CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`207154Orig1s000
`
`PROPRIETARY NAME REVIEW(S)
`
`
`
`
`
`

`

`PROPRIETARY NAME REVIEW
`Division of Medication Error Prevention and Analysis (DMEPA)
`Office of Medication Error Prevention and Risk Management (OMEPRM)
`Office of Surveillance and Epidemiology (OSE)
`Center for Drug Evaluation and Research (CDER)
`
`*** This document contains proprietary information that cannot be released to the public***
`
`Date of This Review:
`July 8, 2015
`Application Type and Number: NDA 207154
`Product Name and Strength:
`Aczone (Dapsone) Gel, 7.5%
`Product Type:
`Single ingredient product
`Rx or OTC:
`Rx
`Applicant/Sponsor Name:
`Allergan Inc.
`Submission Date:
`April 28, 2015
`Panorama #:
`2015-411667
`DMEPA Primary Reviewer:
`Carlos M Mena-Grillasca, RPh
`DMEPA Team Leader:
`Kendra Worthy, PharmD
`DMEPA Associate Director:
`Lubna Merchant, MS, PharmD
`
`Reference ID: 3789326
`
`

`

`Contents
`INTRODUCTION ........................................................................................................... 1
`1.1
`Regulatory History................................................................................................ 1
`1.2
`Product Information............................................................................................. 1
`RESULTS ....................................................................................................................... 2
`2.1
`Promotional Assessment...................................................................................... 2
`2.2
`Safety Assessment................................................................................................ 2
`CONCLUSIONS.............................................................................................................. 3
`3.1
`Comments to the Applicant ................................................................................. 4
`REFERENCES................................................................................................................. 5
`
`1
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`2
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`3
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`4
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`Reference ID: 3789326
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`

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`INTRODUCTION
`1
`This review evaluates the proposed proprietary name, Aczone, 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. The Applicant
`did not submit an external name study.
`
`REGULATORY HISTORY
`1.1
`Aczone (Dapsone) Gel, 5% (NDA 021794) was approved on July 7, 2005. The proposed
`proprietary name, Aczone, was found conditionally acceptable in the IND for the 7.5%
`gel formulation1.
`The applicant submitted the name, Aczone, for review during the NDA on April 28, 2015.
`
`PRODUCT INFORMATION
`1.2
`The following product information is provided in the April 18, 2014 proprietary name
`submission.
`Intended Pronunciation: ak-zōn
`
` Active Ingredient: dapsone
`Indication of Use: Topical treatment of acne vulgaris
`
` Route of Administration: Topical
` Dosage Form: Gel
` Proposed Strength: 7.5%
`Currently Marketed: 5%
` Proposed Dose and Frequency (7.5% strength): Apply approximately a pea-sized
`amount of ACZONE Gel, 7.5%, in a thin layer to the acne affected areas once daily.
`Current Dose and Frequency (5% strength): Apply approximately a pea-sized
`amount of ACZONE Gel, 5%, in a thin layer to the acne affected areas twice daily.
` How Supplied:
`Currently: 3 g laminate tube sample; 30 g, 60 g, 90 g laminate tube
`Proposed: 3 g laminate tube sample; 30 g, 60 g, 90 g airless pumps
`Storage: 20 - 25° C (68 - 76° F), excursions permitted to 15 - 30° C (59 - 86° F)
`
` Container and Closure Systems: n/a
`
`
`1 Mena-Grillasca, C. Proprietary Review for Aczone (IND 054440). Silver Spring (MD): FDA, CDER,
`OSE, DMEPA (US); Insert Date As 2014AUG08. RCM No.: 2014-17244.
`
`Reference ID: 3789326
`
`1
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`

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`RESULTS
`2
`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 Dermatology
`and Dental Products (DDDP) 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
`There is no USAN stem present in the proprietary name1.
`
`2.2.2 Components of the Proposed Proprietary Name
`The applicant indicated in their submission that the proposed name, Aczone, is derived
`from the existing product, Aczone (dapsone) Gel, 5%. This proprietary name is
`comprised of a single word that contains the letters ‘ac’, which are used as a
`pharmaceutical abbreviation for oral products that are meant to be taken “before
`meals”. However, since this is a topical product the letters ‘ac’ in the name are not
`misleading and cannot contribute to medication errors. Additionally, as noted above we
`did not retrieve any medication errors associated with name confusion with the name
`Aczone.
`The Applicant is proposing a new 7.5% strength for their product line. The proposed
`7.5% and the currently marketed 5% strengths share the same indication and dose;
`however, the frequency of administration differs (5% is applied twice daily vs. 7.5% is
`applied once daily). It is a common and accepted practice to have a product line with
`multiple formulations/dosage forms and strengths managed under one proprietary
`name. Therefore, given the precedent for using this naming convention, Aczone is an
`acceptable proprietary name for the 7.5% strength.
`
`
`1USAN stem search conducted on June 25, 2015.
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`Reference ID: 3789326
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`2
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`2.2.3 Comments from Other Review Disciplines at Initial Review
`
`In response to the OSE, May 26, 2015 e-mail, the Division of Dermatology and Dental
`
`Products (DDDP) did not fonNard any comments or concerns relating to the proposed
`
`proprietary name at the initial phase of the review.
`
`2.2.4 Medication Error Data Selection of Cases
`
`We searched the FDA Adverse Event Reporting System (FAERS) database using the
`
`strategy listed in Table 1 (see Appendix A for a description of FAERS database).
`
`Table 1: FAERS Search Strategy
`
`June 25. 2015
`
`Aczone [product name]
`
`MedDRA Search Strategy
`
`Product name confusion (PT)
`
`
`
`Medication error (PT)
`
`Intercepted medication error (PT)
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`Drug dispensing error (PT)
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`Intercepted drug dispensing error (PT)
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`Circumstance or information capable of leading to a
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`medication error (PT)
`
`July 1, 2014 to June 1, 2015.
`
`Time/Date Limits
`
`Last FAERS search performed for OSE review 2014-
`
`17244, dated August 21, 2014, was on July 1, 2014.
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`The FAERS database search did not retrieve any cases.
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`2.2.5 Communication of DMEPA’s Analysis at Midpoint of Review
`
`DMEPA communicated our findings to the Division of Dermatology and Dental Products
`
`(DDDP) via e-mail on July 7, 2015. At that time we also requested additional
`
`information or concerns that could inform our review. Per e-mail correspondence from
`
`the DDDP on July 7, 2015, they stated no additional concerns with the proposed
`
`proprietary name Aczone.
`
`3
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`CONCLUSIONS
`
`The proposed proprietary name is acceptable from both a promotional and safety
`
`perspective.
`
`If you have further questions or need clarifications, please contact Janet Anderson, OSE
`
`project manager, at 301-796-0675.
`
`Reference ID: 3789326
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`

