`RESEARCH
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`APPLICATION NUMBER:
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`205834Orig1s000
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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***
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`Date of This Review:
`April 29, 2014
`Requesting Office or Division:
`Division of Antiviral Products (DAVP)
`Application Type and Number: NDA 205834
`Product Name and Strength:
`Harvoni (Ledipasvir and Sofosbuvir) Tablets
`90 mg/400 mg
`Single ingredient product
`Rx
`Gilead Sciences
`02/28/2014
`2014-17039
`James Schlick, RPh, MBA
`Irene Z. Chan, PharmD, BCPS
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Submission Date:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Associate Director:
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`Reference ID: 3497734
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`1
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`1
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`INTRODUCTION
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`The proposed proprietary name, Harvoni, was found acceptable in OSE review # 2013-
`2662, dated February 7, 2014 under IND 115268. This memorandum is to communicate
`that DMEPA maintains the proposed proprietary name, Harvoni, is acceptable from both a
`promotional and safety perspective under the NDA 205834.
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`If you have further questions or need clarifications, please contact Danyal Chaudhry, OSE
`project manager, at 301-796-3813.
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`1.1 COMMENTS TO THE APPLICANT
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`We have completed our review of the proposed proprietary name, Harvoni, and have
`concluded that this name is acceptable.
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`If any of the proposed product characteristics as stated in your February 28, 2014
`submission are altered, the name must be resubmitted for review.
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`Reference ID: 3497734
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`2
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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/
`----------------------------------------------------
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`JAMES H SCHLICK
`04/29/2014
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`IRENE Z CHAN
`04/29/2014
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`Reference ID: 3497734
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`