Contents of a Complete 
Submission for the 
Evaluation of 
Proprietary Names 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
 
April 2016 
Labeling 
 
Revision 1 
   
 
 
Contents of a Complete 
Submission for the 
Evaluation of Proprietary 
Names 
Guidance for Industry 
 
Additional copies are available from: 
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Center for Drug Evaluation and Research 
Food and Drug Administration 
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http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm    
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Drug Evaluation and Research (CBER) 
  
April 2016 
Labeling 
 
Revision 1 
  Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
A.  Recommendations to Minimize Medication Errors .................................................................... 2 
B.  Medication-Use Systems ................................................................................................................ 4 
C.  Proprietary Name Confusion and Medication Errors ................................................................ 4 
D.  FDAs Approach to the Evaluation of Proposed Proprietary Names ....................................... 5 
E.  Regulatory Authority..................................................................................................................... 7 
III.  PDUFA IV GOAL DATES .............................................................................................. 8 
IV.  CONTENTS OF A COMPLETE SUBMISSION FOR EVALUATION OF   
PROPOSED PROPRIETARY NAMES ......................................................................... 9 
A.   General Information ...................................................................................................................... 9 
B.  Proposed Proprietary Name ....................................................................................................... 10 
C.  Additional Information about the Product ................................................................................ 11 
D.  Information about Product Dispensing and Delivery ............................................................... 14 
E.  Independent Assessments of Proprietary Name, Packaging, and/or Labeling ...................... 15 
V.  WHEN AND WHERE TO SEND A SUBMISSION FOR A PROPOSED 
PROPRIETARY NAME REVIEW .............................................................................. 15 
A.  Drug Products, Including Biologics, That Are the Subject of an IND, NDA, or BLA  
Paper Submission ......................................................................................................................... 15 
B.  Drugs Products That Are the Subject of an ANDA  Paper Submission ............................. 16 
C.  Electronic Submissions ................................................................................................................ 16 
GLOSSARY................................................................................................................................. 18 
  i  Contains Nonbinding Recommendations 
 
1
Guidance for Industry  
Contents of a Complete Submission for the Evaluation of 
Proprietary Names 
 
 
This guidance represents the Food and Drug Administrations (FDAs) current thinking on this topic.  It 
does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes 
and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for 
implementing this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate 
number listed on the title page of this guidance.  
 
 
 
I.  INTRODUCTION  
 
This guidance describes for industry the information that FDA uses to evaluate proposed 
proprietary names for certain drugs, including biological products, under the traditional review 
process within the time frames set out in Prescription Drug User Fee Act (PDUFA IV) 
performance goals.  The review clock for the performance review goals begins when the Agency 
receives a complete submission2 (see sections II. Background and III. PDUFA IV Goal Dates).   
Accurate identification of medications is critical to preventing medication errors and potential 
harm to the public.  This guidance is intended to assist industry in the submission of a complete 
package of information that FDA will use in the assessment of:  
1.  the safety aspects of a proposed proprietary name, to reduce medication errors, and  
2.  the promotional implications of a proposed proprietary name, to ensure compliance 
with other requirements for labeling and promotion using our traditional review methods.   
This guidance applies to proprietary name submissions for the following types of products: 
  prescription drug products, including biologics, that are the subject of an investigational 
new drug application (IND), a new drug application (NDA), an abbreviated new drug 
application (ANDA), or a biologics license application (BLA) 
  nonprescription drug products that are the subject of an IND, NDA, or ANDA 
 
This guidance does not describe the methods used for evaluation of proposed proprietary names 
using the traditional review process, nor does the guidance describe the information needed by 
FDA to evaluate proposed proprietary names under the voluntary 2-year pilot program being 
                                                 
1 This guidance has been prepared by the Division of Medication Error Prevention and Analysis, Office of 
Surveillance and Epidemiology, in the Center for Drug Evaluation and Research (CDER) in cooperation with the 
Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration.  
 
2 All terms presented in bold italics at first use in this guidance are defined in the Glossary. 
 
  1  Contains Nonbinding Recommendations 
 
conducted by CDER and CBER.  That information can be found in the FDA concept paper 
entitled PDUFA Pilot Project Proprietary Name Review, dated September 2008.3   
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required.  
 
 
II.  BACKGROUND 
 
On September 27, 2007, the reauthorization and expansion of the Prescription Drug User Fee Act 
(PDUFA IV) was signed into law as part of Public Law 110-85, 121 Stat. 823. The 
reauthorization of PDUFA significantly broadens and strengthens the Food and Drug 
Administrations (FDA) drug safety program, facilitating more efficient development of safe and 
effective new medications for the American public.  As part of the reauthorization of PDUFA, 
FDA committed to certain performance goals in its goals letter.4  In that letter, FDA stated that it 
would use user fees to implement various measures to reduce medication errors related to look-
alike and sound-alike proprietary names, unclear label abbreviations, acronyms, dose 
designations, and error-prone label and packaging designs. 
   
Among these measures, FDA agreed to publish guidance on the contents of a complete 
submission package for a proposed proprietary name for a drug or biological product.  FDA also 
agreed to performance goals for review of proprietary names submitted during the IND phase or 
with an NDA or BLA; the goals stipulate that a complete submission is required to begin the 
review clock.  
 
A.  Recommendations to Minimize Medication Errors 
 
This guidance and other PDUFA IV proprietary name evaluation measures grow out of 
initiatives aimed at minimizing medication errors. 
 