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`COMMENTS TO THE APPLICANT
`3.1
`We have completed our review of the proposed proprietary name, Aczone, and have
`concluded that this name is acceptable.
`If any of the proposed product characteristics as stated in your April 28, 2015
`submission are altered prior to approval of the marketing application, the name must be
`resubmitted for review.
`
`Reference ID: 3789326
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`4
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`

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`4
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`REFERENCES
`
`1. USAN Stems (http://www.ama-assn.org/ama/pub/physician-resources/medical-
`science/united-states-adopted-names-council/naming-guidelines/approved-
`stems.page)
`USAN Stems List contains all the recognized USAN stems.
`
`2. FDA Adverse Event Reporting System (FAERS)
`
`The FDA Adverse Event Reporting System (FAERS) is a database that contains
`information on adverse event and medication error reports submitted to FDA. The
`database is designed to support the FDA's postmarket safety surveillance program
`for drug and therapeutic biologic products. The informatic structure of the FAERS
`database adheres to the international safety reporting guidance issued by the
`International Conference on Harmonisation. FDA’s Office of Surveillance and
`Epidemiology codes adverse events and medication errors to terms in the Medical
`Dictionary for Regulatory Activities (MedDRA) terminology. Product names are
`coded using the FAERS Product Dictionary. More information about FAERS can be
`found at:
`http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance
`/AdverseDrugEffects/default.htm.
`
`APPENDICES
`Appendix A
`FDA’s Proprietary Name Risk Assessment considers the promotional and safety aspects of a
`proposed proprietary name.
`1. Promotional Assessment: For prescription drug products, the promotional review of the
`proposed name is conducted by OPDP. For over-the-counter (OTC) drug products, the
`promotional review of the proposed name is conducted by DNCE. OPDP or DNCE
`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 or DNCE
`provides their opinion to DMEPA for consideration in the overall acceptability of the
`proposed proprietary name.
`2. Safety Assessment: The safety assessment is conducted by DMEPA, and includes the
`following:
`a. Preliminary Assessment: We consider inclusion of USAN stems or other characteristics
`that when incorporated into a proprietary name may cause or contribute to medication
`errors (i.e., dosing interval, dosage form/route of administration, medical or product
`name abbreviations, names that include or suggest the composition of the drug
`product, etc.) See prescreening checklist below in Table 2*. DMEPA defines a
`medication error as any preventable event that may cause or lead to inappropriate
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`Reference ID: 3789326
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`5
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`medication use or patient harm while the medication is in the control of the health care
`professional, patient, or consumer. I
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`*Table 2- Prescreening Checklist for Proposed Proprietary Name
`
`Affirmative answers to these questions indicate a potential area of
`concern.
`
`iz
`
`Does the name have obvious Similarities in Spelling and Pronunciation to other
`Names?
`
`iH
`iz
`
`iz
`iH
`
`
`
`Are there Medical and/or Coined Abbreviations in the Proprietary Name?
`
`Is this the same Proprietary Name for Products containing Different Active
`
`Ingredients?
`
`Is this a Proprietary Name of a discontinued product?
`
`b. 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’5 assessment.
`
`The OND/OGD Regulatory Division is contacted a second time following our analysis of the
`proposed proprietary name. At this point, DM EPA conveys their decision to accept or reject
`
`the name. The OND or 060 Regulatory Division is requested to provide any further
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`information that might inform DMEPA’s final decision on the proposed name.
`
`Additionally, other review disciplines opinions such as ONDQA or OBP may be considered
`
`depending on the proposed proprietary name.
`
`When provided, DMEPA considers external proprietary name studies conducted by or for the
`Applicant/Sponsor and incorporates the findings of these studies into the overall risk
`assessment.
`
`The DMEPA primary reviewer assigned to evaluate the proposed proprietary name is
`
`responsible for considering the collective findings, and provides an overall risk assessment of the
`
`proposed proprietary name.
`
`1 National Coordinating Council for Medication Error Reporting and Prevention.
`httQ:z[www.nccmerp.org[aboutMedErrors.html. Last accessed 10/11/2007.
`
`Reference ID: 3789326
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`CARLOS M MENA-GRILLASCA
`07/08/2015
`
`KENDRA C WORTHY
`07/10/2015
`
`LUBNA A MERCHANT
`07/10/2015
`
`Reference ID: 3789326
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