CENTER FOR DRUG EVALUATION AND
RESEARCH
APPLICATION NUMBER:

205718Orig1s000
PROPRIETARY NAME REVIEW(S)

 Department of Health and Human Services
Public Health Service
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Surveillance and Epidemiology
Office of Medication Error Prevention and Risk Management
Proprietary Name Review
Date:

December 12, 2013

Reviewer:

Lisa Vo Khosla, PharmD, M.H.A.
Division of Medication Error Prevention and Analysis

Team Leader:

Lubna Merchant, PharmD, M.S.
Division of Medication Error Prevention and Analysis

Drug Name(s) and Strength(s):

Akynzeo (Netupitant and Palonosetron) Capsules,
300 mg/0.5 mg

Application Type/Number:

NDA 205718

Applicant/Sponsor:

Helsinn Healthcare, SA

OSE RCM #:

2013-2310

*** This document contains proprietary and confidential information that should not be
released to the public.***
**This document contains proprietary drug use data obtained by FDA under contract.
The drug 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.**

Reference ID: 3421195

 CONTENTS
1

INTRODUCTION................................................................................................................... 1
1.1
Regulatory History .......................................................................................................... 1
1.2
Product Information......................................................................................................... 1
2 RESULTS................................................................................................................................ 1
2.2
Safety Assessment ........................................................................................................... 2
3 CONCLUSIONS ..................................................................................................................... 3
3.1
Comments to the Applicant ............................................................................................. 3
4 REFERENCES ........................................................................................................................ 4
APPENDICES................................................................................................................................. 7

Reference ID: 3421195

 1

INTRODUCTION

This review evaluates the proposed proprietary name, Akynzeo, from a safety and
promotional perspective. The sources and methods used to evaluate the proposed name
are outlined in the reference section and Appendix A respectively.
1.1

REGULATORY HISTORY

DMEPA previously reviewed the proposed proprietary name, Akynzeo, under IND
073493 (OSE Review # 2011-2311 dated December 8, 2011), and found the name
conditionally acceptable. On October 8, 2013, Helsinn Healthcare, SA submitted a
request to the Agency for a re-assessment of the proposed proprietary name, Akynzeo,
under NDA 205718.
1.2

PRODUCT INFORMATION

The following product information is provided in the October 8, 2013 proprietary name
submission.


Active Ingredient: Netupitant and Palonosetron



Indication of Use:
o 1) Prevention of acute and delayed nausea and vomiting associated with
initial and repeat courses of highly emetogenic cancer chemotherapy
o 2) Prevention of acute and delayed nausea and vomiting associated with
initial and repeat courses of moderately emetogenic chemotherapy

2



Route of Administration: Oral



Dosage Form: Capsules



Strength: 300 mg/0.5 mg



Dose and Frequency: One capsule prior to each chemotherapy cycle.



How Supplied: Single capsule packaged in
Each blister card is packaged individually in a carton.



Storage: Room Temperature

(b) (4)

blister card.

RESULTS

The following sections provide the information obtained and considered in the overall
evaluation of the proposed proprietary name.
2.1

PROMOTIONAL ASSESSMENT

The Office of Prescription Drug Promotion OPDP determined the proposed name is
acceptable from a promotional perspective. DMEPA and the Division of
Gastroenterology and Inborn Error Products (DGIEP) concurred with the findings of
OPDP’s promotional assessment of the proposed name.

