CENTER FOR DRUG EVALUATION AND
RESEARCH
APPLICATION NUMBER:

205641Orig1s000
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 1, 2013

Reviewer:

Lissa C. Owens, PharmD
Division of Medication Error Prevention and Analysis

Team Leader:

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

Drug Name and Strength(s):

Asmanex HFA (Mometasone Furoate) Inhalation Aerosol
100 mcg and 200 mcg

Application Type/Number:

NDA 205641

Applicant/Sponsor:

Merck & Co. Inc.

OSE RCM #:

2013-2095

*** This document contains proprietary and confidential information that should not be released
to the public.***

Reference ID: 3415176

 CONTENTS
1

INTRODUCTION................................................................................................................... 1
1.1
Product Information......................................................................................................... 1
2 RESULTS................................................................................................................................ 1
2.1
Promotional Assessment ................................................................................................. 1
2.2
Safety Assessment ........................................................................................................... 1
3 CONCLUSIONS ..................................................................................................................... 4
3.1
Comments to the Applicant ............................................................................................. 4
4 REFERENCES ........................................................................................................................ 5
APPENDICES................................................................................................................................. 8

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 1

INTRODUCTION

This review evaluates the proposed proprietary name, Asmanex HFA, 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

PRODUCT INFORMATION

The following product information is provided in the September 12, 2013 proprietary
name submission.

2



Active Ingredient: Mometasone Furoate



Indication of Use: Maintenance treatment of Asthma as prophylactic therapy in
patients 12 and older



Route of Administration: Oral inhalation



Dosage Form: Inhalation Aerosol



Strength: 100 mcg and 200 mcg



Dose and Frequency: 2 inhalations twice daily



How Supplied: Pressurized aluminum canister with a blue plastic actuator
integrated with a dose counter



Storage:68°F to 77°F (20°C to 25°C); excursions permitted from 59°F to 86°F
(15°C to 30°C)

RESULTS

The following sections provide 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 Pulmonary
Allergy and Rheumatology Products concurred with the findings of OPDP’s promotional
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

The September 26, 2013 search of the United States Adopted Name (USAN) stems did
not identify that a USAN stem is present in the proposed proprietary name.

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 2.2.2

Components of the Proposed Proprietary Name

The Applicant indicated in their submission that the proposed name, Asmanex HFA, is a
coined term with no intrinsic meaning. They state that the intended meaning of the
“HFA” modifier Hydrofluoralkane and HFA is the accepted suffix used to designate they
hydrofluoralkane propellant in other respiratory products.
The proposed name Asmanex HFA is comprised of the root name, Asmanex, and the
modifier, HFA. The root name is currently marketed in the form of a dry powder inhaler,
‘Asmanex Twisthaler’. Asmanex HFA will be a metered dose inhaler. The naming
convention to use the modifier ‘HFA’ to represent the hydrofluroalkane and to
differentiate between the dry powder inhaler has been used before (e.g Advair Diskus and
Advair HFA and Flovent Diskus and Flovent HFA). Therefore, we do not find the
modifier, HFA, misleading or vulnerable to confusion and find it acceptable for this
product.
We note that modifiers may sometimes be omitted. However, the other dosage form in
this product line also utilizes a modifier. Thus a modifier would need to be specified or
obtained (if omitted on the order) to dispense the product. Therefore, we find the naming
convention, Asmanex HFA acceptable for this product.
2.2.3

Medication Error Data Selection of Cases

DMEPA searched FAERS database for medication errors involving Asmanex which
would be relevant for this review.
The September 18, 2013 search of the FDA Adverse Event Reporting System (FAERS)
database used the following search terms: Product Quality Issues (HLT), Product
Packaging Issues (HLT), Product Label Issues (HLT), and Medication Errors (HLGT).
After individual review, there were no reports involving name confusion and therefore no
reports included in the final analysis. The remaining cases will be evaluated in the label
and labeling review.
2.2.4