In 2000, the Institute of Medicine (IOM) published a report entitled To Err Is Human:  Building 
a Safer Health System.5 The report stated that from 44,000 to 98,000 deaths occur yearly due to 
                                                 
3 The concept paper describes the comprehensive evaluation that applicants should submit to FDA for a proposed 
proprietary name review under the pilot program, including the information and data listed in Appendix B of the 
concept paper (Proposed Template for a Pilot Program Submission).  The concept paper is available on the 
Internet at 
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072229.pdf,   
     
4 See the letter from the Secretary of Health and Human Services to the Chairman of the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the 
House of Representatives, as set forth in the Congressional Record (goals letter), at  
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm. 
 
5 Kohn LT, Corrigan JM, Donaldson MS, eds. To Err Is Human:  Building a Safer Health System. Institute of 
Medicine, National Academies Press: Washington DC. 2000. 
  2  Contains Nonbinding Recommendations 
 
medical errors, making medical errors the eighth leading cause of death in the United States. 6  
The report identified medication errors as the most common type of error in health care.  Seven 
thousand (7,000) deaths annually were attributed to medication errors.7  The IOM recommended 
that FDA  
  develop and enforce standards for the design of drug packaging and labeling that 
will maximize safety in use and  
  require pharmaceutical companies to test proposed drug names to identify and 
remedy potential sound-alike and look-alike confusion with existing drug names.8  
 
In July 2006, the IOM published a report entitled Preventing Medication Errors. In this report, 
the IOM cited labeling and packaging issues as the cause of 33 percent of medication errors, 
including 30 percent of fatalities from medication errors.9  Given the critical role of the label and 
labeling in the safe use of drug products, this statistic is not surprising.  The container label, 
carton, and (for prescription drug products) professional insert labeling are the primary means by 
which practitioners and patients identify and make decisions about using the product.  Carton 
and container labels communicate critical information including proprietary and established 
name, strength, dosage form, container quantity, and expiration date, and are particularly critical 
for nonprescription (over-the-counter (OTC)) drug products.  For prescription products, the 
professional insert labeling is intended to communicate to practitioners all information relevant 
to the approved uses of the product, including the correct dosing and administration.  
 
The July 2006 IOM report stated that Product naming, labeling, and packaging should be 
designed for the end user  the provider in the clinical environment and/or the consumer.10 
The report also urged FDA to incorporate better principles of cognitive and human factors 
engineering to address issues concerning information presentation in labeling and 
nomenclature.11   
 
                                                                                                                                                             
 
6 American Hospital Association.  Hospital Statistics. Chicago. 1999.  See also: Brennan TA, Leape LL, Laird NM., 
et al. Incidence of Adverse Events and Negligence in Hospitalized Patients:  Results of the Harvard Medical Practice 
Study I. N Engl J Med. 324:370-376, 1991; Leape LL, Brennan TA, Laird NM, et al.  The Nature of Adverse Events 
in Hospitalized Patients:  Results of the Harvard Medical Practice Study II. N Engl J Med. 324(6):377-384, 1991;  
Centers for Disease Control and Prevention (National Center for Health Statistics).  Births and Deaths:  Preliminary 
Data for 1998. National Vital Statistics Reports. 47(25):6, 1999, cited in To Err Is Human, p. 1.  
 
7 Phillips, DP, Christenfeld, N, and Glynn, LM. Increase in US Medication-Error Deaths between 1983 and 1993.  
The Lancet. 351:643-644, 1998, cited in To Err Is Human, p. 2. 
 
8 This effort is also consistent with FDA's May 10, 1999 report to the FDA Commissioner titled Managing the Risks 
From Medical Product Use, which underscored the importance of providing an adequate risk assessment associated 
with the use of drug products, including a mandate to reduce medication errors from proprietary name confusion.  
 
9 Aspden P, Wolcott JA, Bootman JL, Cronenwett LR, eds. Preventing Medication Errors.  Institute of Medicine, 
The National Academies Press:  Washington DC.  2006.  Chapter 6:  p. 275. 
 
10 IOM, Preventing Medication Errors.  Chapter 6, Recommendation 4, p. 280. 
 
11 IOM, Preventing Medication Errors.  Chapter 2, p. 61. 
 
  3  Contains Nonbinding Recommendations 
 
In addition to the IOM recommendations, the Secretary of Health and Human Services published 
a report titled Bringing Common Sense to Health Care Regulation: Report of the Secretarys 
Advisory Committee on Regulatory Reform (November 2002).  This report recommended that 
FDA adopt safe labeling practices for all FDA-regulated products to improve patient safety and 
decrease preventable adverse drug events.   
 
B.  Medication-Use Systems  
 
Medication use within a health care organization can be viewed as a system with several 
components and processes, including: 
  inputs (patient and drug therapy information),  
  throughputs (care provided), and  
  outputs (effective, efficient, and safe treatment).12   
 
Depending on the setting and organization, there are many variables interacting within a 
medication-use system.  These variables include, but are not limited to 
  different processes and procedures,  
  different types of health care providers involved,  
  different patients,  
  different products,  
  different storage and dispensing conditions, and  
  different available technologies.  
 
The many variables and interactions within the medication-use system create ample opportunity 
for confusion and medication errors.  
 
