CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`209606Orig1s000
`
`PROPRIETARY NAME REVIEW(S)
`
`
`
`
`
`
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`209606Orig1s000
`
`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 21, 2017
`Application Type and Number: NDA 209606
`Product Name and Strength:
`Idhifa (enasidenib) tablet, 50 mg (equivalent to 60
`mg enasidenib mesylate) and 100 mg (equivalent to
`120 mg enasidenib mesylate)
`Single ingredient
`Rx
`Celgene Corporation
`2017-12352686
`Susan Rimmel, PharmD
`Hina Mehta, PharmD
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Team Leader:
`
`Reference ID: 4072563
`
`
`
`1
`
`INTRODUCTION
`
`This memorandum is to reassess the proposed proprietary name, Idhifa, which was found
`conditionally acceptable under IND 117631 on September 20, 2016.*
`
`Wenote that there is a change in product strength, salt equivalency, dose frequency and duration,
`and maximum daily dose for NDA 209606. All other product characteristics remain the same.
`Table 1 outlines the differences for this submission.
`
`Table 1. Product Characteristic Submission Differences
`
`
`
`Product Characteristic|IND 117631 NDA 209606
`
`50 mg and 100 mg
`50 mg, 100,
`Strength
`
`
`Salt Equivalency
`
`none specified
`
`
`
`
`
`
`
`Dose Frequency and The recommended|The recommendedstarting dose is 100 mg
`
`
`Duration starting dose is 100|once daily until disease progression or
`mg oncedaily|
`unacceptable toxicity.
`Treat patients for a minimum of 6 months to
`allow time for clinical response. Treatment
`should be continuedas long as the patient
`Dosing is continued|continues to benefit.
`or modified based
`a
`.
`uponclinical and
`laboratory findings. Dose Adjustment for Toxicities
`iDoseAdjustmentforToxicities
`IDH Differentiation Syndrome
`
`50 mg (equivalent to 60 mg enasidenib
`mesylate )
`
`100 mg (equivalent to 120 mg enasidenib
`mesylate)
`
`¢ Administer systemic corticosteroids.
`
`¢ Interrupt IDHIFA if severe pulmonary
`symptoms and/or renal dysfunction persist
`after 48 hours of treatment with systemic
`corticosteroids.
`
`¢ Resume IDHIFA when symptoms improve.
`
`Other Grade 3 or Higher Toxicity Considered
`Related to Treatment
`
`¢ Interrupt IDHIFA until toxicity resolves.
`
`
`
`@ Garrison, N. Proprietary Name Review for Idhifa (IND 117631). 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 SEP 20. Panorama No. 2016-7936729.
`
`Reference ID: 4072563
`
`
`
`• Resume IDHIFA at 50 mg daily; may
`increase to 100 mg daily if patient continues to
`tolerate therapy.
`• Stop therapy if patient does not tolerate 50
`mg daily.
`none specified
`
`Maximum Daily Dose
`
`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 Hematology Products (DHP)
`concurred with the findings of OPDP’s assessment of the proposed name.
`
`SAFETY ASSESSMENT
`2.2
`For reassessment 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. We also evaluated previously identified names taking into account the change in product
`strength, dose frequency and duration, and maximum daily dose. Our evaluation has not 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 March 3, 2017, search of USAN stems did not
`find any USAN stems in the proposed proprietary name.
`
`3 CONCLUSIONS
`Our reassessment 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 Neil Vora, OSE project manager,
`at 240-402-4845.
`
`3.1 COMMENTS TO THE APPLICANT
`We have completed our review of the proposed proprietary name, Idhifa, and have concluded
`that this name is acceptable.
`If any of the proposed product characteristics as stated in your December 30, 2016, and January
`4, 2017, submission are altered prior to approval of the marketing application, the name must be
`resubmitted for review.
`
`Reference ID: 4072563
`
`(b) (4)
`
`
`
`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: 4072563
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`SUSAN RIMMEL
`03/21/2017
`
`HINA S MEHTA
`03/22/2017
`
`Reference ID: 4072563
`
`
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