`RESEARCH
`
`
`APPLICATION NUMBER:
`
`209637Orig1s000
`
`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:
`February 17, 2017
`Application Type and Number: NDA 209637
`Product Name and Strength:
`Ozempic (semaglutide) injection,
`1.34 mg/mL
`2 mg/1.5 mL
`Single ingredient combination product (drug + device)
`Rx
`Novo Nordisk
`2016-11762660
`Susan Rimmel, PharmD
`Hina Mehta, PharmD
`
`Total Product Strength:
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Team Leader:
`
`Reference ID: 4059031
`
`
`
`1
`
`2
`
`Contents
`INTRODUCTION........................................................................................................1
`1.1
`Regulatory History................................................................................................1
`1.2
`Product Information ..............................................................................................1
`RESULTS.....................................................................................................................1
`2.1 Misbranding Assessment ......................................................................................1
`2.2
`Safety Assessment.................................................................................................2
`CONCLUSIONS..........................................................................................................4
`3.1
`Comments to the Applicant...................................................................................5
`REFERENCES.............................................................................................................6
`4
`APPENDICES .....................................................................................................................7
`
`3
`
`
`
`Reference ID: 4059031
`
`
`
`INTRODUCTION
`1
`This review evaluates the proposed proprietary name, Ozempic, 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 submitted an external name
`study, conducted by
`, for this product. We note that the external study
`provided in the current submission is the same study provided in the Applicant’s June 29, 2015,
`proprietary name submission for IND 79754 (OSE RCM # 2015-826232).
`
`REGULATORY HISTORY
`1.1
`The Applicant previously submitted the proposed proprietary name, Ozempic, on June 29, 2015.
`The Division of Medication Error Prevention and Analysis (DMEPA) found the name, Ozempic,
`acceptable on October 9, 2015.a
`
`PRODUCT INFORMATION
`1.2
`The following product information is provided in the December 6, 2016, proprietary name
`submission.
`Intended Pronunciation: oh-ZEM-pick
`
` Active Ingredient: semaglutide
`Indication of Use: an adjunct to diet and exercise to improve glycaemic control in
`
`adults with type 2 diabetes mellitus
` Route of Administration: subcutaneous
` Dosage Form: injection
` Strength: 2 mg/1.5 mL (1.34 mg/mL)
` Dose and Frequency: 0.25 mg once weekly for four weeks, then 0.5 mg once weekly for
`four weeks, then increase if needed to 1 mg once weekly
` How Supplied: three variants of a prefilled pen device each containing 2 mg/1.5 mL
`o Sample pack (1 pen) – delivers 0.25 mg, 0.5 mg
`o One pack (1 pen) – delivers 0.25 mg, 0.5 mg
`o Two pack (2 pens) – delivers 1 mg only
` Storage: When not in use, store at 2°C to 8°C (35.6°F to 46.4°F), not frozen and
`protected from light. When in use, store below 30°C (86°F), not
` frozen
`and protected from light.
`
`a Vee, S. Proprietary Name Review for Ozempic IND 79754. Silver Spring (MD): FDA, CDER, OSE, DMEPA
`(US); 2015 Oct 09. RCM No.: 2015-826232.
`
`Reference ID: 4059031
`
`1
`
`(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.
`
`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 Metabolism and
`Endocrinology Products (DMEP) 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 name.b
`
`2.2.2 Components of the Proposed Proprietary Name
`The Applicant did not provide a derivation or intended meaning for the proposed name,
`Ozempic, 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-eight 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. 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, December 23, 2016, e-mail, the Division of Metabolism and
`Endocrinology Products (DMEP) did not forward any comments or concerns relating to the
`proposed proprietary name at the initial phase of the review.
`
`b USAN stem search conducted on December 12, 2016.
`
`Reference ID: 4059031
`
`2
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`
`
`2.2.5 Phonetic and Orthographic Computer Analysis (POCA) Search Results
`Table 1 lists the number of names from our POCA search.c Our POCA search identified 43
`names with the combined score of ≥55%. We had identified and evaluated 89 names in our
`previous proprietary name review.d We re-evaluated the previously identified names of concern
`considering any lessons learned from recent post-marketing experience which may have altered
`our previous conclusion regarding the acceptability of the name. We note that none of the
`product characteristics have changed and we agree with the findings from our previous review
`for the names evaluated previously. Therefore, Table 1 lists the nine names not previously
`analyzed with the combined orthographic and phonetic score of ≥55% retrieved from our POCA
`search organized as highly similar, moderately similar, or low similarity for further evaluation.