C.  Proprietary Name Confusion and Medication Errors 
 
In the U.S. medication-use system, health care providers rely on the proprietary name as the 
critical identifier of the appropriate therapy in a market of thousands of products; therefore, 
accurate interpretation of the product name is essential to ensure that the correct product is 
procured, prescribed, prepared, dispensed, and administered to the patient.  Products might be 
prone to error in use due to sound-alike or look-alike names, unclear labeling, or poorly designed 
packaging.13  Product names that look and/or sound alike can lead to medication error and 
potential harm to patients by increasing the risk that health care providers could misunderstand 
the product name, prescribe the wrong product, dispense and/or administer the wrong product, or 
dispense a product incorrectly.  Similarly, product names that look and/or sound alike may lead 
consumers to select or administer their nonprescription medication incorrectly. 
 
   
                                                 
12 Medication Use:  A Systems Approach to Reducing Errors. Joint Commission on Accreditation of Healthcare 
Organizations, 1998, p. 6.  
 
13 IOM, To Err Is Human, p. 136. 
 
  4  Contains Nonbinding Recommendations 
 
D.  FDAs Approach to the Evaluation of Proposed Proprietary Names 
 
As part of its premarket review of products that are the subject of an NDA, BLA, or ANDA, 
FDA evaluates both safety and promotional aspects of the products proposed proprietary 
name.14 For tools and methods FDA uses for its analysis, see the FDA concept paper entitled 
PDUFA Pilot Project Proprietary Name Review (concept paper).15   
 
1.  Safety Evaluation 
 
FDAs safety review of a proposed proprietary name focuses on the prevention of medication 
errors.  Accurate identification of medications is critical to preventing medication errors and 
potential harm to the public.  Because medication errors due to product misidentification or 
confusion can occur at any point in the medication-use system, in its evaluation of a proposed 
proprietary name, FDA considers the potential for confusion throughout the entire U.S. 
medication-use system, including product procurement, prescribing and ordering, dispensing, 
administration, and monitoring the effects of the medication.16    
 
FDAs safety review of a proposed proprietary name involves multiple methods to identify 
potentially problematic proprietary names, including the following: 
  a preliminary screening to identify common errors  
  a USAN17 stem search  
  an orthographic/phonological similarity assessment  
  drug database searches, computational methods, and/or prescriptions simulation studies 
to test the likelihood of confusion between the proposed proprietary name and similar 
names  
 
The failure modes and effects analysis (FMEA)18 is one of the tools used in the medication error 
safety assessment of the proposed proprietary name.  After identifying potential look-
alike/sound-alike names, a FMEA of these names is performed to determine where failures might 
                                                 
14 Legal authorities are explained in the next section.  
 
15 The tools and methods for FDAs safety review of a proposed proprietary name are outlined in section IV.A of the 
concept paper, available on the Internet at  
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072229.pdf.  
 
16 IOM, Preventing Medication Errors.   
 
17 The stem list is created by the United States Adopted Names (USAN) Council. The purpose of the Council is to 
serve the health professions of the United States by selecting simple, informative, and unique nonproprietary names 
for drug products.  Selections are made by establishing logical nomenclature classifications based on 
pharmacological and/or chemical relationships.  For a list of all recognized USAN stems,  
see   
http://www.ama-assn.org/ama/pub/about-ama/our-people/coalitions-consortiums/united-states-adopted-
names-council/naming-guidelines/approved-stems.shtml 
18 FMEA is a systematic tool for evaluating a process and identifying where and how it might fail. Institute for 
Healthcare Improvement (IHI).  Failure Modes and Effects Analysis.  Boston. IHI:2004.  
 
  5  Contains Nonbinding Recommendations 
 
occur in the medication-use system with the proposed product.  In addition, a proposed 
proprietary name is evaluated for its potential to inadvertently function as a source of error for 
reasons that are unrelated to the orthographic and phonological similarity to other product names.  
These situations could occur, for example, when a proposed proprietary name for a multi-
ingredient product represents only one of the active ingredients contained in the product (see 21 
CFR 201.6(b)); when names suggest a frequency or route of administration inconsistent with the 
actual product characteristics; or when names look or sound like other medical terms or 
diagnostic tests or use a standard medical abbreviation in the name.  Names with these 
characteristics may be potentially misleading and cause confusion at any point under the 
proposed prescribing conditions and lead to medication errors.   
 
To fully assess the safety of proposed proprietary names, it is essential that product 
characteristics be considered in the overall risk assessment.  The proposed proprietary name and 
product characteristics provide the framework for how product variables will interact within the 
medication-use system and provide the context for the verbal and written communication of the 
drug name.  Product characteristics can act together with the orthographic and phonologic 
attributes of the proposed proprietary name (1) to increase the risk of confusion when there is an 
overlap in product characteristics among two or more products, or (2) in some instances, to 
decrease the risk of confusion by helping to differentiate products through dissimilarity.   
 
FDA considers typical product characteristics that could lead to confusion with other products, 
including, but not limited to, the following: 
  established name of the product  
  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  
  prescriber population  
 
FDA staff use the product characteristics in the analysis of a proprietary name to anticipate the 
clinical setting(s) in which the product is likely to be used.   
 