FDA Name Simulation Studies

Sixty-three 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. Thirty-four (outpatient study; n=16, inpatient study; n=12, voice
study; n=6) participants interpreted the name correctly as Asmanex HFA, seven (voice
study; n=7) participants interpreted the name as Asthmanex, two (inpatient study; n=2)
participants interpreted the name as Asmanex, two (inpatient study; n=2) participants
interpreted the name as Asmanex HFU, and two (outpatient study; n=2) participants
interpreted the name as Asmonex HFA. We have considered these variations in our lookalike and sound-alike searches and analysis (see Appendix B). See Appendix C for the
complete listing of interpretations from the verbal and written prescription studies.

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 2.2.5 Comments from Other Review Disciplines at Initial Review

In response to the OSE, September 30, 2013 e?mail, the Division of Division of
Puhnonary Allergy and Rhemnatology Products (DPARP) stated, ?The name ?Asmanex
HFA is reasonable from my perspective for a number of reasons 

1. Using ?Asmanex is reasonable, since changing the trade name of an established
inhaled moiety used in asthma management, thereby giving mometasonefuroate
for inhalation to treat asthma two di?erent names, would be confusing

2. It distinguishes between this new product and the approved ?Asmanex
wisthaler, which is the dry powder version of mometasone furoate from the
same Sponsor

3. There is precedent using the HFA to distinguish products for asthma based on
their device, for example, ?Advair Dis/ms [dry powder] and ?Advair HFA 


They further stated, ?in the past, the pulmonarv Division only used the as part of
the proprietary name if there had been a CFC version of the product, which is not the
case here. But I 'm not sure if there is going to be a second trademark equivalent to
"Twisthaler" as with 06 7, so perhaps the will help distinguish this product
from the Asmanex wisthaler. 

2.2. 6 Failure Mode and Effects Analysis of Similar Names

Appendix lists possible orthographic and phonetic misinterpretations of the letters
appearing in the proposed proprietary name, Asmanex HFA. Table 1 lists the names with
orthographic, phonetic, or spelling similarity to the proposed proprietary name, Asmanex
identi?ed by the primary reviewer, the Expert Panel Discussion (EPD), and other
review disciplines.

Table l: Collective List of Potentially Similar Names (DMEPA, EPD, Other Disciplines, and External Name

Study)
Look Similar

Name Source Name Source Name Source
esamet FDA enunenex FDA Arimidex FDA
AsmalPred Plus FDA Mucinex DM FDA Actinex FDA
Yasmin FDA HFA FDA

Look and Sound Similar

Name Source Name Source Name Source
Asmanex FDA Asmanex I-EFA FDA (4) FDA
Asmalix FDA Asmanex FDA (4) FDA

Twisthaler

Asmanex Twist FDA

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Our analysis of the 15 names contained in Table 1 determined none of the names will
pose a risk for confusion as described in Appendices D through E
2.2.7

Communication of DMEPA’s Analysis at Midpoint of Review

DMEPA communicated our findings to the Division of Pulmonary Allergy and
Rheumatology Products via e-mail on November 25, 2013. At that time we also
requested additional information or concerns that could inform our review. Per e-mail
correspondence from the Division of Pulmonary Allergy and Rheumatology Products on
November 27, 2013, they stated no additional concerns with the proposed proprietary
name, Asmanex HFA.
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 Nichelle Rashid, OSE
project manager, at 301-796-3904.
3.1

COMMENTS TO THE APPLICANT

We have completed our review of the proposed proprietary name, Asmanex HFA, and
have concluded that this name is acceptable.
If any of the proposed product characteristics as stated in your September 12, 2013
submission are altered, the name must be resubmitted for review.

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 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,

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

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.

