CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`212535Orig1s000
`
`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:
`September 5, 2019
`Application Type and Number: NDA 212535
`Product Name and Strength:
`Nouress (cysteine hydrochloride, USP) Injection,
`500 mg/10 mL (50 mg/mL)
`50 mg/mL
`Single Ingredient Product
`Prescription (Rx)
`Avadel Legacy Pharmaceuticals, LLC
`2019-32766541
`Lissa C. Owens, PharmD
`Idalia E. Rychlik, PharmD
`
`Total Product Strength:
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Panorama #:
`DMEPA Safety Evaluator:
`DMEPA Team Leader:
`
`
`
`Reference ID: 4487065Reference ID: 4534716
`
`

`

`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 CONCLUSION ........................................................................................................................3
`3.1
`Comments to Avadel Legacy Pharmaceuticals, LLC......................................................3
`4 REFERENCES.........................................................................................................................4
`APPENDICES .................................................................................................................................5
`
`
`
`
`
`Reference ID: 4487065Reference ID: 4534716
`
`

`

`INTRODUCTION
`1
`This review evaluates the proposed proprietary name, Nouress, from a safety and misbranding
`perspective. The sources and methods used to evaluate the proposed proprietary name are
`outlined in the reference section and Appendix A respectively. Avadel Legacy Pharmaceuticals,
`LLC submitted an external name study, conducted by
`, for this proposed proprietary
`name.
`
`1.1 REGULATORY HISTORY
`Avadel previously submitted the proposed proprietary name, previous proposed name
`*** on March 18, 2019. However, we found the previous proposed name
`unacceptable due to similarity in spelling with the proprietary name,
` under NDA
`212535 on June 12, 2019a.
`Thus, Avadel submitted the name, Nouress, for review on June 27, 2019.
`
`***
`
`PRODUCT INFORMATION
`1.2
`The following product information is provided in the proprietary name submission received on
`June 27, 2019.
`Intended Pronunciation: nur-es
`
` Active Ingredient: cysteine hydrochloride, USP
`Indication of Use: For use as an additive to amino acids solutions to meet nutritional
`
`requirements of neonates requiring total parenteral nutrition (TPN)
` Route of Administration: Intravenous Infusion
` Dosage Form: Injection
` Strength: 500 mg/10 mL (50 mg/mL)
` Dose and Frequency: For addition to amino acids solutions intended for use in neonates,
`it is recommended that NOURESS be added to the amino acids solution to provide
`cysteine at % of the total amino acids being supplied. Hence, a neonate receiving
`
`amino acids solutions at
`g/kg/day should be provided mg/kg/day of cysteine or
`mL/kg/day of NOURESS
`. A neonate receiving 3 g/kg/day of amino acids should be
`provided mL/kg/day of NOURESS
`.
`The amino acids admixture should then be aseptically diluted with appropriate caloric
`substrates calculated to supply the patient with adequate energy. The admixture should be
`refrigerated until ready for use and used within 24 hours of the time of mixing.
`vials)
` How Supplied: 10 mL single dose vial (single and package of
` Storage: Store at controlled room temperature 15°-30°C (59°-86°F) Do not freeze.
`
` (NDA 212535). Silver Spring (MD): FDA, CDER, OSE,
`a McMillan, T. Proprietary Name Review for
`DMEPA (US); 2019 JUN 12. Panorama No. 2019- 30148818
`
`
`
`Reference ID: 4487065Reference ID: 4534716
`
`1
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`(b)
`(4)
`
`(b)
`(4)
`
`(b) (4)
`
`(b)
`(4)
`
`(b)
`(4)
`
`(b) (4)
`
`(b) (4)
`
`(b) (4)
`
`

