CENTER FOR DRUG EVALUATION AND
`RESEARCH
`.
`
`APPLICA TION NUMBER:
`
`22-341
`
`PROPRIETARY NAME REVIEW! S)
`
`

`

`Department of Health and Human Services
`
`Public Health Service
`
` Office of Surveillance and Epidemiology
`
`Food and Drug Administration
`
`Center for Drug Evaluation and Research
`
`Date:
`
`To:
`
`Through:
`
`From:
`
`January 13, 2010
`
`Mary Parks, MD, Director
`Division of Metabolism and Endocrinology Products
`
`Carlos Mena—Grillasca, RPh, Team Leader
`Denise P. Toyer, PharmD, Deputy Director
`Division of Medication Error Prevention and Analysis (DMEPA)
`
`Walter Fava, R.Ph., Safety Evaluator
`Division of Medication Error Prevention and Analysis (DMEPA)
`
`Subject:
`
`Proprietary Name Review
`
`Drug Name(s):
`
`Victoza (Liraglutide) Injection
`18 mg/3 mL multiple dose prefilled pen
`
`Application Type/Number: NDA 022341
`
`Applicant:
`
`Novo Nordisk, Inc.
`
`OSE RCM #:
`
`2010-50
`
`

`

`CONTENTS
`
`bWNH
`
`INTRODUCTION ................................................................................................................... 3
`
`METHODS AND RESULTS .................................................................................................. 3
`
`CONCLUSIONS AND RECOMMENDATIONS .................................................................. 3
`
`REFERENCES ........................................................................................................................ 4
`
`

`

`1
`
`INTRODUCTION
`
`This re—assessment of the proprietary name is written in response to the anticipated approval of this NDA
`within 90 days from the date of this review. The Division of Medication Error Prevention and Analysis
`(DMEPA) found the proposed proprietary name, Victoza, acceptable in OSE Reviews #2008—220, dated
`July 20, 2009, and 2009—1696 dated October 20, 2009. The Division of Metabolism and Endocrinology
`Products did not have any concerns with the proposed name, Victoza, and the Division of Drug Marketing,
`Advertising and Communication (DDMAC) found the name acceptable from a promotional perspective on
`September 23, 2009.
`
`2 METHODS AND RESULTS
`
`For the proposed proprietary name, DMEPA staff search a standard set of databases and information sources
`(see section 4) to identify names with orthographic and/or phonetic similarity to the proposed name that have
`been approved since the previous proprietary name review. We used the same search criteria previously used in
`OSE Review #2008-220. Since none of the proposed product characteristics were altered we did not re-
`evaluate previous names of concern. Additionally, DMEPA searches the United States Adopted Names
`(USAN) stem list to determine if the name contains any USAN stems as of the last USAN updates. DMEPA
`bases the overall risk assessment on the findings of a Failure Mode and Effects Analysis (FMEA) of the
`proposed proprietary name, and focuses on the avoidance of medication errors.
`
`The searches of the databases referenced in Section 4 did not yield any new names thought to look or sound
`similar to Victoza and represent a potential source of drug name confusion.
`
`DMEPA staff did not identify any United States Adopted Names (USAN) stems in the proposed proprietary
`name, Victoza, as of January 12, 2010.
`
`3 CONCLUSIONS AND RECOMMENDATIONS
`
`The proprietary name risk assessment findings indicate that the proposed name, Victoza, is not vulnerable to
`name confusion that could lead to medication errors nor is the name considered promotional. Thus, the
`Division of Medication Error Prevention and Analysis (DMEPA) has no objection to the proprietary name,
`Victoza, for this product at this time.
`
`DMEPA considers this a final review; however, if approval of the NDA is delayed beyond 90 days from the
`date of this review, the Division of Metabolism and Endocrinology Products should notify DMEPA because the
`proprietary name must be re-reviewed prior to the new approval date.
`
`