10. 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.
11. 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.
12. Red Book (www.thomsonhc.com/home/dispatch)
Red Book contains prices and product information for prescription, over-the-counter
drugs, medical devices, and accessories.
13. Lexi-Comp (www.lexi.com)
Lexi-Comp is a web-based searchable version of the Drug Information Handbook.
14. Medical Abbreviations (www.medilexicon.com)
Medical Abbreviations dictionary contains commonly used medical abbreviations and
their definitions.
15. CVS/Pharmacy (www.CVS.com)
This database contains commonly used over the counter products not usually
identified in other databases.
16. Walgreens (www.walgreens.com)
This database contains commonly used over the counter products not usually
identified in other databases.
17. Rx List (www.rxlist.com)
RxList is an online medical resource dedicated to offering detailed and current
pharmaceutical information on brand and generic drugs.

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 18. 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.
19. Natural Standard (http://www.naturalstandard.com)
Natural Standard is a resource that aggregates and synthesizes data on complementary
and alternative medicine.

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 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.

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 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.

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 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

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 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

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 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.

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 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)].

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 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: 3415176

14

 past but at great financial 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 errorprone proprietary name. Moreover, even after Sponsors’ have changed a product’s
proprietary name in the post-approval phase, it is difficult to eradicate the original
proprietary name from practitioners’ vocabulary, and as a result, the Agency has
continued to receive reports of drug 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.

Reference ID: 3415176

15

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

 

 

 

 

 

 

 

 

 

 

 

 

 

Misintelpretation

Letters in Name, Scripted May Appear as Spoken May Be

Asmanex HFA Interpreted as
Upper case ce. FL. H. 5 Any Vowel
Lower case Any Vowel
Lower case Lower case 111. m1. 11. v. w. wi. vi. onc. 2
Lower case m. u. x. r. 11. dn. gn. kn. 11m. pn. n1
Lower case a. i. 1. o. u. Any Vowel
Lower case Upper case Fl
Lower case ?11? k. b. n. 
Upper case T. PF. P11
Lower case ?f 

Letter Strings

 

 

 

 

 

 

 

Appendix C: Prescription Simulation Samples and Results

Figure l. Asmanex HFA Studv (Conducted on September 20: 2013)

 

Handwritten Requisition Medication Order

Verbal Prescription

 

Medication Order:

Mm 
WW ?Mg?

Outpatient Prescription:

WW Q;p {755-4 00m 


 

 

 

 

 

 

 

 

 

Reference ID: 3415176 16

 

FDA Prescri tion Simulation Res 0 onses A re ate 1 Rx Studies Re ort
INTERPRETATION OI7TPATIENT VOICE INPATIENT TOTAL
ASMANEX 0
ASMANEX FDA 0
ASMANEX HFA 16
ASMANEX HFDA
ASMANEX HFU
ASMANEX HGA
ASMANEX HSA
ASMANEX NHA
ASMENEX HFA
ASMENIX HF A
ASMINEX ASA
ASMONEX HFA
ASNANEX HFA
ASONEX 
ASTHMANAX HFA
ASTHMANEX HFA

ASTHMANEX
HSA 1 OOMC 

ASTHIVIONEX HFA
ASWAN EX HFA
AZMANEX HSA
AZMINEX HFA

 






r?er?va?tr?nv?Iv??u?amr?e

p?n


p?l








v?I

 

 

OOHO


D?lt??D??P?l

 

Reference ID: 3415176 17

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reference ID: 3415176

 

 

 

 