`

`2 RESULTS
`The following sections provide information obtained and considered in the overall evaluation of
`the proposed proprietary name, Nouress.
`
`2.1 MISBRANDING ASSESSMENT
`The Office of Prescription Drug Promotion (OPDP) determined that Nouress would not
`misbrand the proposed product. The Division of Medication Error Prevention and Analysis
`(DMEPA) and the Division of Gastroenterology and Inborn Errors Products (DGIEP) concurred
`with the findings of OPDP’s assessment for Nouress.
`
`2.2 SAFETY ASSESSMENT
`The following aspects were considered in the safety evaluation of the proposed proprietary name,
`Nouress.
`
`2.2.1 United States Adopted Names (USAN) Search
`
`There is no USAN stem present in the proposed proprietary name1F
`
`b
`
`2.2.2 Components of the Proposed Proprietary Name
`Avadel did not provide a derivation or intended meaning for the proposed proprietary name,
`Nouress, 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 Comments from Other Review Disciplines at Initial Review
`In response to the OSE, July 12, 2019 e-mail, the Division of Gastroenterology and Inborn Errors
`Products (DGIEP) did not forward any comments or concerns relating to Nouress at the initial
`phase of the review.
`
`2.2.4 FDA Name Simulation Studies
`Eighty-seven practitioners participated in DMEPA’s prescription studies for Nouress. 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.
`
`2.2.5 Phonetic and Orthographic Computer Analysis (POCA) Search Results
`Our POCA search4F
`c identified 84 names with a combined phonetic and orthographic score of
`≥55% or an individual phonetic or orthographic score ≥70%. These names are included in Table
`1 below.
`
`b USAN stem search conducted on August 12, 2019.
`c POCA search conducted on August 12, 2019 in version 4.3.
`
`
`
`Reference ID: 4487065Reference ID: 4534716
`
`2
`
`

`

`2.2.6 Names Retrieved for Review Organized by Name Pair Similarity
` external study.
`Table 1 lists the number of names retrieved from our POCA search and
`These name pairs are organized as highly similar, moderately similar or low similarity for further
`evaluation.
`
`Table 1. Names Retrieved for Review Organized by Name Pair Similarity
`Similarity Category
`Number of Names
`Highly similar name pair:
`2
`combined match percentage score ≥70%
`Moderately similar name pair:
`combined match percentage score ≥55% to ≤ 69%
`Low similarity name pair:
`combined match percentage score ≤54%
`
`83
`
`11
`
`2.2.7 Safety Analysis of Names with Potential Orthographic, Spelling, and Phonetic
`Similarities
`Our analysis of the 96 names contained in Table 1 determined none of the names will pose a risk
`for confusion with Nouress as described in Appendices C through H.
`
`2.2.8 Communication of DMEPA’s Analysis at Midpoint of Review
`DMEPA communicated our findings to the Division of Gastroenterology and Inborn Errors
`Products (DGIEP) via e-mail on September 5, 2019. At that time, we also requested additional
`information or concerns that could inform our review. Per e-mail correspondence from the
`Division of Gastroenterology and Inborn Errors Products (DGIEP) on September 5, 2019, they
`stated no additional concerns with the proposed proprietary name, Nouress.
`
`3 CONCLUSION
`The proposed proprietary name, Nouress, is acceptable.
`If you have further questions or need clarifications, please contact Alvis Dunson, OSE project
`manager, at 301-796-6400.
`
`COMMENTS TO AVADEL LEGACY PHARMACEUTICALS, LLC
`3.1
`We have completed our review of the proposed proprietary name, Nouress, and have concluded
`that this name is acceptable.
`If any of the proposed product characteristics as stated in your submission, received on June 27,
`2019, are altered prior to approval of the marketing application, the name must be resubmitted
`for review.
`
`
`
`Reference ID: 4487065Reference ID: 4534716
`
`3
`
`(b) (4)
`
`

`

`4
`
`REFERENCES
`
`1. USAN Stems (https://www.ama-assn.org/about/united-states-adopted-names-approved-stems)
`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: 4487065Reference ID: 4534716
`
`4
`
`

`

`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. F
`d
`
`d National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
`
`
`
`Reference ID: 4487065Reference ID: 4534716
`
`5
`
`

`

`*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 guidance.
`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.
`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)).
`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.
`Y/N 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.
`Y/N 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.
`
`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 55% 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 ≥55% to ≤ 69%.
`
`
`
`Reference ID: 4487065Reference ID: 4534716
`
`6
`
`