Reference ID: 3421195

1

 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

The October 22, 2013 search of the United States Adopted Name (USAN) stems did not
identify that a USAN stem is present in the proposed proprietary name.
2.2.2

Components of the Proposed Proprietary Name

The Applicant indicated in their submission that the proposed name, Akynzeo, has no
intended meaning. 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.
2.2.4

FDA Name Simulation Studies

Fifty-nine practitioners participated in DMEPA’s prescription studies. The
interpretations did not overlap with any currently marketed products nor did the
misinterpretations sound or look similar to any currently marketed products or any
products in the pipeline. Eighteen participants from the outpatient prescription studies,
and five participants from the inpatient prescription studies interpreted the name correctly
as Akynzeo. The remaining thirty-six participants interpreted the name incorrectly with
nine misinterpretations occurring in the inpatient prescription studies, in which the
participants misinterpreted the letters “yn” as the letter “ep”, and six misinterpretations
occurring in the voice prescription studies, in which the participants misinterpreted the
letter “y” as the letter “i”, and the letter “e” as the letter “i”. We have considered these
variations in our look-alike and sound-alike searches and analysis (See Appendix B).
Appendix C contains the results from the verbal and written prescription studies.
2.2.5

Comments from Other Review Disciplines at Initial Review

In response to the OSE, October 31, 2013 e-mail, the Division of Gastroenterology and
Inborn Error Products (DGIEP) did not forward any comments or concerns relating to the
proposed name at the initial phase of the proprietary name review.
2.2.6

Failure Mode and Effects Analysis of Similar Names

Appendix B lists possible orthographic and phonetic misinterpretations of the letters
appearing in the proposed proprietary name, Akynzeo. We note that there was no change
in product characteristics for Akynzeo. We did not identify any names of concern upon
re-evaluation. Table 1 list names which were not initially identified and evaluated in
OSE Review #2011-2311 dated December 8, 2011. Table 1 also includes the names
(b) (4)
identified from
not identified by DMEPA and requires further evaluation.

Reference ID: 3421195

2

 Table 1: Collective List of Potentially Similar Names (DMEPA, EPD, Other Disciplines, and

External Name Study)
Look Similar
Name Source Name Source Name Source
FDA Axiron FDA Kynamro FDA
Astringyn FDA

Our analysis of the 4 names contained in Table 1 determined none of the names will pose
a risk for confusion as described in Appendices through E.

2.2. 7 Communication of DMEPA ?s Analysis at Midpoint of Review

DMEPA our ?ndings to the Division of Gastroenterology and Inborn
Error Products (DGIEP) via e-mail on December 4, 2013. At that time we also requested
additional information or concerns that could inform our review. The Division of
Gastroenterology and Inborn Error Products (DGIEP) concmred with our assessment of
the proposed proprietary name, Akynzeo.

3 CONCLUSIONS

The proposed proprietary name is acceptable from both a promotional and safety
perspective.

If you have further questions or need clarifications, please contact Phong Do, OSE
project manager, at 301-796-4795.
3.1 COMMENTS TO THE APPLICANT

We have completed our review of the proposed proprietary name, Akynzeo, and have
concluded that this name is acceptable.

If any of the proposed product characteristics as stated in your October 8. 2013 submission
are altered, the name must be resubmitted for review.

Reference ID: 3421195 3

4

REFERENCES

1. Micromedex Integrated Index (http://csi.micromedex.com)
Micromedex contains a variety of databases covering pharmacology, therapeutics,
toxicology and diagnostics.
2. Phonetic and Orthographic Computer Analysis (POCA)
POCA is a database which was created for the Division of Medication Error
Prevention and Analysis, FDA. As part of the name similarity assessment, proposed
names are evaluated via a phonetic/orthographic algorithm. The proposed proprietary
name is converted into its phonemic representation before it runs through the phonetic
algorithm. Likewise, an orthographic algorithm exists which operates in a similar
fashion.
3. Drug Facts and Comparisons, online version, St. Louis, MO
(http://factsandcomparisons.com)
Drug Facts and Comparisons is a compendium organized by therapeutic course; it
contains monographs on prescription and OTC drugs, with charts comparing similar
products. This database also lists the orphan drugs.
4. FDA Document Archiving, Reporting & Regulatory Tracking System [DARRTS]
DARRTS is a government database used to organize Applicant and Sponsor
submissions as well as to store and organize assignments, reviews, and
communications from the review divisions.
5. 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.
6. Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/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 overthe-counter human drugs and discontinued drugs and “Chemical Type 6” approvals.