`

`4 REFERENCES
`
`1.
`
`2.
`
`3.
`
`OSE review # 2008-220 dated July 20, 2009; Proprietary Name Review of Victoza; Walter Fava,
`Safety Evaluator.
`
`‘
`
`OSE review # 2009—1696 dated October 20, 2009; Proprietary Name Review of Victoza; Walter Fava,
`Safety Evaluator.
`
`Drugs@FDA (http://www. accessdatafda.gov/scrzpts/cder/dwgsatfda/index. cfm)
`
`Drugs@FDA contains most of the drug products approved 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, generic drugs, therapeutic
`biological products, prescription and over-the-counter human drugs and discontinued dlugs and “Chemical
`Type 6” approvals.
`
`4.
`
`USAN Stems (http://www.ama—assn.org/ama/pub/categ052/4 782.html)
`
`USAN Stems List contains all the recognized USAN stems.
`
`5.
`
`CDER Proposed Names List
`
`Compiled list of proposed proprietary names submitted to the Division of Medication Error Prevention and
`Analysis (DMEPA) for review. The list is updated weekly and maintained by DMEPA.
`
`

`

`Application
`Type/Number
`
`Submission
`Type/Number
`
`Submitter Name
`
`Product Name ‘
`
`NBA—22341
`
`ORlG—1
`'
`
`NOVO NORDISK
`INC
`
`VICTOZA (LIRAGLUTIDE)
`
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`‘
`
`. WALTER L FAVA
`
`01/13/2010
`
`CARLOS M MENA—GRILLASCA
`
`01/14/2010
`
`DENISE P TOYER
`
`01/14/2010
`
`

`

`
`
`Department of Health and Human Services
`
`Public Health Service
`
`Food and Drug Administration
`
`Center for Drug Evaluation and Research
`
`Office of Surveillance and Epidemiology
`
`Date:
`
`To:
`
`Through:
`
`From:
`
`October 20, 2009
`
`Mary Parks, MD, Director
`Division of Metabolism and Endocrinology Products
`
`Carlos Mena—Grillasca, RPh, Team Leader
`Denise P. Toyer, PharmD, Deputy Director
`Division of Medication Error Prevention and Analysis (DMEPA)
`
`Walter Fava, R.Ph., Safety Evaluator
`Division of Medication Error Prevention and Analysis (DMEPA)
`
`Subject:
`
`Proprietary Name Review
`
`Drug Name(s):
`
`Victoza (Liraglutide) Injection
`18 mg/3 mL multiple dose prefilled pen
`
`Application Type/Number: NDA 022341
`
`Applicant:
`
`Novo Nordisk, Inc.
`
`OSE RCM #:
`
`2009-1696
`
`

`

`CONTENTS
`
`-l>-Lr)l\.)v—‘
`
`INTRODUCTION ................................................................................................. ‘. ................. 3
`
`METHODS AND RESULTS .................................................................................................. 3
`
`CONCLUSIONS AND RECOMMENDATIONS .................................................................. 3
`REFERENCES ........................................................................................................................ 4
`
`

`

`1
`
`INTRODUCTION
`
`This re—assessment of the proprietary name is written in response to the anticipated approval of this NDA
`within 90 days from the date of this review. The Division of Medication Error Prevention and Analysis
`(DMEPA) found the proposed proprietary name, Victoza, acceptable in OSE Review #2008—220, dated July 20,
`2009. The Division of Metabolism and Endocrinology Products did not have any concerns with the proposed
`name, Victoza, and the Division of Drug Marketing, Advertising and Communication (DDMAC) found the
`name acceptable from a promotional perspective on September 23, 2009.
`
`2 METHODS AND RESULTS
`
`For the proposed proprietary name, DMEPA staff search a standard set of databases and information sources
`(see section 4) to identify names with orthographic and/or phonetic similarity to the proposed name that have
`been approved since the previous proprietary name review. We used the same search criteria previously used in
`OSE Review #2008—220 and since none of the proposed product characteristics were altered we did not re-
`evaluate previous names of concern. Additionally, DMEPA searches the United States Adopted Names
`(USAN) stem list to determine if the name contains any USAN stems as of the last USAN updates. DMEPA
`bases the overall risk assessment on the findings of a Failure Mode and Effects Analysis (FMEA) of the
`proposed proprietary name, and focuses on the avoidance of medication errors.
`
`The searches of the databases referenced in Section 4 did not yield any new names thought to look or sound
`similar to Victoza and represent a potential source of drug name confusion.
`
`DMEPA staff did not identify any United States Adopted Names (USAN) stems in the proposed proprietary
`name, Victoza, as of October 13, 2009.
`
`3
`
`CONCLUSIONS AND RECOMMENDATIONS
`
`The proprietary name risk assessment findings indicate that the proposed name, Victoza, is not vulnerable to
`name confusion that could lead to medication errors nor is the name considered promotional. Thus, the
`Division of Medication Error Prevention and Analysis (DMEPA) has no objection to the proprietary name,
`Victoza, for this product at this time.
`
`DMEPA considers this a final review; however, if approval of the NDA is delayed beyond 90 days from the
`date of this review, the Division of Metabolism and Endocrinology Products should notify DMEPA because the
`proprietary name must be re—reviewed prior to the new approval date.
`
`