2.  Promotional Evaluation 
In addition to the safety review, FDA conducts a promotional review of proposed proprietary 
names.  This promotional review considers whether the name functions to overstate the efficacy, 
minimize the risk, broaden the indication, or make unsubstantiated superiority claims for the 
product, or is overly fanciful by misleadingly implying unique effectiveness or composition, or 
is otherwise false or misleading. (See 21 U.S.C 321(n), 352(a) and (n); see also 21 CFR 201.10 
(c)(3), 202.1(a)(3), (e)(5)(i), and (e)(6)(i).)  
  6  Contains Nonbinding Recommendations 
 
  
E.  Regulatory Authority 
 
FDAs authority to obtain submissions that address proprietary names and regulate proprietary 
names is based on the Federal Food, Drug, and Cosmetic Act (the Act) and Agency regulations.  
Among these authorities are the following: 
 
Proprietary names are used in a products labels and labeling, as well as in other promotional 
materials.  Under section 502(a) of the Act (21 U.S.C. 352(a)), a drug, including a biologic, is 
misbranded if its labeling is false or misleading in any particular.19  In addition, section 351(b) of 
the Public Health Service Act (42 U.S.C. 262(b)) prohibits falsely labeling or marking any 
package or container of any biological product.20  Under section 505(d)(7) of the Act (21 U.S.C. 
355(d)(7)), an NDA or ANDA shall not be approved if the drug's labeling is false or misleading 
in any particular.  See also 21 CFR 314.125(b)(6) and (b)(8) (grounds for refusal to approve an 
NDA or ANDA, including that proposed labeling is false or misleading in any particular or that 
labeling does not comply with requirements of 21 CFR part 201); 21 CFR 314.105(c) (requiring 
compliance with statutory standards for labeling in order to approve an NDA or ANDA); 21 
CFR 601.4(b) (BLA shall be denied if establishment or product does not meet  requirements 
specified in FDA regulations, including requirements of part 201).  NDAs, ANDAs, and BLAs 
must contain labeling and all other information about the drug that is pertinent to evaluation of 
the application, to provide FDA with a basis on which to make the required findings for approval 
or licensure. (See 21 CFR 314.50; 21 CFR 601.2.)  
 
Section 201(n) (21 U.S.C. 321(n)) indicates that when a drug is alleged to be misbranded 
because its labeling or advertising is misleading, the determination of whether the labeling or 
advertising is misleading should take into account (among other things): 
 
not only representations made or suggested by statement, word, design, device, or any 
combination thereof, but also the extent to which the labeling or advertising fails to 
reveal facts material in the light of such representations or material with respect to 
consequences which may result from the use of the article to which the labeling or 
advertising relates under the conditions of use prescribed in the labeling or advertising 
thereof or under such conditions of use as are customary or usual.  
 
In addition to this general principle, applicable to proprietary names, several FDA regulations 
specifically address ways in which the name of a drug may render its labeling misleading.  For 
example, FDA regulations at 21 CFR 201.6(b) state: 
 
The labeling of a drug which contains two or more ingredients may be misleading by 
reason, among other reasons, of the designation of such drug in such labeling by a name 
                                                 
19 See 42 U.S.C.  262(j) (Federal Food, Drug, and Cosmetic Act applies to products subject to biologics license 
under the Public Health Service Act, except that licensed products need not also have approval under section 505 of 
the Act).   
 
20 See also section 502(n) of the Act, 21 U.S.C. 352(n) (advertising of a prescription drug misbrands unless it 
contains a true statement of other information in brief summary relating to side effects, contraindications, and 
effectiveness); 21 CFR 202.1(e)(5)(addressing "true statement" requirement).; 21 CFR 202.1(k) (prescription drugs 
misbranded if not compliant with section 502(n) of the act and implementing regulations). 
 
  7  Contains Nonbinding Recommendations 
 
which includes or suggests the name of one or more but not all such ingredients, even 
though the names of such ingredients are stated elsewhere in the labeling. 
 
Likewise, 21 CFR 201.10(c)21 states that the labeling of a drug may be misleading by reason of: 
 
(3) The employment of a fanciful proprietary name for a drug or ingredient in such a 
manner as to imply that the drug or ingredient has some unique effectiveness or 
composition when, in fact, the drug or ingredient is a common substance, the limitations 
of which are readily recognized when the drug or ingredient is listed by its established 
name.  
. . . . 
 
(5) Designation of a drug or ingredient by a proprietary name that, because of similarity 
in spelling or pronunciation, may be confused with the proprietary name or the 
established name of a different drug or ingredient.   
 
Based on these authorities, applicants must submit, and FDA reviews, proposed proprietary 
names as part of NDAs, ANDAs, and BLAs.  To further their business goals, many drug 
manufacturers prefer to have FDA evaluate a proposed proprietary name even earlier in the drug 
development process, when possible.  Consequently, FDA permits manufacturers, if they wish, 
to seek FDAs initial evaluation of a proposed proprietary name prior to the submission of the 
marketing application, while the product remains under an IND.  However, to ensure that 
resources are not used to evaluate proposed proprietary names for products that will not be viable 
candidates for an NDA, ANDA, or BLA, or for which proposed indications are not yet 
sufficiently clear to form the basis of an evaluation of a name for potential medication errors, 
FDA does not evaluate proprietary names until products have completed phase 2 trials. 
  
 
III.  PDUFA IV GOAL DATES 
 
In accordance with the PDUFA IV goals, the review clock for a proposed proprietary name 
evaluation will not begin if a submission is not complete. FDA will notify the applicant or 
sponsor in writing if it considers a submission to be incomplete.   
 
If the proposed proprietary name submission is considered complete, the PDUFA IV review 
clock will be started using the date of receipt of the proposed proprietary name submission 
(i.e., FDA stamped date of receipt).  
 
To meet the review performance goals: 
 
  The review of a complete submission for a proposed proprietary name submitted during the 

IND phase must be completed and a tentative acceptance or non-acceptance about the name 
must be communicated to the sponsor within 180 days of the receipt of the complete 
submission.   
 