7. U.S. Patent and Trademark Office (http://www.uspto.gov)
USPTO provides information regarding patent and trademarks.
8. Clinical Pharmacology Online (www.clinicalpharmacology-ip.com)
Clinical Pharmacology contains full monographs for the most common drugs in
clinical use, plus mini monographs covering investigational, less common,

Reference ID: 3421195

4

 combination, nutraceutical and nutritional products. It also provides a keyword search
engine.
9.

Data provided by Thomson & Thomson’s SAEGIS ™ Online Service, available at
(www.thomson-thomson.com)
The Pharma In-Use Search database contains over 400,000 unique pharmaceutical
trademarks and trade names that are used in about 50 countries worldwide. The data
is provided under license by IMS HEALTH.

10. Natural Medicines Comprehensive Databases (www.naturaldatabase.com)
Natural Medicines contains up-to-date clinical data on the natural medicines, herbal
medicines, and dietary supplements used in the western world.
11. Access Medicine (www.accessmedicine.com)
Access Medicine® from McGraw-Hill contains full-text information from
approximately 60 titles; it includes tables and references. Among the titles are:
Harrison’s Principles of Internal Medicine, Basic & Clinical Pharmacology, and
Goodman and Gilman’s The Pharmacologic Basis of Therapeutics.
12. USAN Stems (http://www.ama-assn.org/ama/pub/about-ama/our-people/coalitionsconsortiums/united-states-adopted-names-council/naming-guidelines/approvedstems.shtml)
USAN Stems List contains all the recognized USAN stems.
13. Red Book (www.thomsonhc.com/home/dispatch)
Red Book contains prices and product information for prescription, over-the-counter
drugs, medical devices, and accessories.
14. Lexi-Comp (www.lexi.com)
Lexi-Comp is a web-based searchable version of the Drug Information Handbook.
15. Medical Abbreviations (www.medilexicon.com)
Medical Abbreviations dictionary contains commonly used medical abbreviations and
their definitions.
16. CVS/Pharmacy (www.CVS.com)
This database contains commonly used over the counter products not usually
identified in other databases.
17. Walgreens (www.walgreens.com)
This database contains commonly used over the counter products not usually
identified in other databases.

Reference ID: 3421195

5

 18. Rx List (www.rxlist.com)
RxList is an online medical resource dedicated to offering detailed and current
pharmaceutical information on brand and generic drugs.
19. Dogpile (www.dogpile.com)
Dogpile is a Metasearch engine that searches multiple search engines including
Google, Yahoo! and Bing, and returns the most relevant results to the search.
20. Natural Standard (http://www.naturalstandard.com)
Natural Standard is a resource that aggregates and synthesizes data on complementary
and alternative medicine.

Reference ID: 3421195

6

 APPENDICES
Appendix A
FDA’s Proprietary Name Risk Assessment considers the promotional and safety aspects
of a proposed proprietary name. The promotional review of the proposed name is
conducted by OPDP. OPDP evaluates proposed proprietary names to determine if they
are overly fanciful, so as to misleadingly imply unique effectiveness or composition, as
well as to assess whether they contribute to overstatement of product efficacy,
minimization of risk, broadening of product indications, or making of unsubstantiated
superiority claims. OPDP provides their opinion to DMEPA for consideration in the
overall acceptability of the proposed proprietary name.
The safety assessment is conducted by DMEPA. DMEPA staff search a standard set of
databases and information sources to identify names that are similar in pronunciation,
spelling, and orthographically similar when scripted to the proposed proprietary name.
Additionally, 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.).
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. 1
Following the preliminary screening of the proposed proprietary name, DMEPA gathers
to discuss their professional opinions on the safety of the proposed proprietary name.
This meeting is commonly referred to the Center for Drug Evaluation and Research
(CDER) Expert Panel discussion. DMEPA also considers other aspects of the name that
may be misleading from a safety perspective. DMEPA staff conducts a prescription
simulation studies using FDA health care professionals. 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. DMEPA bases the overall risk assessment
on the findings of a Failure Mode and Effects Analysis (FMEA) of the proprietary name
and misleading nature of the proposed proprietary name with a focus on the avoidance of
medication errors.
DMEPA uses the clinical expertise of its staff to anticipate the conditions of the clinical
setting where the product is likely to be used based on the characteristics of the proposed
product. DMEPA considers the product characteristics associated with the proposed
product throughout the risk assessment because the product characteristics of the

