISPENSED
`WRONG DRUG PRESCRIBED
`WRONG DRUG PRODUCT SELECTED
`WRONG DRUG SELECTED
`WRONG PRODUCT SELECTED
`Date Limits
`From July 5, 2001 to search date
`Each report was reviewed for relevancy and duplication. The NCC MERP Taxonomy of
`Medication Errors was used to code the case outcome and error root causes when provided by
`the reporter.
`After individual review, our search identified 48 cases, of which none are relevant for this
`proposed proprietary name review as they did not involve proprietary name confusion. Thus, we
`find the use of the root name Remodulin acceptable.
`
`
`2.2.7 Communication of DMEPA’s Analysis at Midpoint of Review
`DMEPA communicated our findings to the Division of Cardiovascular and Renal Product
`(DCRP) via e-mail on April 3, 2017. At that time we also requested additional information or
`concerns that could inform our review. Per e-mail correspondence from the DCRP on April 6,
`2017, they stated no additional concerns with the proposed proprietary name, Implantable
`System for Remodulin.
`
`3 CONCLUSIONS
`The proposed proprietary name is acceptable.
`
`Reference ID: 4081391
`Reference ID: 4409052
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`4
`
`

`

`If you have any questions or need clarifications, please contact Darrell Lyons, OSE project
`manager, at 301-796-4092.
`
`COMMENTS TO THE APPLICANT
`3.1
`We have completed our review of the proposed proprietary name, Implantable System for
`Remodulin, and have concluded that this name is acceptable.
`If any of the proposed product characteristics as stated in your December 15, 2016 submission
`are altered prior to approval of the marketing application, the name must be resubmitted for
`review.
`
`Reference ID: 4081391
`Reference ID: 4409052
`
`5
`
`

`

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

`APPENDICES
`Appendix A
`FDA’s Proprietary Name Risk Assessment evaluates proposed proprietary names for
`misbranding and safety concerns.
`1. Misbranding Assessment: For prescription drug products, OPDP assesses the name for
`misbranding concerns. . For over-the-counter (OTC) drug products, the misbranding
`assessment of the proposed name is conducted by DNDP. OPDP or DNDP evaluates
`proposed proprietary names to determine if the name is false or misleading, such as by
`making misrepresentations with respect to safety or efficacy. For example, a fanciful
`proprietary name may misbrand a product by suggesting that it has some unique
`effectiveness or composition when it does not (21 CFR 201.10(c)(3)). OPDP or DNDP
`provides their opinion to DMEPA for consideration in the overall acceptability of the
`proposed proprietary name.
`2. Safety Assessment: The safety assessment is conducted by DMEPA, and includes the
`following:
`a. Preliminary Assessment: We consider inclusion of USAN stems or other characteristics
`that when incorporated into a proprietary name may cause or contribute to medication
`errors (i.e., dosing interval, dosage form/route of administration, medical or product name
`abbreviations, names that include or suggest the composition of the drug product, etc.)
`See prescreening checklist below in Table 2*. DMEPA defines a medication error as any
`preventable event that may cause or lead to inappropriate medication use or patient harm
`while the medication is in the control of the health care professional, patient, or
`consumer. b
`
`b National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
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`*Table 2- Prescreening Checklist for Proposed Proprietary Name
`
`Y/N
`
`Answer the questions in the checklist below. Affirmative answers
`to any of these questions indicate a potential area of concern that
`should be carefully evaluated as described in this guidance.
`Is the proposed name obviously similar in spelling and pronunciation to other
`names?
`Proprietary names should not be similar in spelling or pronunciation to proprietary
`names, established names, or ingredients of other products.
`Y/N Are there medical and/or coined abbreviations in the proprietary 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 meaning.
`Y/N Are there inert or inactive ingredients referenced in the proprietary name?
`Proprietary names should not incorporate any reference to an inert or inactive
`ingredient in a way that might create an impression that the ingredient’s value is
`greater than its true functional role in the formulation (21 CFR 201.10(c)(4)).
`Y/N Does the proprietary name include combinations of active ingredients?
`Proprietary names of fixed combination drug products should not include or
`suggest the name of one or more, but not all, of its active ingredients (see 21 CFR
`201.6(b)).
`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.
`Is this proprietary name used for another product that does not share at least
`one common active ingredient?
`Drug products that do not contain at least one common active ingredient should not
`use the same (root) proprietary name.
`Is this a proprietary name of a discontinued product?
`Proprietary names should not use the proprietary name of a discontinued product if
`that discontinued drug product does not contain the same active ingredients.
`
`Y/N
`
`Y/N
`
`Y/N
`
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`

`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.
`
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`

`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: 4081391
`Reference ID: 4409052
`
`10
`
`

`

`Table 3. Highly Similar Name Pair Checklist (i.e., combined Orthographic and Phonetic
`score is ≥ 70%).
`Answer the questions in the checklist below. Affirmative answers to some of these
`questions suggest that the pattern of orthographic or phonetic differences in the names
`may render the names less likely to confusion, provided that the pair does not share a
`common strength or dose.
`
`Phonetic Checklist
`Y/N Do the names have different
`number of syllables?
`
`Y/N Do the names have different
`syllabic stresses?
`
`Y/N Do the syllables have different
`phonologic processes, such
`vowel reduction, assimilation,
`or deletion?
`
`Y/N Across a range of dialects, are
`the names consistently
`pronounced differently?
`
`Orthographic Checklist
`Y/N Do the names begin with different
`first letters?
`Note that even when names begin with
`different first letters, certain letters may be
`confused with each other when scripted.
`Y/N Are the lengths of the names
`dissimilar* when scripted?
`
`*FDA considers the length of names
`different if the names differ by two or more
`
`letters.
`Y/N Considering variations in scripting of
`some letters (such as z and f), is there
`a different number or placement of
`upstroke/downstroke letters present
`in the names?
`
`Y/N
`
`Is there different number or
`placement of cross-stroke or dotted
`letters present in the names?
`Y/N Do the infixes of the name appear
`dissimilar when scripted?
`
`Y/N Do the suffixes of the names appear
`dissimilar when scripted?
`
`Reference ID: 4081391
`Reference ID: 4409052
`
`11
`
`

`

`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:
`
`• Alternative expressions of dose: 5 mL may be listed in the prescribing
`information, but the dose may be expressed in metric weight (e.g., 500
`mg) or in non-metric units (e.g., 1 tsp, 1 tablet/capsule). Similarly, a
`strength or dose of 1000 mg may be expressed, in practice, as 1 g, or vice
`versa.
`
`• Trailing or deleting zeros: 10 mg is similar in appearance to 100 mg
`which may potentiate confusion between a name pair with moderate
`similarity.
`
`• Similar sounding doses: 15 mg is similar in sound to 50 mg
`
`Step 2 Answer the questions in the checklist below. Affirmative answers to some of
`these questions suggest that the pattern of orthographic or phonetic differences in
`the names may reduce the likelihood of confusion for moderately similar names
`with overlapping or similar strengths or doses.
`
`Reference ID: 4081391
`Reference ID: 4409052
`
`12
`
`

`

`Phonetic Checklist (Y/N to each
`question)
`• Do the names have different
`number of sy