  The review of a complete submission for a proposed proprietary name submitted with an 

NDA or BLA or as part of a supplement must be completed and a tentative acceptance or 
                                                 
21 Compare  21 CFR 202.1(a)(3) and (a)(5) (similar provisions addressing use of proprietary names in advertising). 
  8  Contains Nonbinding Recommendations 
 
non-acceptance about the name must be communicated to the applicant within 90 days of the 
receipt of the complete submission.           
 
A new review clock using the same PDUFA IV review performance goal dates applies to the 
written request for the submission of alternate proposed proprietary names or reconsideration of 
the primary proposed proprietary name with supporting data (i.e., 180 days for an IND from 
receipt of complete submission and 90 days for an NDA or BLA from receipt of complete 
submission). 
 
For proposed proprietary names that are submitted under an ANDA, the PDUFA IV performance 
goals do not apply.   
 
 
IV.  CONTENTS OF A COMPLETE SUBMISSION FOR EVALUATION OF  
  PROPOSED PROPRIETARY NAMES   
 
This section describes the information FDA recommends that a sponsor or applicant include to 
ensure that the Agency can conduct a complete review of a proposed proprietary name using our 
traditional review methods.   
 
  A.   General Information 
 
Each submission should be identified as follows: 
 
  For proposed proprietary name reviews, include the statement REQUEST FOR 
PROPRIETARY NAME REVIEW in bold, capital letters on the first page of the 
submission. 
  For amendments to proposed proprietary name reviews, include the statement 
AMENDMENT TO REQUEST FOR PROPRIETARY NAME REVIEW in bold, 
capital letters on the first page of the submission.   
  For proposed proprietary names that applicants and sponsors are submitting for 
reconsideration following an initial rejection of their proposed proprietary names, include the 
statement REQUEST FOR RECONSIDERATION OF PROPRIETARY NAME in 
bold, capital letters on the first page of the submission.  
 
A proposed proprietary name evaluation submission for a drug product, including a biologic, that 
is the subject of an IND should include FDA Form 1571; a proposed proprietary name evaluation 
submission for a drug product, including a biologic, that is the subject of an NDA, ANDA, or 
BLA should include FDA Form 356h.  The forms should provide information including the 
following:  
  Proposed first choice proprietary name22  
  Application number (BLA/NDA/ANDA/IND) 
                                                 
22 On FDA Form 1571, we recommend that you provide the proposed proprietary name under item 11 by checking 
Other and providing the proposed proprietary name in the accompanying box. On FDA Form 356h, we 
recommend you include the proposed proprietary name under the section Application Description by providing 
the proposed proprietary name in the box labeled Reason for Submission. 
 
  9  Contains Nonbinding Recommendations 
 
  Applicant or sponsor contact information including the company name, name and title of 
the contact person, address, phone number, fax number, and e-mail address 
  Identification of the submission as a Request for Proprietary Name Review, Request for 
Reconsideration of Proprietary Name, or Amendment to a Request for Proprietary Name 
Review.23  
  A list of contents in the submission  
 
B.  Proposed Proprietary Name 
 
All submissions should include the following information about the proposed proprietary name. 
 
1.  Primary and Alternate Proposed Proprietary Name 
 
The applicant or sponsor can include up to two proposed proprietary names for review in a 
submission and should specify the first choice.  The alternate name will not be evaluated unless 
the primary name is found to be unacceptable and the applicant or sponsor has confirmed in 
writing to the appropriate center that it would like its alternate proposed proprietary name 
reviewed. Once a written confirmation is received, a new PDUFA IV clock will begin for review 
of the alternate proposed proprietary name.   
 
2.  Intended Pronunciation of the Proposed Proprietary Name   
   
FDA encourages the applicant or sponsor to provide a written transliteration of the intended 
pronunciation of the proposed proprietary name.  Although FDA evaluates the various 
pronunciations of a proposed name to reflect the variations that might be observed in clinical 
practice, consideration is given to the intended pronunciation of the name that the applicant or 
sponsor will promote, as this may influence pronunciation of the name in practice.    
 
3.  Derivation of Proprietary Name 
 
The submission should include an explanation of the derivation of the proposed proprietary 
name, if any.   
 
4.  Intended Meaning of Proprietary Name Modifiers (e.g., prefix, suffix) 
 
A modifier, such as a prefix or suffix, in the proprietary product name might suggest different 
meanings to health care professionals and consumers, which could potentially lead to product 
confusion. When an applicant or sponsor submits a product name with a modifier (for example, 
with the prefix Lo- or the suffix XR), the submission should include the intended meaning of the 
modifier, the rationale for the modifier, and any studies that have been conducted to support the 
use of the modifier. 
 
                                                 
23 On FDA Form 1571, we recommend that you include this information under item 11 by checking Other and 
providing the applicable description in the accompanying box. On FDA Form 356h, we recommend you include this 
information under the section Application Description by providing the applicable description in the box labeled 
Reason for Submission. 
  10  Contains Nonbinding Recommendations 
 
5.  Pharmacologic/Therapeutic Category  
 
The submission should include the pharmacologic/therapeutic category under which the product 
with the proposed proprietary name will be classified. 
 
C.  Additional Information about the Product 
 
This section describes what should be included in a submission when a product has a proposed 
label and labeling, and what should be included in a submission when a product does not yet 
have a proposed label and labeling.  
 