1

National Coordinating Council for Medication Error Reporting and Prevention.
http://www nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.

Reference ID: 3421195

7

 proposed 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 proprietary name include, but are not limited
to; established name of the proposed product, proposed indication of use, 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. DMEPA considers how these
product characteristics may or may not be present in communicating a product name
throughout the medication use system. Because drug name confusion can occur at any
point in the medication use process, DMEPA considers the potential for confusion
throughout the entire U.S. medication use process, including drug procurement,
prescribing and ordering, dispensing, administration, and monitoring the impact of the
medication.2
The DMEPA considers the spelling of the name, pronunciation of the name when spoken, and
appearance of the name when scripted. DMEPA compares the proposed proprietary name
with the proprietary and established name of existing and proposed drug products and names
currently under review at the FDA. DMEPA compares the pronunciation of the proposed
proprietary name with the pronunciation of other drug names because verbal communication
of medication names is common in clinical settings. DMEPA examines the phonetic
similarity using patterns of speech. If provided, DMEPA will consider the Sponsor’s intended
pronunciation of the proprietary name. However, DMEPA also considers a variety of
pronunciations that could occur in the English language because the Sponsor has little control
over how the name will be spoken in clinical practice. The orthographic appearance of the
proposed name is evaluated using a number of different handwriting samples. DMEPA
applies expertise gained from root-cause analysis of postmarketing medication errors to
identify sources of ambiguity within the name that could be introduced when scripting
(e.g.,“T” may look like “F,” lower case ‘a’ looks like a lower case ‘u,’ etc). Additionally,
other orthographic attributes that determine the overall appearance of the drug name when
scripted (see Table 1 below for details).

2

Institute of Medicine. Preventing Medication Errors. The National Academies Press: Washington DC.
2006.

Reference ID: 3421195

8

 Table 1. Criteria Used to Identify Drug Names that Look- or Sound-Similar to a
Proposed Proprietary Name.
Considerations when Searching the Databases
Type of
Similarity

Potential
Causes of Drug
Name
Similarity

Attributes Examined to Identify
Similar Drug Names

Similar spelling

Identical prefix
Identical infix
Identical suffix
Length of the name
Overlapping product
characteristics

 Names may appear similar
in print or electronic media
and lead to drug name
confusion in printed or
electronic communication

Orthographic
similarity

Similar spelling
Length of the name/Similar
shape
Upstrokes
Down strokes
Cross-strokes
Dotted letters
Ambiguity introduced by
scripting letters
Overlapping product
characteristics

 Names may look similar
when scripted, and lead to
drug name confusion in
written communication

Phonetic
similarity

Identical prefix
Identical infix
Identical suffix
Number of syllables
Stresses
Placement of vowel sounds
Placement of consonant sounds
Overlapping product
characteristics

 Names may sound similar
when pronounced and lead
to drug name confusion in
verbal communication

Lookalike

Soundalike

Potential Effects

 Names may look similar
when scripted and lead to
drug name confusion in
written communication

Lastly, DMEPA considers the potential for the proposed proprietary name to
inadvertently function as a source of error for reasons other than name confusion. Postmarketing experience has demonstrated that proprietary names (or components of the
proprietary name) can be a source of error in a variety of ways. Consequently, DMEPA
considers and evaluates these broader safety implications of the name throughout this
assessment and the medication error staff provides additional comments related to the

