CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`210455Orig1s000
`
`PROPRIETARY NAME REVIEW(S)
`
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`
`
`
`

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`PROPRIETARY NAME MEMORANDUM
`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:
`December 04, 2017
`Application Type and Number: NDA 210455
`Product Name and Strength:
`Symtuza (darunavir, cobicistat, emtricitabine, and
`tenofovir alafenamide) Tablets,
`800 mg/150 mg/200 mg/10 mg
`Multi-Ingredient Product
`Rx
`Janssen Research & Development, LLC
`2017-17789081
`Valerie S. Wilson, PharmD
`Otto L. Townsend, PharmD
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Panorama #:
`DMEPA Safety Evaluator:
`DMEPA Team Leader:
`
`Reference ID: 4189720
`
`

`

`INTRODUCTION
`1
`This memorandum is to reassess the proposed proprietary name, Symtuza, which was found
`conditionally acceptable under IND 113456 on April 21, 2017.a We note that all product
`characteristics remain the same.
`
`2 METHODS AND DISCUSSION
`
`2.1 MISBRANDING ASSESSMENT
`The Office of Prescription Drug Promotion (OPDP) determined that the proposed name would
`not misbrand the proposed product. DMEPA and the Division of Antiviral Products (DAVP)
`concurred with the findings of OPDP’s assessment of the proposed name.
`
`SAFETY ASSESSMENT
`2.2
`For re-assessment of the proposed proprietary name, DMEPA evaluated the previously identified
`names of concern considering any lessons learned from recent post-marketing experience, which
`may have altered our previous conclusion regarding the acceptability of the proposed proprietary
`name. Additionally, DMEPA searched the USAN stem list to determine if the name contains any
`USAN stems as of the last USAN updates. The October 5, 2017 search of USAN stems did not
`find any USAN stems in the proposed proprietary name.
`
`2.3 COMMUNICATION OF DMEPA’S ANALYSIS AT MIDPOINT OF REVIEW
`DMEPA communicated our findings to the Division of Division of Antiviral Products (DAVP)
`via e-mail on November 8, 2017. At that time, we also requested additional information or
`concerns that could inform our review. Per e-mail correspondence from the DAVP on
`November 15, 2017, they stated concern for name confusion between the proposed proprietary
`names, Cimduo*** and Symtuza.
`We evaluated the name pair further to determine if there is sufficient orthographic, phonetic, and
`product characteristic differences to mitigate the risk of name confusion.
`Phonetically, the third syllables of this name pair (i.e. -zah and -oh) sound different. We
`acknowledge that the 2nd syllables of this name pair (i.e. -toó-and -DEW-) could sound similar
`when spoken; however, we note that during the verbal DMPEA prescription studies, there was
`no misinterpretation of the /t/ sound for the /d/ sound in Symtuza. Likewise, during the verbal
`DMEPA prescription studies for Cimduo***, there was no misinterpretation of the /d/sound for
`the /t/sound.
`Orthographically, Symtuza begins with the letter “S” that when scripted looks different from the
`beginning letter “C” in Cimduo***. Symtuza*** contains the down-stroke letter “y” in its prefix
`and the cross-stroke letter “t” in its suffix which is not contained in Cimduo***. The letter “z” in
`Symtuza*** affords an additional orthographic difference whether scripted as a down-stroke or
`scripted without a downstroke.
`
`a Roosta, N. Proprietary Name Review for Symtuza IND 113456 Silver Spring (MD): FDA, CDER, OSE, DMEPA
`(US); 2017 APR 21. Panorama No. 2016-12078665.
`
`Reference ID: 4189720
`
`

`

`Additionally, there is no numerical similarity or numerical overlap between the strengths of these
`two products.
`Based on the above, we find there is a sufficient combination of orthographic, phonetic, and
`product characteristic differences to mitigate confusion between this name pair. This is further
`supported by a combined POCA score of 48%, which indicates this name pair has low similarity.
`
`3 CONCLUSIONS
`Our re-assessment did not identify any names that represent a potential source of drug name
`confusion. Therefore, we maintain that the proposed proprietary name is acceptable.
`
`If you have any questions or need clarifications, please contact Danyal Chaudhry, OSE project
`manager, at 301-796-3813.
`
`3.1 COMMENTS TO THE APPLICANT
`We have completed our review of the proposed proprietary name, Symtuza, and have concluded
`that this name is acceptable.
`If any of the proposed product characteristics as stated in your September 22, 2017 submission
`are altered prior to approval of the marketing application, the name must be resubmitted for
`review.
`
`Reference ID: 4189720
`
`

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`4 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.
`
`Reference ID: 4189720
`
`

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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/
`----------------------------------------------------
`
`VALERIE S WILSON
`12/04/2017
`
`OTTO L TOWNSEND
`12/04/2017
`
`Reference ID: 4189720
`
`(
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