`

`4 REFERENCES
`
`1.
`
`2.
`
`OSE review # 2008—220 Proprietary Name Review of Victoza; Walter Fava, Safety Evaluator.
`
`Drugs@FDA (http://www. accessdata. Zda. gov/scrszIS/cder/drugsa {fda/index. cfm)
`
`Drugs@FDA contains most of the drug products approved 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, generic drugs, therapeutic
`biological products, prescription and over—the-counter human drugs and discontinued drugs and “Chemical
`. Type 6” approvals.
`
`3.
`
`
`USAN Stems (http://www.ama-assn.org/ama/pub/categOQM 7821111111)
`
`USAN Stems List contains all the recognized USAN stems.
`
`4.
`
`CDER Proposed Names List
`
`Compiled list of proposed proprietary names submitted to the Division of Medication Error Prevention and
`Analysis (DMEPA) for review. The list is updated weekly and maintained by DMEPA.
`
`

`

`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`
`WALTER L FAVA
`
`10/21/2009
`
`CARLOS M MENA—GRILLASCA
`
`10/21/2009
`
`DENISE P TOYER
`
`10/23/2009
`
`

`

`
`
`Department of Health and Human Services
`
`Public Health Service
`
`Food and Drug Administration
`
`Center for Drug Evaluation and Research
`
`Office of Surveillance and Epidemiology
`
`July 20, 2009
`
`Mary Parks, M.D., Director
`Division of Metabolism and Endocrinology Products
`
`Kellie Taylor, MPH, PharmD.,Team Leader
`Denise Toyer, PharmD., Deputy Director
`Carol Holquist, R.Ph., Director
`Division of Medication Error Prevention and Analysis
`
`Walter Fava, R.Ph., Safety Evaluator
`Division of Medication Error Prevention and Analysis
`
`From:
`
`Subject:
`
`Proprietary Name Review
`
`W4)
`
`Victoza(lirag1utide) Injection
`
`W N
`
`DA: 22—341
`
`IND: 61,040
`
`NovoNordisk, Inc.
`
`2008—220
`2008—929
`
`Drug Name(s):
`
`Application Type/Number:
`
`Sponsor:
`
`0813 RCM #:
`
`WThis document contains proprietary drug use data obtained by FDA under contract. The ding
`use data/information cannot be released to the public/non-FDA personnel without contractor
`approval obtained through the FDA/CDER Office of Surveillance and Epidemiology.*
`
`

`

`CONTENTS
`
`EXECUTIVE SUMMARY ............................................................................................................. 3
`1
`BACKGROUND ..................................................................................................................... 3
`
`1 . 1
`
`1.2
`
`Introduction .................................................................................................................... 3
`
`Product Information ....................................................................................................... 3
`
`2 METHODS AND MATERIALS ............................................................................................ 3
`
`Proprietary Name Risk Assessment ............................................................................... 4
`2.1
`RESULTS ................................................................................................................................ 9
`
`Proprietary Name Risk Assessment ............................................................................... 9
`3.1
`DISCUSSION ....................................................................................................................... 11
`
`CONCLUSIONS And Recommendations ............................................................................. 11
`
`Comments to the Applicant.......................................................................................... 11
`5.1
`REFERENCES ........... ‘. .......................................................................................................... 12
`
`3
`
`4
`
`5
`
`6
`
`APPENDICES ............................................................................................................................... 14
`
`