Reference ID: 3421195

9

 safety of the proposed proprietary name or product based on professional experience with
medication errors.
1. Database and Information Sources
DMEPA searches the internet, 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 the proposed proprietary name. A standard description of the databases
used in the searches is provided in the reference section of this review. To complement
the process, the DMEPA uses a computerized method of identifying phonetic and
orthographic similarity between medication names. The program, Phonetic and
Orthographic Computer 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, DMEPA reviews the USAN stem list to determine if
any USAN stems are present within the proprietary name. The individual findings of
multiple safety evaluators are pooled and presented to the CDER Expert Panel. DMEPA
also evaluates if there are characteristics included in the composition that may render the
name unacceptable from a safety perspective (abbreviation, dosing interval, etc.).
2. Expert Panel Discussion
DMEPA gathers gather CDER professional opinions on the safety of the proposed
product and discussed the proposed proprietary name (Expert Panel Discussion). The
Expert Panel is composed of Division of Medication Errors Prevention (DMEPA) staff
and representatives from the Office of Prescription Drug Promotion (OPDP). We also
consider input from other review disciplines (OND, ONDQA/OBP). The Expert Panel
also discusses potential concerns regarding drug marketing and promotion related to the
proposed names.
The primary Safety Evaluator presents the pooled results of the database and information
searches to the Expert Panel for consideration. Based on the clinical and professional
experiences of the Expert Panel members, the Panel may recommend additional names,
additional searches by the primary Safety Evaluator to supplement the pooled results, or
general advice to consider when reviewing the proposed proprietary name.
3. FDA Prescription Simulation Studies
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

Reference ID: 3421195

10

 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.
4. 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.
5. Safety Evaluator Risk Assessment of the Proposed Proprietary Name
The primary Safety Evaluator applies his/her individual expertise gained from evaluating
medication errors reported to FDA, considers all aspects of the name that may be
misleading or confusing, conducts a Failure Mode and Effects Analysis, and provides an
overall decision on acceptability dependent on their risk assessment 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.3 When applying FMEA to assess the risk of
a proposed proprietary name, DMEPA seeks to evaluate the potential for a proposed
proprietary name to be confused with another drug name because of name confusion and,
thereby, 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 orthographically or phonetically similar drug names prior to approval, where actions to
overcome these issues are easier and more effective than remedies available in the postapproval phase.
In order to perform an FMEA of the proposed name, the primary Safety Evaluator must
analyze the use of the product at all points in the medication use system. Because the
proposed product is has not been marketed, the primary Safety Evaluator anticipates the
use of the product in the usual practice settings by considering the clinical and product

3

Institute for Healthcare Improvement (IHI). Failure Mode and Effects Analysis. Boston. IHI:2004.

Reference ID: 3421195

11

 characteristics listed in Section 1.2 of this review. 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
Discussion, and prescription studies, external studies, and identifies potential failure
modes by asking:
“Is the proposed proprietary name convincingly similar to another drug name,
which may cause practitioners to become confused at any point in the usual
practice setting? And are there any components of the name that may function
as a source of error beyond sound/look-alike?”
An affirmative answer indicates a failure mode and represents a potential for the
proposed proprietary name to be confused with another proprietary or established drug
name because of look- or sound-alike similarity or because of some other component of
the name. If the answer to the question is no, the Safety Evaluator is not convinced that
the names posses similarity that would cause confusion at any point in the medication use
system, thus the name is eliminated from further review.
In the second stage of the Risk Assessment, the primary Safety Evaluator evaluates all
potential failure modes to determine the likely effect 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 not ultimately be a source of medication errors in the
usual practice setting, the primary Safety Evaluator eliminates the name 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 the use of an alternate proprietary name.
Moreover, DMEPA will object to the use of proposed proprietary name when the primary
Safety Evaluator identifies one or more of the following conditions in the Overall Risk
Assessment:
a. OPDP finds the proposed proprietary name misleading from a promotional
perspective, and the Review Division concurs with OPDP’s findings. The Federal
Food, Drug, and Cosmetic Act provides that labeling or advertising can misbrand a
product if misleading representations are made or suggested by statement, word,
design, device, or any combination thereof, whether through a PROPRIETARY
name or otherwise [21 U.S.C 321(n); See also 21 U.S.C. 352(a) & (n)].
b. DMEPA identifies that the proposed proprietary name is misleading because of
similarity in spelling or pronunciation to another proprietary or established name of a
different drug or ingredient [CFR 201.10.(C)(5)].