`
`Table 1. Similarity Category
`
`Highly similar name pair:
`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%
`
`Number of
`Names
`1
`
`8
`
`0
`
`2.2.6 Names with Potential Orthographic, Spelling, and Phonetic Similarities that overlap in
`strength
`The proposed product, Ozempic, will be available in strength of 1.34 mg/mL. Since this is not a
`typical strength that is commonly marketed, we searched the Electronic Drug Registration and
`Listing System (eDRLS) databasee to identify any names with an overlap in strength and
`potential orthographic, spelling, and phonetic similarities with Ozempic that were not identified
`in POCA. Our search did not identify any new names since our previous review.
`
`2.2.7 Safety Analysis of Names with Potential Orthographic, Spelling, and Phonetic
`Similarities
`Our analysis of the nine names contained in Table 1 determined that none of the names will pose
`a risk for confusion as described in Appendices C through H.
`
`c POCA search conducted on December 13, 2016, in version 4.0. POCA tool updated to incorporate a revised
`orthographic algorithm.
`
`d Vee, S. Proprietary Name Review for Ozempic IND 79754. Silver Spring (MD): FDA, CDER, OSE, DMEPA
`(US); 2015 Oct 09. RCM No.: 2015-826232.
`
`e eDRLS search conducted on December 12, 2016.
`
`Reference ID: 4059031
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`3
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`
`
`2.2.8 Communication of DMEPA’s Analysis at Midpoint of Review
`DMEPA communicated our findings to the Division of Metabolism and Endocrinology Products
`(DMEP) via e-mail on February 9, 2017. At that time we also requested additional information
`or concerns that could inform our review. Per e-mail correspondence from the DMEP on
`February 16, 2017, they stated no additional concerns with the proposed proprietary name,
`Ozempic.
`
`3 CONCLUSIONS
`The proposed proprietary name is acceptable.
`If you have any questions or need clarifications, please contact Terrolyn Thomas, OSE project
`manager, at 240-402-3981.
`
`COMMENTS TO THE APPLICANT
`3.1
`We have completed our review of the proposed proprietary name, Ozempic, and have concluded
`that this name is acceptable.
`If any of the proposed product characteristics as stated in your December 6, 2016, submission are
`altered prior to approval of the marketing application, the name must be resubmitted for review.
`
`Reference ID: 4059031
`
`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.
`
`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.
`
`Reference ID: 4059031
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`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 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
`
`f National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors.html. Last accessed 10/11/2007.
`
`Reference ID: 4059031
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`
`
`*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 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)).
`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.
`
`Reference ID: 4059031
`
`7
`
`
`
`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 ≥55% to ≤69%.
`• 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 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.
`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
`
`Reference ID: 4059031
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`8
`
`
`
`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: 4059031
`
`9
`
`
`
`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: 4059031
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`10
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`
`
`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: 4059031
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`11
`
`
`
`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%).
`In most circumstances, these names are viewed as sufficiently different to minimize
`confusion. Exceptions to this would occur in circumstances where, for example, there
`are data that suggest a name with low similarity is nonetheless misinterpreted as a
`marketed product name in a prescription simulation study. In such instances, FDA
`would reassign a low similarity name to the moderate similarity category and review
`according to the moderately similar name pair checklist.
`
`Reference ID: 4059031
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`12
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`
`
`Appendix B: Prescription Simulation Samples and Results
`Figure 1. Ozempic Study (Conducted on December 20, 2016)
`
`Handwritten Medication Order/Prescription
`
`Medication Order:
`
`Outpatient Prescription:
`
`Verbal Prescription
`
`Ozempic
`Inject 1 mg subcutaneously
`once weekly
`Dispense # 1
`
`FDA Prescription Simulation Responses (Aggregate 1 Rx Studies Report)
`
`Study Name: Ozempic
`As of January 3, 2017
`Total
`INTERPRETATION
`AZEMBIC
`LOZEMPIC
`OSEMBIC
`OSEMBIK
`OSEMPIC
`OSENPIC
`
`306 People Received Study
`98 People Responded
`
`33
`OUTPATIENT
`0
`0
`0
`0
`0
`0
`
`26
`VOICE
`1
`1
`1
`1
`0
`0
`
`39
`INPATIENT
`0
`0
`0
`0
`4
`2
`
`TOTAL
`1
`1
`1
`1
`4
`2
`
`Reference ID: 4059031
`
`13
`
`
`
`OZEMBIC
`OZEMBIK
`OZEMBIQ
`OZEMPEK
`OZEMPIA
`OZEMPIC
`OZEMPIC 0.5 MG
`OZEMPICK
`OZEMPIK
`OZEMPIL
`OZEMPIO
`OZEMPIR
`OZEMPIZ
`OZEMYPIC
`OZEMYPIL
`OZEMYPIZ
`OZEMYTIZ
`OZENGIC
`OZENJPIZ
`OZENPIC
`OZENPIZ
`OZENSIZ
`OZENYP TL
`OZENYPIX
`OZENYPIZ
`OZERPIC
`OZIMPIC
`OZYMPIC
`
`0
`0
`0
`0
`1
`6
`0
`0
`0
`3
`0
`1
`3
`1
`1
`1
`1
`0
`1
`4
`4
`1
`1
`1
`2
`1
`0
`0
`
`3
`1
`1
`1
`0
`11
`0
`2
`1
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`1
`1
`
`0
`0
`0
`0
`1
`27
`1
`0
`0
`0
`1
`0
`0
`0
`0
`0
`0
`1
`0
`2
`0
`0
`0
`0
`0
`0
`0
`0
`
`3
`1
`1
`1
`2
`44
`1
`2
`1
`3
`1
`1
`3
`1
`1
`1
`1
`1
`1
`6
`4
`1
`1
`1
`2
`1
`1
`1
`
`Reference ID: 4059031
`
`14
`
`
`
`No.