1.  Submission for a Product That Has Proposed Labels and Labeling  
 
a.  Proposed Labeling 
 
The submission should include the proposed labeling.  In the case of a prescription product, the 
professional labeling, also referred to as physician labeling or the package insert, provides 
important information for FDAs evaluation of proposed proprietary names and other factors in 
association with the name that can contribute to product confusion.  If a proposed patient 
package insert or proposed Medication Guide is available, it should also be included.  See 
section IV.C.2 of the guidance for a list of information that should be provided if the submission 
does not include the proposed labeling.   
  
b.  Proposed Container Labels and Labeling  
 
The submission should include the proposed container label and other proposed external labeling 
or packaging, such as carton labels, pouches or overwraps, and sample labels.  The submission 
should indicate the size of the actual label and provide the label, labeling, and packaging in color 
and reflect the presentation that will be used in the marketplace, so that FDA can assess the 
presentation of the product name and information.  For small container labels and labeling, 
please provide the original copy and a larger copy for ease of review.   
 
When two proprietary names are identified as having sound-alike or look-alike similarity, the 
risk of confusion between the product names may increase when the overall appearance of two 
products packaging is similar or when the products are stored in a similar or same environment.  
When coupled with some similarity in proprietary names, the packaging is an important product 
characteristic to consider in the overall name assessment because it is a reported contributing 
factor in name confusion medication errors.  
  
FDA will evaluate the proposed container labels and other proposed external labeling to identify 
potential problems with the proposed design or presentation of information that could contribute 
to confusion in a real world environment and lead to medication errors. For example: 
 
  If critical information, such as the drug name and concentration, is not displayed prominently 
or is masked by more prominent but less critical information, these factors could contribute 
to confusion and possible medication errors.   
 
  11  Contains Nonbinding Recommendations 
 
  If product names are obscured by a logo or are illegible because of the font or color of the 
text, these factors could lead to name confusion or product selection errors.   
 
  The similar appearance of labels or labeling among different drugs or different dosage 
strengths of drugs could contribute to selection of an incorrect drug or product strength where 
product names are similar.   
 
The possibility of this type of error is increased when products have similar names.   
   
2.  Submission for a Product Without Proposed Labeling 
 
  If the proposed labeling is not available at the time of the proposed proprietary name submission, 
the following information should be provided for FDAs evaluation for the submission to be 
considered complete. (This information is normally contained in professional labeling.)   
 
a.  Established Name  
 
The submission should include the established name.  An established name could contribute to 
product name confusion.  For instance, if the established name itself is similar in appearance or 
pronunciation to the proprietary or established names of existing products, it may compound the 
potential for confusion if the proposed proprietary name of the product is also similar to other 
names.  In addition, the established name can factor into the choice of product storage location. 
For example, certain institutions store medications by established name, not proprietary name.  
Having the established name thus helps FDA to determine what other product names will likely 
be displayed on the pharmacy shelf in close proximity to the proposed proprietary name. 
 
b.  Prescription Status 
 
Prescription status affects storage location and clinical conditions of use.  Therefore, the 
submission should include information about whether the product will be available without a 
prescription and/or by prescription. If the product is a controlled substance listed in schedule II, 
III, IV, or V of the Federal Controlled Substances Act or implementing regulations, the 
submission should also include the assigned schedule (e.g., schedule II).  The submission should 
note if product scheduling is pending.  
 
c.  Dosage Form(s) 
 
The submission should include the finished dosage form, an important product characteristic for 
correct prescribing, dispensing, use, and storage of a product. 
 
d.  Product Strength(s) 
 
The submission should include all proposed product strengths, because product strength is an 
important consideration when prescribing and dispensing a product.  Product strength 
information is also important when determining potential confusion with other products and/or 
product line extensions.  For instance, errors in selection of a wrong product can occur because 
of overlapping strengths between products that are available in multiple dosage formulations.  
  12  Contains Nonbinding Recommendations 
 
Errors can also occur in selecting the correct product strength if the strengths are not presented 
clearly on the label or labeling.   
 
e.  Proposed Indication(s) for Use  
 
The submission should include the proposed indication(s) for use, which provides insight into the 
prescribing and patient populations and potential clinical care environments in which the product 
will be used and stored. 
 
f.  Route(s) of Administration 
 
The submission should include the route(s) of administration, which provides additional context 
to product prescribing, storage, dispensing, clinical care environment, and patient use.  For 
instance, the route of administration can influence the environment in which the product is 
prescribed (e.g., inpatient setting vs. outpatient setting) and prepared for dispensing (e.g., sterile 
vs. nonsterile) and ultimately the form in which the drug is administered (e.g., vial, IV admixture 
bag, tablet).  Similarities and/or dissimilarities in the routes of administration can affect the 
potential for medication errors. 
 
g.  Usual Dosage, Frequency of Administration, Dosing Interval, Maximum 
  Daily Dose 
 
The submission should include information about the proposed usual dosage, including the 
frequency of administration, the specific dosing interval, and the maximum daily dose.  
Similarities to or overlaps with other products in any of these areas can contribute to potential 
medication errors.  
 
h.  Dosing in Specific Populations  
 
The submission should include a description of dosing modifications that are dependent on renal 
and/or hepatic function, age, or gender.  This information provides insight into additional areas 
of potential overlap or similarity with other product lines or products in dosing or frequency of 
administration. 
 
i.  Instructions for Use  
 
The submission should include a detailed description of and step-by-step instructions for product 
use, if applicable, such as instructions for preparation and administration of IV products.  The 
description should communicate whether the product will be self-administered by the patient or 
will require a skilled health professional to administer it. Instructions-for-use information can 
help identify similarities with other products that, in combination with proprietary name 
similarities, could lead to product confusion.  
 