`

`EXECUTIVE SUMMARY
`
`Victoza is the proposed proprietary name for liraglutide injection. This proposed name was evaluated
`from a safety and promotional perspective based on the product characteristics provided by the Applicant.
`We sought input from pertinent disciplines involved with the review of this application and considered it
`accordingly. Our evaluation did not identify concems that would render the name unacceptable based on
`the product characteristics and safety profile known at the time of this review. Thus, DMEPA finds the
`proposed proprietary name Victoza conditionally acceptable for this product. The proposed proprietary
`name must be re-reviewed upon submission of the NDA and 90 days before approval of the NDA.
`
`Additionally, if any of the proposed product characteristics as stated in this review are altered, DMEPA
`rescinds this finding and the name must be resubmitted for review. The conclusions upon re-review are
`subject to change.
`
`1
`
`BACKGROUND
`
`1.1
`
`INTRODUCTION
`
`W)
`
`This review was written in response to a request from the Division of Metabolism and Endocrinology
`Products, to evaluate the product for its potential to contribute to medication errors. The proposed name,
`Victoza, is evaluated to determine if the name could potentially be confused with other proprietary or
`established drug names. The Applicant submitted an independent analysis of the name by the p:-
`""
`,a subsidiary of theKm for review and comment Container (pen)
`labels, carton and insert labeling were also provided to evaluate from a medications errors perspective and
`review comments will be provided under separate cover in a forthcoming review (OSE #: 2008- 1096).
`
`1.2
`
`PRODUCT INFORMATION
`
`Victoza (Liraglutide) is a long-acting derivative of the naturally occurring intestinal hormone, glucagon-
`like peptide—l (GLP-l). Liraglutide is a selective GLP-l agonist, with a high potency at the human GLP-
`1 receptor. It is proposed to be indicated as an adjunct to diet and exercise to improve glycemic control in
`patients with type 2 diabetes mellitus. It is administered as a subcutaneous injection once daily at any
`time during the day. The recommended initial dose is 0.6 mg as monotherapy or as combination therapy.
`The dose can be increased in one week intervals to 1.2 mg per day, then up to a maximum dose of 1.8 mg
`once daily.
`
`Victoza1s provided1n pre-filled disposable pen injectors with a 3 mL cartridge1n a concentration of
`6 mg/mL.
`
`
`
`M43
`
`2 METHODS AND MATERIALS
`
`This section describes the methods and materials used by the Division of Medication Error Prevention
`and Analysis staff conducting a proprietary name risk assessment (see section 2.1). The primary focus of
`the assessment is to identify and remedy potential sources of medication error prior to drug approval. The
`Division of Medication Error Prevention and Analysis defines a medication error as any preventable event
`
`

`

`that may cause or lead to inappropriate medication use or patient harm while the medication is in the
`control of the health care professional, patient, or consumer. ‘
`
`2.1
`
`PROPRIETARY NAME RISK ASSESSMENT
`
`FDA’s Proprietary Name Risk Assessment considers the potential for confusion between the proposed
`proprietary name, Victoza, and the proprietary and established names of drug products existing in the
`marketplace and those pending IND, BLA, NDA, and ANDA products currently under review by CDER.
`
`For the proprietary name, Victoza, the DMEPA staff search a standardiset of databases and information
`sources to identify names with orthographic and phonetic similarity (see Sections 2.1.1 for detail) and
`held an CDER Expert Panel discussion to gather professional opinions on the safety of the proposed
`proprietary name (see 2.1.1.2). We also conduct internal CDER prescription analysis studies (see 2.1.2),
`and, when provided, external prescription analysis studies results are considered and incorporated into the
`overall risk assessment (see detail 2.1.4).
`
`The Safety Evaluator assigned to the Proprietary Name Risk Assessment is responsible for considering
`the collective findings, and provides an overall risk assessment of the proposed proprietary name (see
`detail 2.1.4). The overall risk assessment is based on the findings of a Failure Mode and Effects Analysis
`(FMEA) of the proprietary name, and is focused on the avoidance of medication errors. FMEA is a
`systematic tool for evaluating a process and identifying where and how it might fail. 2 FMEA is used to
`analyze whether the drug names identified with look- or sound-alike similarity to the proposed name
`could cause confusion that subsequently leads to medication errors in the clinical setting. We use the
`clinical expertise of the DMEPA staff to anticipate the conditions of the clinical setting that the product is
`likely to be used in based on the characteristics of the proposed product.
`
`In addition, the product characteristics provide the context for the verbal and written communication of
`the drug names and can interact with the orthographic and phonetic attributes of the names to increase the
`risk of confusion when there is overlap, or, in some instances, decrease the risk of confusion by helping to
`differentiate the products through dissimilarity. As such, the staff consider the product characteristics
`associated with the proposed drug throughout the risk assessment, since the product characteristics of the
`proposed name may provide a context for communication of the drug name and ultimately determine the
`use of the product in the usual clinical practice setting.
`
`Typical product characteristics considered when identifying drug names that could potentially be
`confused with the proposed drug name include, but are not limited to established name of the proposed
`product, the proposed indication, dosage form, route of administration, strength, unit of measure, dosage
`units, recommended dose, typical quantity or volume, frequency of administration, product packaging,
`storage conditions, patient population, and prescriber population. Because drug name confusion can occur
`at any point in the medication use process, we consider the potential for confusion throughout the entire
`US. medication use process, including drug procurement, prescribing and ordering, dispensing,
`administration, and monitoring the impact of the medication.3
`
`2.1.1 Search Criteria
`
`The DMEPA staff consider the spelling of the name, pronunciation of the name when spoken, and
`appearance of the name when scripted as outlined in Appendix A.
`
`
`I National Coordinating Council for Medication Error Reporting and Prevention.
`http://www.nccmerporg/aboutMedErrorshtml. Last accessed 10/11/2007.
`
`2 Institute for Healthcare Improvement (1H1). Failure Modes and Effects Analysis. Boston. lle2004.
`
`3 Institute ofMedicine. Preventing Medication Errors. The National Academies Press: Washington DC. 2006.
`
`