Proprietary Active Ingredient Similarity Failure preventions
to
No. Name
Asmanex
HFA
HFA None Look and HFA (Hydro?uoroalkane) represents the
1. Sound type of propellant. It is not available
independently.
2 Asmanex HFA Mometasone Furoate Look and This name is the subject of this review
Sound
Asmanex Twist Unknown Look and Name formd on Redbook. however. no
3 Sound infonnation is available in drug
references. The name has not been submitted
to the Agency.
Asmanex Mometasone Furoate Look and This name is similar to the root name
4 Sormd ?Asmanex? which is currently marketed. We
did not identify any wrong drug errors in our
search.
esamet Nabilone Look This name is similar to the root name
5 ?Asmanex? which is currently marketed. We
did not identify any wrong drug errors in our
search.
erumenex Triethanolamine Polypeptide Look This name is similar to the root name
Oleate ?Asmanex? which is crurently marketednot identify any wrong drug errors in our
search.
Arimidex Anastrozole Look This name is similar to the root name
7 ?Asmanex? which is cru?rently marketed. We
did not identify any wrong drug errors in our
search.
Actinex Masoprocol Look This name is similar to the root name
8 ?Asmanex? which is currently marketed. We
did not identify any wrong drug errors in our
search.
Yasmin Drospirenone and Ethinyl Look This name is similar to the root name
9 Estradiol ?Asmanex? which is crurently marketed. We
did not identify any wrong drug errors in our
search.
(0) (4
O.
Asmalix Look and This name is similar to the root name
Sound ?Asmanex? which is currently marketeddid not identify any wrong drug errors in our
search.
(4)
2 .
8

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.

 

 

 

 

 

No. Proposed name: Failure Mode: Prevention of Failure Mode
Asamauex HFA Incorrect Product
(Mometasone Ordered/
Furoate) Selected/Dispensed In the conditions outlined below, the following
or Administered combination of factors, are expected to minimize the
Dosage Form(s): . .
. because of Name risk of confusron between these two names
Inhalation Aerosol .
confusrou
Strength. 100 Causes (could be
and 200 .
multiple)
Usual Dose: Two
inhalations twice
daily
Asmanex Twisthaler Orthographic: The pair Orthographic: When comparing the modi?ers. vs.
(Mometasone Furoate). have the same root ?Twisthaler'. look differently when scripted and have different
110 and 220 mg name. ?Asmanex? shapes. HFA (3 letters) is shorter when scripted than Twisthaler
Usual Dose: 1 to 2 Freguency: Both may be (9 letters).

1. inhalations once to twice daily Strength: 100 me and 200 vs. 110 and 220 

twrce daily Dose: Both may be two If the modi?ers are dropped and the different are

inhalations overlooked and a patient receives the wrong inhaler and uses it.

they will get the same drug. There are no clinical implications if
the inhalers are confused

Mucinex DM Orthogaphic: When Orthogaphic: When compared to the root name. the begiiming

(Guaifenesin and compared to the root letter strings. ?Asm? vs. ?Muc? appear different when scripted.

Dextromethorphan) name. the pair have the When compared to the modi?er. vs. appear

Extended-release same ending letter different when scripted.

2' Tablets. 600 mg/30 mg strings. nex Strength: Multiple that would need to be indicated on
Usual Dose: 1 to 2 Frequency: Both are the medication order or prescriptions. There are no overlaps or
tablets every 12 hours. twice daily munerical similarity vs. Single strength

Qose: Two inhalations vs. XX tablets

AsmalPred Plus Orthogaphic: When Orthogaphic: When compared to the root name. the ending letter
(Prednisolone Soditun compared to the root strings. ?anex? vs. ?Pred? appear different when scripted.
Phosphate) Oral name. the pair have the AsmalPred contains additional upstroke letters and the letter
Solution. 15 mg/SmL same begirming letter that may be scripted as an upstroke of a 

. . string. ?Asma? Asmanex does not contain the letters giving the pair different
Discontinued but . 

. . shapes. When compared to the modi?er. HFA vs. Plus the
generics available . . .
3' pair appear different when 

 

Usual Dose: 1.three to four divided
doses.

 

 

Frequency: Twice daily vs. up to three to four times daily

Strength: Multiple that would need to be indicated on
the medication order or prescriptions. There are no overlaps or
munerical similarity vs. Single strength

Dose: Two inhalations vs. XX mL or XX teaspoonful

 

Reference ID: 3415176

19

 

--------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------LISSA C OWENS
12/01/2013
LUBNA A MERCHANT
12/01/2013

Reference ID: 3415176