`RESEARCH
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`APPLICATION NUMBER:
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`210259Orig1s000
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`PROPRIETARY NAME REVIEW(S)
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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)
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`*** This document contains proprietary information that cannot be released to the
`public***
`
`Date of This Review:
`August 23, 2017
`Application Type and Number: NDA 210259
`Product Name and Strength:
`Calquence (acalabrutinib) capsule, 100 mg
`Product Type:
`Single ingredient
`Rx or OTC:
`Rx
`Applicant/Sponsor Name:
`Acerta Pharma B.V.
`Panorama #:
`2017-15712155
`DMEPA Safety Evaluator:
`Casmir Ogbonna, PharmD, MBA, BCPS, BCGP
`DMEPA Team Leader:
`Hina Mehta, PharmD
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`Reference ID: 4143034
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`(
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`INTRODUCTION
`1
`This memorandum is to reassess the proposed proprietary name, Calquence, which was found
`conditionally acceptable under IND 118717 on November 8, 2016.a We note that all product
`characteristics remain the same.
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`2 METHODS AND DISCUSSION
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`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 Hematologic Products (DHP)
`concurred with the findings of OPDP’s assessment of the proposed name.
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`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 July 28, 2017, search of USAN stems did not
`find any USAN stems in the proposed proprietary name.
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`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.
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`If you have any questions or need clarifications, please contact Neil Vora, OSE project manager,
`at 240-402-4845.
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`3.1 COMMENTS TO THE APPLICANT
`We have completed our review of the proposed proprietary name, Calquence, and have
`concluded that this name is acceptable.
`If any of the proposed product characteristics as stated in your June 16, 2017, submission are
`altered prior to approval of the marketing application, the name must be resubmitted for review.
`
`a Rychlik, I. Proprietary Name Review for Calquence (IND 118717). Silver Spring (MD): Food and Drug
`Administration, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, Division of
`Medication Error Prevention and Analysis (US); 2016 NOV 08. Panorama No. 2016-9658497.
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`Reference ID: 4143034
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`4 REFERENCES
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`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.
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`Reference ID: 4143034
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`
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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/
`----------------------------------------------------
`
`CASMIR I OGBONNA
`08/23/2017
`
`HINA S MEHTA
`08/24/2017
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`Reference ID: 4143034
`
`