`

`For this review, particular consideration was given to drug names beginning with the letter ‘V’ when
`searching to identify potentially similar drug names, as 75% of the confused drug names reported by the
`ISMP Medication Error Reporting Program involve pairs beginning with the same letter.45
`
`To identify drug names that may look similar to Victoza, DMEPA staff also consider the other
`orthographic appearance of the name on lined and unlined orders. Specific attributes taken into
`consideration include the length of the name (7 letters), upstrokes (2, capital letter ‘V’ and lower case
`letter ‘t’), downstrokes (one or none, depending on how the letter ‘2’ is scripted), cross-strokes (one letter,
`‘t’), and dotted letters (one letter, ‘i’). Additionally, several letters in Victoza may be vulnerable to
`ambiguity when scripted, including the letter ‘V’ which may appear as the letters ‘U’, ‘N’, ‘L’, ‘2’ or ‘C’;
`the lower case letter ‘i’ may appear as a lower case ‘_e’, ‘r’, or ‘u’; and ‘—oza’ may appear as ‘-ozo’, ‘-azo’,
`‘—aza’, ‘-oyo’, ‘-oya’, ‘—aya’, ‘-ogo’, ‘—ago’, ‘-oga’, ‘-aga’. As such, the staff also consider these alternate
`appearances when identifying drug names that may look similar to Victoza.
`
`When searching to identify potential names that may sound similar to Victoza, the staff search for names
`with similar number of syllables (3), stresses (vic-TO-za or VIC-to-ZA), and placement of vowel and
`consonant sounds. Additionally,
`the DMEPA staff considers that pronunciation of parts of the name can
`vary such as ‘Vic’ may sound like ‘Vike’, ‘Bic’, ‘Vuc’, ‘Vec’; and ‘to’ may sound like ‘too’. The
`Applicant did not provide their intended pronunciation of the proprietary name in the proposed name
`submission and, therefore, it could not be taken into consideration. Moreover, names are often
`mispronounced and/or spoken with regional accents and dialects, so other potential pronunciations of the
`name are considered.
`
`The staff also consider the product characteristics associated with the proposed drug throughout the
`identification of similar drug names, since the product characteristics of the proposed drug ultimately
`determine the use of the product in the clinical practice setting For this review, the staff were provided
`with the following information about the proposed product:
`the proposed proprietary name (Victoza), the
`established name (liraglutide), proposed indication (Type II Diabetes), strength (1.2 mg, 1.8 mg), dose
`(1.2 mg daily, titrate up to 1.8 mg daily based on clinical response), frequency of administration (daily),
`route (parenteral) and dosage form of the product (injection). Appendix A provides a more detailed
`listing of the product characteristics the medication error generally take into consideration.
`
`Lastly, the DMEPA staff also consider the potential for the proposed name to inadvertently function as a
`source of error for reasons other than name confusion. Post-marketing experience has demonstrated that
`proprietary names (or components of the proprietary name) can be a source of error in a variety of ways.
`As such, these broader safety implications of the name are considered and evaluated throughout this
`assessment and the DMEPA provide additional comments related to the safety of the proposed name or
`product based on their professional experience with medication errors.
`
`2.1.1.1 Database and Information Sources
`
`The proposed proprietary name, Victoza, was provided to the DMEPA staff to conduct a search of the
`intemet, several standard published drug product reference texts, and FDA databases to identify existing
`and proposed drug names that may sound-alike or look-alike to Victoza using the criteria outlined in
`2.1.1. A standard description of the databases used in the searches is provided in Section 7. To
`complement the process, the DMEPA staff use a computerized method of identifying phonetic and
`orthographic similarity between medication names. The program, Phonetic and Orthographic Computer
`
`4 Institute for Safe Medication Practices. Confused Drug name List (1996-2006). Available at
`http://www.ismp.org/Tools/confuseddrugnamespdf
`5 Kondrack, G and Dorr, B. Automatic Identification,ofConfusable Drug'Names. Artifical lnteligence in Medicine iv
`(2005)
`
`