`

`• Low similarity: combined match percentage score ≤54%.
`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 are further evaluated to identify the presence of attributes that
`are known to cause name confusion.
` Name attributes: We note that the beginning of the drug name plays a
`significant role in contributing to confusion. Additionally, drug name pairs
`that start with the same first letter and contain a shared letter string of at
`least 3 letters in both names are major contributing factor in the confusion
`of drug names F
`e. We evaluate all moderately similar names retrieved from
`POCA to identify the above attributes. These names are further evaluated
`to identify overlapping or similar strengths or doses.
` Product attributes: Moderately similar names of products that have
`overlapping or similar strengths or doses represent an area for concern for
`FDA. The dose and strength information is often located in close
`proximity to the drug name itself on prescriptions and medication orders,
`and the information 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) may be limited when the strength or dose
`overlaps. DMEPA reviews 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
`
`e Shah, M, Merchant, L, Characteristics That May Help in the Identification of Potentially Confusing Proprietary
`Drug Names. Therapeutic Innovation & Regulatory Science, September 2016
`
`
`
`Reference ID: 4487065Reference ID: 4534716
`
`7
`
`

`

`a low similarity name to the moderate similarity category and review according to the
`moderately similar name pair checklist.
`
`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.
`
`
`
`Reference ID: 4487065Reference ID: 4534716
`
`8
`
`

`

`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 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.
`
`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?
`
`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?
`
`
`
`Reference ID: 4487065Reference ID: 4534716
`
`9
`
`

`

`Table 4: Moderately Similar Name Pair Checklist (i.e., combined score is ≥55% 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: 4487065Reference ID: 4534716
`
`10
`
`

`

`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?
`
`Orthographic Checklist (Y/N to each
`question)
` 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?
` 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 ≤54%).
`Names with low similarity 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.
`
`
`
`Reference ID: 4487065Reference ID: 4534716
`
`11
`
`

`

`Appendix B: Prescription Simulation Samples and Results
`Figure 1. Nouress Study (Conducted on July 12, 2019)
`
`Handwritten Medication Order/Prescription
`
`Medication Order:
`
`Outpatient Prescription:
`
`Verbal
`Prescription
`Nouress
`Bring to Clinic
`#5 vials
`
`
`
`Reference ID: 4487065Reference ID: 4534716
`
`12
`
`(b) (4)
`
`

`

`
`
`Reference ID: 4487065Reference ID: 4534716
`
`13
`
`

`

`Appendix C: Highly Similar Names (e.g., combined POCA score is ≥70%)
`No.
`Proposed name: Nouress
`POCA
`Orthographic and/or phonetic
`Established name: cysteine
`Score (%)
`differences in the names sufficient to
`prevent confusion
`hydrochloride, USP
`Dosage form: Injection
`Strength(s):
`500 mg/10 mL (50 mg/mL)
`Usual Dose: % of the total
`amino acids being supplied
`Nouress***
`Nourish
`
`Other prevention of failure mode
`expected to minimize the risk of
`confusion between these two names.
`
`100
`78
`
`Name is the subject of this review
`Product is a medical food.
`
`1.
`2.
`
`Appendix D: Moderately Similar Names (e.g., combined POCA score is ≥55% to ≤69%) with
`no overlap or numerical similarity in Strength and/or Dose
`No.
`Name
`POCA
`Score (%)
`61
`61
`61
`60
`58
`57
`57
`56
`55
`55
`
`Fluress
`Nutr-E-Sol
`Nourianz***
`Ocupress
`Nora-Be
`Enpresse-21
`Enpresse-28
`Nucort
`Solurex
`Journee
`
`3.
`4.
`5.
`6.
`7.
`8.
`9.
`10.
`11.
`12.
`
`Appendix E: Moderately Similar Names (e.g., combined POCA score is ≥55% to ≤69%) with
`overlap or numerical similarity in Strength and/or Dose
`No.
`Proposed name: Nouress
`POCA
`Established name: cysteine
`Score (%)
`hydrochloride, USP
`Dosage form: Injection
`Strength(s):
`500 mg/10 mL (50 mg/mL)
`Usual Dose: % of the total
`amino acids being supplied
`Norisc
`
`Prevention of Failure Mode
`
`In the conditions outlined below, the
`following combination of factors, are
`expected to minimize the risk of
`confusion between these two names
`
`68
`
`This name pair has sufficient
`orthographic differences. Phonetically,
`the ending sounds of the second
`syllable (ress vs. risc) sound different.
`
`13.
`
`Norisc is available in a cream and a
`wash/solution whereas Nouress is
`
`
`
`Reference ID: 4487065Reference ID: 4534716
`
`14
`
`(b)
`(4)
`
`(b)
`(4)
`
`

