CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`212640Orig1s000
`
`PROPRIETARY NAME REVIEW(S)
`
`
`
`
`
`

`

`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:
`March 19, 2019
`Application Type and Number: NDA 212640
`Product Name and Strength:
`Exservan (riluzole) oral film, 50 mg
`Product Type:
`Single-Ingredient Product
`Rx or OTC:
`Prescription (Rx)
`Applicant/Sponsor Name:
`Aquestive Therapeutics
`Panorama #:
`2019-29064942
`DMEPA Safety Evaluator:
`Briana Rider, PharmD
`DMEPA Team Leader:
`Lolita White, PharmD
`
`
`
`Reference ID: 4405624Reference ID: 4525554
`
`

`

`INTRODUCTION
`1
`This memorandum is to reassess the proposed proprietary name, Exservan, which was found
`conditionally acceptable under IND 130939 on October 1, 2018.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 Exservan would not
`misbrand the proposed product. The Division of Medication Error Prevention and Analysis
`(DMEPA) and the Division of Neurology Products (DNP) concurred with the findings of
`OPDP’s assessment for Exservan.
`
`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 proposed
`proprietary name contains any USAN stems as of the last USAN updates. The February 11, 2019
`search of USAN stems did not find any USAN stems in the proposed proprietary name,
`Exservan.
`
`2.3 COMMUNICATION OF DMEPA’S ANALYSIS AT MIDPOINT OF REVIEW
`DMEPA communicated our findings to the Division of Neurology Products (DNP) via e-mail on
`March 11, 2019. At that time, we also requested additional information or concerns that could
`inform our review. Per e-mail correspondence from the Division of Neurology Products (DNP)
`on March 18, 2019, they stated no additional concerns with the proposed proprietary name,
`Exservan.
`
`3 CONCLUSION
`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, Exservan, is acceptable.
`
`If you have any questions or need clarifications, please contact Monique Killen, OSE project
`manager, at 240-402-1985.
`
`a Rider, B. Proprietary Name Review for Exservan (IND 130939). Silver Spring (MD): FDA, CDER, OSE, DMEPA
`(US); 2018 OCT 01. Panorama No.: 2018-22237515.
`
`
`
`Reference ID: 4405624Reference ID: 4525554
`
`

`

`3.1 COMMENTS TO AQUESTIVE THERAPEUTICS
`We have completed our review of the proposed proprietary name, Exservan, and have concluded
`that this name is acceptable.
`If any of the proposed product characteristics as stated in your submission, received on January
`31, 2019, are altered prior to approval of the marketing application, the name must be
`resubmitted for review.
`
`
`
`Reference ID: 4405624Reference ID: 4525554
`
`

`

`4 REFERENCE
`
`1. USAN Stems (https://www.ama-assn.org/about/united-states-adopted-names-
`approved-stems)
`USAN Stems List contains all the recognized USAN stems.
`
`
`
`Reference ID: 4405624Reference ID: 4525554
`
`

`

`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`BRIANA B RIDER
`03/19/2019 08:57:17 AM
`
`LOLITA G WHITE
`03/19/2019 11:27:29 AM
`
`
`
`Reference ID: 4405624Reference ID: 4525554
`
`