`

`Analysis (POCA), uses complex algorithms to select a list of names from a database that have some
`similarity (phonetic, orthographic, or both) to the trademark being evaluated. Lastly, the DMEPA staff
`reviews the United States Adopted Names (USAN) stem list to determine if any USAN stems are present
`within the proprietary name. The findings of the individual Safety Evaluators were then pooled and
`presented to the Expert Panel.
`
`2.1.1.2 CDER Expert Panel Discussion
`
`An Expert Panel Discussion is held by DMEPA to gather CDER professional opinions on the safety of
`the product and the proprietary name, Victoza. Potential concerns regarding drug marketing and
`promotion related to the proposed names are also discussed. This group is composed of DMEPA staff and
`representatives from the Division of Drug Marketing, Advertising, and Communications (DDMAC).
`
`The pooled results of the staff were presented to the Expert Panel for consideration. Based on the clinical
`and professional experiences of the Expert Panel members, the Panel may recommend the addition of
`names, additional searches by the Safety Evaluator to supplement the pooled results, or general advice to
`consider when reviewing the proposed proprietary name.
`
`2.1.2 CDER Prescription Analysis Studies
`
`Three separate studies are conducted within the Centers of the FDA for the proposed proprietary name to
`determine the degree of confusion of Victoza with marketed US. drug names (proprietary and
`established) due to similarity in Visual appearance with handwritten prescriptions or verbal pronunciation
`of the drug name. The studies employ a total of 123 healthcare professionals (pharmacists, physicians,
`and nurses), and attempts to simulate the prescription ordering process. The results are used by the Safety
`Evaluator to identify any orthographic or phonetic vulnerability of the proposed name to be
`misinterepreted by healthcare practitioners.
`
`
`ach 13 2008
`
`In order to evaluate the potential for misinterpretation of Victoza in handwriting and verbal
`communication of the name, inpatient medication orders and outpatient prescriptions are written, each
`consisting of a combination of marketed and unapproved drug products, including the proposed name.
`These prescriptions are optically scanned and one prescription is delivered to a random sample of 123
`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 send their interpretations of the orders via e-mail to the DMEPA staff.
`
`
`
`
`Fi_ure 1. Victza Stud
`conducted on
`
`HANDWRITTENPRESCRIPITON AND MEDICATION ORDER
`
`i
`
`'
`
`_.
`
`VERBAL PRESCRIPTION
`
`Outpatient Prescription:
`
`Victoza #1
`
`Inject 0.6 mg under the skin once
`daily.
`
`
`
`