j.  Storage Requirement  
 
The submission should include the storage requirement for the product at all points in the 
medication-use system, both pre- and post-dispensing.  Storing products with similar names in 
  13  Contains Nonbinding Recommendations 
 
similar locations (for example, in a refrigerator) can contribute to medication errors in all levels 
of the medication-use system (warehouse, pharmacy, clinical care environment, or patient home).   
 
k.  How Supplied and Packaging Configuration   
 
The submission should include information detailing how the product will be supplied and 
packaged. This information should include a description of the proposed product packaging, such 
as blister packs or inhalers.  Product packaging is used by health care practitioners and 
consumers to select and administer the correct medication and dose and is the primary means by 
which practitioners and patients identify and use the product.  The submission should also 
include the product strength, net quantity/size of all containers, and whether the product will be 
supplied in any physician samples or starter packs. This information also helps to determine the 
potential for confusion of the proposed product with other products.  For instance, selection of 
the wrong product can occur where products with similar names also have similar net quantity, 
product strength, and/or packaging.  
 
D.  Information About Product Dispensing and Delivery 
 
All submissions should contain the following information about product dispensing and delivery 
for FDA to complete a proposed proprietary name review. 
 
1.  Likely Care Environment(s) for Dispensing and Use 
 
The submission should include a list of all the likely care environments for dispensing and use of 
the product.  For example, include information about whether the product is expected to be used 
in an inpatient/hospital setting, long-term care facility, clinic, doctors office, or home.  Also 
describe the proposed distribution of the product, such as whether the product is to be dispensed 
from a retail or hospital pharmacy setting or distributed directly from the manufacturer or select 
wholesaler.  This information provides insight into where an error might occur in the medication-
use system. 
 
2.  Delivery System 
 
If applicable, we recommend that the submission include a model and instructions for use of the 
product delivery system (e.g., transdermal patch) or product device (e.g., pen injector, inhaler). If 
no model is available, the submission should include a detailed description of the delivery system 
or device. Submitting this information allows FDA to assess the actual use of the product and 
identify possible similarities to a different product with a similar name.  
 
3.  Measuring Device 
 
If the product is to be dispensed with a measuring device (such as a calibrated dosing cup), we 
recommend that the submission include the device. If no sample device is available, you should 
include a description of the device, including its measuring calibration and any text or graphics 
to be printed on the device.  Submitting the measuring device allows FDA to assess whether 
products with similar names could be subject to product confusion and medication error based on 
similarities in dosing and administration or in overall appearance.  
 
  14  Contains Nonbinding Recommendations 
 
E.  Applicants Assessments of Proprietary Name, Packaging, and/or Labeling  
 
Applicants may include any assessments of the proprietary name, packaging, and/or labeling that 
were conducted or commissioned by the applicant or sponsor.  When submitted, this information 
will be considered in the Agencys review of the proprietary name, packaging, and labeling of a 
proposed product.  However, submission of such assessments will neither substitute for 
submission of the other information described in this guidance as constituting a complete 
submission, nor will FDA consider a submission incomplete because this information is not 
provided.  
 
 
V.  WHEN AND WHERE TO SEND A SUBMISSION FOR A PROPOSED 
PROPRIETARY NAME REVIEW 
 
FDA generally encourages applicants and sponsors to submit their requests for FDA review of 
proposed proprietary names as soon as they have the recommended supporting information as 
described in this guidance.  However, as explained in section II.E, if the request is submitted at 
the IND stage, it should be done no earlier than at the end of phase 2 of the IND process. 
   
The proposed proprietary name should be sent in as a separate submission.  The request for a 
proposed proprietary name review should be submitted to a pending NDA/BLA/ANDA or 
supplement. If such an application is not yet available, the submission should be submitted to an 
active IND. 
 
Submissions may be in paper or electronic format.  For paper submissions, the applicant or 
sponsor should submit three (3) copies of the submission to the same address as the original 
application with which the proprietary name is associated. For electronic submissions, see 
section V.C below. 
 
   
A.  Drug Products, Including Biologics, That Are the Subject of an IND, NDA, 
or BLA  Paper Submission 
 
1.  Submissions for Proposed Proprietary Names for Prescription Drugs, Including 
Biologics, That Are the Subject of an IND, NDA, or BLA Reviewed by CDER 
 
Center for Drug Evaluation and Research 
Food and Drug Administration 
Document and Records Section 
5901-B Ammendale Rd 
Beltsville, MD 20705-1266 
  15  Contains Nonbinding Recommendations 
 
 
2.  Submissions for Proposed Proprietary Names for Prescription Drugs, Including 
Biologics, That Are the Subject of an IND, NDA, or BLA Reviewed by CBER 
 
FDA/CBER 
Document Control Center, HFM-99 
1401 Rockville Pike, Suite 200N 
Rockville, MD 20852-1448 
 
3.  Submissions for Proposed Proprietary Names for Nonprescription Drugs That 
Are the Subject of an IND or NDA  
 
DHHS/FDA/CDER/ONP 
5901-B Ammendale Road 
Beltsville, MD 20705-1266 
 
B.  Drugs Products That Are the Subject of an ANDA  Paper Submission 
 
Center for Drug Evaluation and Research 
Food and Drug Administration 
Document and Records Section 
5901-B Ammendale Rd 
Beltsville, MD 20705-1266 
 