Reference ID: 3421195

12

 c. FMEA identifies the potential for confusion between the proposed proprietary name
and other proprietary or established drug name(s), and demonstrates that medication
errors are likely to result from the drug name confusion under the conditions of usual
clinical practice.
d. The proposed proprietary name contains an USAN (United States Adopted Names)
stem.
e. DMEPA identifies a potential source of medication error within the proposed
proprietary name. For example, the proprietary name may be misleading or,
inadvertently, introduce ambiguity and confusion that leads to errors. Such errors
may not necessarily involve confusion between the proposed drug and another drug
product but involve a naming characteristic that when incorporated into a proprietary
name, may be confusing, misleading, cause or contribute to medication errors.
If DMEPA objects to a proposed proprietary name on the basis that drug name confusion
could lead to medication errors, the primary Safety Evaluator uses the FMEA process to
identify strategies to reduce the risk of medication errors. DMEPA generally
recommends that the Sponsor select an alternative proprietary name and submit the
alternate name to the Agency for review. However, in rare instances FMEA may identify
plausible strategies that could reduce the risk of medication error of the currently
proposed name. In that instance, DMEPA may be able to provide the Sponsor with
recommendations that reduce or eliminate the potential for error and, thereby, would
render the proposed name acceptable.
In the event that DMEPA objects to the use of the proposed proprietary name, based upon
the potential for confusion with another proposed (but not yet approved) proprietary
name, DMEPA will provide a contingency objection based on the date of approval.
Whichever product, the Agency approves first has the right to use the proprietary name,
while DMEPA will recommend that the second product to reach approval seek an
alternative name.
The threshold set for objection to the proposed proprietary name may seem low to the
Applicant/Sponsor. However, the safety concerns set forth in criteria a through e above
are supported either by FDA regulation or by external healthcare authorities, including
the Institute of Medicine (IOM), World Health Organization (WHO), the Joint
Commission, and the Institute for Safe Medication Practices (ISMP). These
organizations have examined medication errors resulting from look- or sound-alike drug
names, confusing, or misleading names and called for regulatory authorities to address
the issue prior to approval. Additionally, DMEPA contends that the threshold set for the
Proprietary Name Risk Assessment is reasonable because proprietary drug name
confusion is a predictable and preventable source of medication error that, in many
instances, the Agency and/or Sponsor can identify and rectify prior to approval to avoid
patient harm.
Furthermore, post-marketing experience has demonstrated that medication errors
resulting from drug name confusion are notoriously difficult to rectify post-approval.
Educational and other post-approval efforts are low-leverage strategies that have had
limited effectiveness at alleviating medication errors involving drug name confusion.
Sponsors have undertaken higher-leverage strategies, such as drug name changes, in the

Reference ID: 3421195

13

 past but at great ?nancial cost to the Sponsor and at the expense of the public welfare, not
to mention the Agency?s credibility as the authority responsible for approving the error-
prone proprietary name. Moreover, even after Sponsors? have changed a product?s
proprietary name in the post-approval phase, it is dif?cult to eradicate the original
proprietary name from practitioners? vocabulary, and as a result, the Agency has
continued to receive reports of diug name confusion long after a name change in some
instances. Therefore, DMEPA believes that post-approval efforts at reducing name
confusion errors should be reserved for those cases in which the potential for name
confusion could not be predicted prior to approval.