`

`2.1.3 External Proprietary Name Risk Assessment
`
`For this product, the Applicant submitted an independent risk assessment of the proposed proprietary
`name conducted by a consulting firm. DMEPA conducts an independent analysis and evaluation of the
`data provided, and responds to the overall findings of the assessment. When the external proprietary
`name risk assessment idenifies potentially confusing names that were not captured in the DMEPA ‘s
`database searches or in the Expert Panel Discussion, these names are included in the Safety Evaluator’s
`Risk Assessment and analyzed independently by the Safety Evaluator to determine if the potentially
`confusing name could lead to medication errors in the usual practice settings.
`
`After the Safety Evaluator has determined the overall risk assessment of the proposed name, the Safety
`Evaluator compares the findings with their overall risk assessment with the findings of the proprietary
`name risk assessment submitted by the Applicant. The Safety Evaluator then determines whether
`DMEPA’s risk assessment concurs with the findings. When the proprietary name risk assessments differ,
`DMEPA provides a detailed explanation of the differences.
`
`2.1.4 Comments from the Division ofMetabolism and Endocrinology Products
`
`DMEPA requests the regulatory division in the Office of New Drugs responsible for the application for
`their comments or concerns with the proposed proprietary name and 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 DDMAC’s decision on the name. Any
`comments or concerns are addressed in the safety evaluator’s assessment.
`
`The 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 regulatory division
`is requested to concur /not concur with DMEPA’s final decision.
`
`2.1.5 Safety Evaluator Risk Assessment of the Proposed Proprietary Name
`
`Based on the criteria set forth in Section 2.1.1, the Safety Evaluator Risk Assessment applies their
`individual expertise gained from evaluating medication errors reported to FDA to conduct a Failure Mode
`and Effects Analysis and provide an overall risk of name confusion. Failure Mode and Effects Analysis
`(FMEA) is a systematic tool for evaluating a process and identifying where and how it might fail.6 When
`applying FMEA to assess the risk of a proposed proprietary name, DMEPA seeks to evaluate the potential
`for aproposed name to be confused with another drug name as a result of the name confusion and cause
`errors to occur in the medication use system. FMEA capitalizes on the predictable and preventable nature
`of medication errors associated with drug name confusion. FMEA allows the Agency to identify the
`potential for medication errors due to look- or sound-alike drug names prior to approval, where actions to '
`overcome these issues are easier and more effective then remedies available in the post-approval phase.
`
`In order to perform an FMEA of the proposed name, the Safety Evaluator must analyze the Use of the
`product at all points in the medication use system. Because the proposed product is not yet marketed, the
`Safety Evaluator anticipates the use of the product in the usual practice settings by considering the clinical
`and product characteristics listed in Appendix A. The Safety Evaluator then analyzes the proposed
`proprietary name in the context of the usual practice setting and works to identify potential failure modes
`and the effects associated with the failure modes.
`
`_
`
`In the initial stage of the Risk Assessment, the Safety Evaluator compares the proposed proprietary name
`to all of the names gathered from the above searches, expert panel evaluation, and studies, and identifies
`potential failure modes by asking: “Is the name Victoza convincing similar to another drug name, which
`
`6 Institute for Healthcare Improvement (ll-ll). Failure Modes and Effects Analysis. Boston. ll-Il:2004.
`
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`may cause practitioners to become confused at any point in the usual practice setting?” An affirmative
`answer indicates a failure mode and represents a potential for Victoza to be confiised with another
`proprietary or established drug name because of look— or sound-alike similarity. If the answer to the
`question is no, the Safety Evaluator is not convinced that the names possess similarity that would cause .
`confusion at any point in the medication use system and the name is eliminated from further review.
`
`In the second stage of the Risk Assessment, all potential failure modes are evaluated to determine the
`likely efi’ect of the drug name confusion, by asking “Could the confusion of the drug names conceivably
`result in medication errors in the usual practice setting?” The answer to this question is a central
`component of the Safety Evaluator’s overall risk assessment of the proprietary name. If the Safety
`Evaluator determines through FMEA that the name similarity would ultimately not be a source of
`medication errors in the usual practice setting, the name is eliminated from further analysis. However, if
`the Safety Evaluator determines through FMEA that the name similarity could ultimately cause
`medication errors in the usual practice setting, the Safety Evaluator will then recommend that an alternate
`proprietary name be used.
`In rare instances, the FMEA findings may provide other risk—reduction
`strategies, such as product reformulation to avoid an overlap in strength or an alternate modifier
`designation may be recommended as a means of