`

`No.
`
`POCA
`Score (%)
`
`Proposed name: Nouress
`Established name: cysteine
`hydrochloride, USP
`Dosage form: Injection
`Strength(s):
`500 mg/10 mL (50 mg/mL)
`Usual Dose: % of the total
`amino acids being supplied
`
`14.
`
`Neotuss
`
`67
`
`
`
`Reference ID: 4487065Reference ID: 4534716
`
`15
`
`Prevention of Failure Mode
`
`In the conditions outlined below, the
`following combination of factors, are
`expected to minimize the risk of
`confusion between these two names
`
`available in a single injection dosage
`form. The dosage form of Norisc
`would be specified on a medication
`order/prescription.
`
`The dose of Norisc is to use as directed
`or apply to affected area which does
`not overlap with the dose of Nouress
`which is dependent on the total amount
`of amino acids being supplied and
`weight-based ( % of total amino
`acids).
`
`Nouress will be used as an additive in
`amino acid/TPN solutions, which in
`clinical practice is considered a high
`alert medication requiring special
`safeguards in various points of the
`medication use process to reduce the
`risk of error. Furthermore, additives
`for TPN solutions are typically ordered
`by the established name (e.g.,
`cysteine) using a TPN prescription/
`order program and it is not anticipated
`that Nouress will be written on a
`medication order alone. Additionally,
`there are compatibility considerations
`with TPN solutions.
`Neotuss has an upstroke letter ‘t’ in the
`infix which provides some
`orthographic differences. Phonetically,
`Neotuss has an additional syllable and
`the first (Ne vs. Nur) and second
`syllables (o vs. es) sound different.
`
`Nouress will be used as an additive in
`amino acid/TPN solutions, which in
`
`(b)
`(4)
`
`(b)
`(4)
`
`

`

`No.
`
`POCA
`Score (%)
`
`Proposed name: Nouress
`Established name: cysteine
`hydrochloride, USP
`Dosage form: Injection
`Strength(s):
`500 mg/10 mL (50 mg/mL)
`Usual Dose: % of the total
`amino acids being supplied
`
`15.
`
`Norcet
`
` 64
`
`Prevention of Failure Mode
`
`In the conditions outlined below, the
`following combination of factors, are
`expected to minimize the risk of
`confusion between these two names
`
`clinical practice is considered a high
`alert medication requiring special
`safeguards in various points of the
`medication use process to reduce the
`risk of error. Furthermore, additives
`for TPN solutions are typically ordered
`by the established name (e.g.,
`cysteine) using a TPN prescription/
`order program and it is not anticipated
`that Nouress will be written on a
`medication order alone. Additionally,
`there are compatibility considerations
`with TPN solutions.
`Orthographically, the suffixes (cet vs.
`ess) look different. Phonetically, the
`second syllables (cet vs. es) sound
`different.
`
`The dose of Norcet is 1 to 2 tablets or
`capsules every 4 to 6 hours as needed.
`The dose of Nouress is dependent on
`the total amount of amino acids being
`supplied and weight-based ( % of
`total amino acids).
`
`Nouress will be used as an additive in
`amino acid/TPN solutions, which in
`clinical practice is considered a high
`alert medication requiring special
`safeguards in various points of the
`medication use process to reduce the
`risk of error. Furthermore, additives
`for TPN solutions are typically ordered
`by the established name (e.g.,
`cysteine) using a TPN prescription/
`order program and it is not anticipated