C.  Electronic Submissions 
 
Applicants and sponsors who want to provide a proposed proprietary name submission 
electronically to CDER or CBER should refer to the FDA eCTD web site at 
www.fda.gov/ectd 
Refer specifically to the following documents on that Web page: 
 
  Guidance for industry on Providing Regulatory Submissions in Electronic Format  
Human Pharmaceutical Product Applications and Related Submissions Using the 
eCTD Technical Conformance Guide 
Within the eCTD Submissions Standards document, you will find links to the following 
specifications: 
  eCTD Backbone File Specification for Module 1 
    The Comprehensive Table of Contents Headings and Hierarchy Version 2.3 
  FDA Portable Document Format (PDF) Specifications 
 Place the request for proposed proprietary name review and rationale information in 
eCTD section  1.18 Proprietary names.   The eCTD leaf title of the document should be 
clear, concise, and indicative of the documents content (e.g., REQUEST FOR 
PROPRIETARY NAME REVIEW, AMENDMENT TO REQUEST FOR 
PROPRIETARY NAME REVIEW, or REQUEST FOR RECONSIDERATION 
OF PROPRIETARY NAME).  Provide the eCTD location of the contents on the first 
page of the submission and, if possible, include cross-document links or external 
bookmarks to the information.  This approach will help ensure the information can be 
accessed quickly and easily. 
  16  Contains Nonbinding Recommendations 
 
 
Applicants and sponsors are encouraged to use the Electronic Submissions Gateway 
(ESG) to submit regulatory information.  For information on the use of the ESG, refer to 
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. 
 
 
  17  Contains Nonbinding Recommendations 
 
 
GLOSSARY 
 
Because this guidance covers a wide range of products regulated by the Center for Drug 
Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research 
(CBER), we have defined, for purposes of this document, a number of terms used in the 
guidance to enhance comprehension and avoid potential confusion.   
 
Applicant or sponsor:  The entity that submits a proposed proprietary name submission for the 
following types of products: 
  Prescription drugs products (including biologics) that are the subject of an NDA (21 CFR 
314.3(b)), a BLA (21 CFR 601.2), or an ANDA (21 CFR 314.92), or that are currently 
the subject of an IND (21 CFR 312.3(b)) in anticipation of submission in a marketing 
application 
  Nonprescription drug products that are the subject of an IND (21 CFR 312.3(b)), an NDA 
(21 CFR 314.3(b)), or an ANDA  (21 CFR 314.92) 
 
Complete submission:  The information FDA identifies for a sponsor or applicant to include to 
ensure that the Agency can conduct a complete review of a proposed proprietary name using our 
traditional review methods. 
 
Established name: The official name of the drug as defined under section 502(e)(3) of the Act 
(21 U.S.C. 352(e)(3)) and further described under 21 CFR 299.4, Established names for drugs; 
also known as proper name for biologics (see section 351(a)(1)(B)(ii) of the Public Health 
Service Act, 42 U.S.C. 262(a)(1)(B)(ii)). The established name is usually the name that has been 
derived by the U.S. Adopted Names Council (USAN). It is often the generic or common name of 
a product and can usually be found in the United States Pharmacopeia.  
 
Label:   As defined in section 201(k) of the Act, the term label means  
a display of written, printed, or graphic matter upon the immediate container of any 
article.  
 
Labeling:   As defined in section 201(m) of the Act, the term labeling means all labels and 
other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, 
or (2) accompanying such article.  Labeling includes outside containers, or wrappers, and 
package liners.   
 
Medical error:  The Institute of Medicine defines medical error as the failure of a planned 
action to be completed as intended or the use of a wrong plan to achieve an aim.24  Types of 
errors include diagnostic, treatment, preventive, and other (such as failure of communication, 
equipment, or system).25 
 
                                                 
24 IOM, To Err is Human.  Chapter 1, p. 1. 
 
25 Leape, L, Lawthers, AG, Brennan, TA, et al. Preventing Medical Injury. Qual Rev Bull. 19(5):144-149, 1993, 
cited in To Err is Human, p. 1. 
 
  18  Contains Nonbinding Recommendations 
 
Medication error:  The National Coordinating Council for Medication Error Reporting and 
Prevention describes 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. Such events may be related to professional practice, health 
care products, procedures, and systems, including prescribing; order 
communication; product labeling, packaging, and nomenclature; compounding; 
dispensing; distribution; administration; education; monitoring; and use.26  
 
Medication-use system:   The Institute of Medicine describes medication-use system as the 
system that  
encompasses the continuum of (1) prescribing by the clinician (or self-
prescribing), followed by transcribing; (2) preparing and dispensing by the 
pharmacist; (3) administering by the provider or consumer (self-care); and (4) 
monitoring for therapeutic and adverse effects (by nurse, surrogate, or self).  
Each of these steps includes critical control points at which decisions and actions 
can contribute to safety or errors.27 
 
Product characteristics:  The physical characteristics of the product itself (i.e., dosage form, 
strength, active ingredient) and environment in which the product is used, including but not 
limited to the established name, label, labeling, container, facility, storage conditions, who 
prescribes and administers the product, patient population, and other conditions of use. 
 
Proprietary name:  The trademark or brand name. 
  
                                                 
26 National Coordinating Council for Medication Error Reporting and Prevention Web site, 
http://www.nccmerp.org/aboutMedErrors.html. 
 
27 IOM, Preventing Medication Errors, Chapter 2, p. 67. 
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