`
`1.
`
`No.
`
`1.
`
`2.
`
`***
`
`3.
`
`Epzicom
`
`Appendix C: Highly Similar Names (e.g., combined or individual POCA score is ≥70%)
`Proposed name: Ozempic
`POCA
`Orthographic and/or phonetic differences in the
`Established name:
`Score
`names sufficient to prevent confusion
`semaglutide
`(%)
`Dosage form: injection
`Strength(s): 1.34 mg/mL
`Usual Dose: 0.5 mg or 1 mg
`once weekly
`Ozempic***
`
`100
`
`Subject of this review
`
`Other prevention of failure mode expected to
`minimize the risk of confusion between these two
`names.
`
`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
`N/A
`
`Appendix E: Moderately Similar Names (e.g., combined POCA score is ≥55% to ≤69%) with
`overlap or numerical similarity in Strength and/or Dose
`Proposed name: Ozempic
`POCA
`Prevention of Failure Mode
`Established name:
`Score
`semaglutide
`(%)
`Dosage form: injection
`Strength: 1.34 mg/mL
`Usual Dose: 0.5 mg or 1 mg
`once weekly
`Eczemin
`
`In the conditions outlined below, the following
`combination of factors, are expected to minimize the
`risk of confusion between these two names
`
`58
`
`Orthographic: The prefixes and suffixes of this name
`pair have sufficient orthographic differences. Ozempic
`has a downstroke in the 5th position while Eczemin does
`not.
`
`57
`
`54
`
`Phonetic: The first and third syllables of this name pair
`sound different.
`Orthographic: The prefixes and suffixes of this name
`pair have sufficient orthographic differences.
`
`Phonetic: The first and last syllables of this name pair
`sound different, and Ozempic has an extra syllable.
`Orthographic: The prefixes, infixes, and suffixes of this
`name pair have sufficient orthographic differences.
`
`Phonetic: The first and third syllables of this name pair
`sound different.
`
`Reference ID: 4059031
`
`15
`
`(b) (4)
`
`
`
`Appendix F: Low Similarity Names (e.g., combined POCA score is ≤54%)
`N/A
`Appendix G: Names not likely to be confused or not used in usual practice settings for the
`reasons described.
`N/A
`Appendix H: Names not likely to be confused due to notable spelling, orthographic and
`phonetic differences.
`No.
`
`Name
`
`POCA
`Score (%)
`56
`56
`56
`56
`55
`
`1.
`2.
`3.
`4.
`5.
`
`Femcet
`Zymecot
`Demi-Cof
`Cromoptic
`Piloptic, Piloptic-1/2, Piloptic-1,
`Piloptic-2, Piloptic-3, Piloptic-4,
`Piloptic-6
`
`Appendix I: Names identified in the eDRLS database not likely to be confused due to notable
`spelling, orthographic and phonetic differences.
`N/A
`
`Reference ID: 4059031
`
`16
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`SUSAN RIMMEL
`02/21/2017
`
`HINA S MEHTA
`02/22/2017
`
`Reference ID: 4059031
`
`
`
`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:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Team Leader:
`
`October 9, 2015
`IND 79754
`Ozempic (semaglutide) injection, 1.34 mg/mL
`(2 mg/1.5 mL)
`Combination Product (drug + device)
`Rx
`Novo Nordisk
`2015-826232
`Sarah K. Vee, PharmD
`Yelena Maslov, PharmD
`
`Reference ID: 3831632
`
`(b) (4)
`
`
`
`1
`
`2
`
`Contents
`INTRODUCTION........................................................................................................1
`1.1
`Product Information ..............................................................................................1
`RESULTS.....................................................................................................................1
`2.1 Misbranding Assessment ......................................................................................1
`2.2
`Safety Assessment.................................................................................................1
`CONCLUSIONS..................