Appendix B: Letters and Letter Strings with Possible Orthographic or Phonetic

 

 

 

 

 

Misinterpr?etation
Letters in Name, Scripted May Appear as Spoken May Be Interpreted as
Akynzeo
Capital Ceany vowel
lower case ceany vowel
lower case 11. la. ck. c. ch
lower case g. p. 11. V. x. 2. any vowel

 

lower case 

11. 111. r. 11.x. a

gn. kn. l. 111, nm

 

 

 

 

 

 

 

 

 

 

 

 

 

Reference ID: 3421195

lower case c. g. 11. 111lower case a. c. i. o. 1 any vowel
lower case a. u. v.e any vowel
Letter Strings
Ak SleAnpendix C: Prescription Simulation Samples and Results
Figure l. Akmzeo Study (Conducted on October 18: 2013)

 

Handwritten Requisition Medication Order Verbal Prescription

 

Medication Order:

9! -

.1276)?. J) 

 

 

 

 

 

 

P2X :1 Akynzeo

Use as directed

 

Ou atient Prescri tion:

1/413
at 

 

Dispense: #1

 

 

 

 

 

Reference ID: 3421195 15

FDA Prescription Simulation Responses (Aggregate 1 Rx Studies Report)

192 People Received Study
59 People Responded

Study Name: Akynzeo

 

Total 2 6 22
INTERPRETATION OITTPATIENT VOICE INPATIENT TOTAL
AC KENZIO 0 1 0 1
AKENZIO 0 1 0 
AKEPAZEO 0 2 2
AKEPZEO 0 0 9 9
AKEPZEO 300 MG 0 0 1 1
AKEYNZEO 0 0 1 1
AKINSEO 0 1 1
AKIN $10 0 2 0 2
AKIN ZEO 0 3 0 3
AKINZIO 0 6 0 6
AKIPZEO 0 0 2 2
AKYAZEO 0 1 
AKYMYEO 1 0 0 1
AKYNYEO 2 0 2
AKYNZEO 1 8 0 5 2 3
AKYNZES 0 1 
OCHENSIO 1 0 1
OKINZIO 0 1 0 

 

 

 

Reference ID: 3421195 16

Appendix D: Proprietary names not likely to be confused or not used in usual practice
settings for the reasons described.

 

 

 

 

 

 

 

Proprietary Active Ingredient Similarity to Failure preventions
No. Cerdelga
ame
1 Kynamro Mipomersen sodilun Orthographic This name pair has suf?cient
orthographic differences.

 

Reference ID: 3421195

17

 

Appendix E: Risk of medication errors due to product confusion minimized by
dissimilarity of the names and/ or use in clinical practice for the reasons described.

 

Axiron
(Testosterone)
Transdermal Solution:
1- 30 mg/actuation
Usual Dose:

 

 

axrlla.

60 mg applied once daily to the

 


The letter string ?Ax? may appear

similar to the letter string ?Ak? in
Akynzeo when scripted.

Strength: Both are single strength
products

 

Orthomphic:

The name Akynzeo contains an
additional upstroke and a
that is absent in
the name Axiron giving the
names di??erent shapes.

Dose:

A 1 vs. onec sule

 

Astringyn

(Ferric subsulfate)
Topical solution:
3. 259 mg/g

Usual Dose:
Apply to wound.

 

 

 

Orthoggphic:
The letter string ?Astr? may

appear similar to the letter string
?Ak? in Akynzeo when scripted.

Strength: Both are single strength
products

 

Orthoggphic:

The name Astringyn yields a
di??erent shape since the
and are in
different positions in the name
Akynzeo with the 
occurring in the pre?x and
the occurring in
the sumx.

 

Reference ID: 3421 195

18

 

 

--------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------LISA V KHOSLA
12/12/2013
LUBNA A MERCHANT
12/12/2013

Reference ID: 3421195