`RESEARCH
`
`
`APPLICATION NUMBER:
`
`206276Orig1s000
`
`PROPRIETARY NAME REVIEW(S)
`
`
`
`
`
`
`
`PROPRIETARY NAME REVIEW 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 4, 2014
`Application Type and Number: NDA 206276
`Product Name and Strength:
`Pazeo (Olopatadine hydrochloride) Ophthalmic Solution,
`0.77%
`Single Ingredient Product
`Rx
`Alcon
`October 15, 2014
`2014-39505
`Rachna Kapoor, PharmD
`Yelena Maslov, PharmD
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Submission Date:
`Panorama #:
`DMEPA Primary Reviewer:
`DMEPA Associate Director:
`
`Reference ID: 3667658
`
`1
`
`
`
`Contents
`INTRODUCTION ............................................................ Error! Bookmark not defined.
`1.1
`Comments to the Applicant ................................................................................. 1
`REFERENCES................................................................................................................. 2
`
`1
`
`2
`
`Reference ID: 3667658
`
`2
`
`
`
`INTRODUCTION
`1
`The proposed proprietary name, Pazeo, was found acceptable in OSE Review #2013-
`16781, dated May 19, 2014 under IND 060991. We note that product characteristics are
`the same for NDA 206276 currently under review as the IND. This memorandum is to
`communicate that DMEPA maintains the proposed proprietary name, Pazeo, is
`acceptable from both a promotional and safety perspective under the NDA 206276.
`If you have further questions or need clarifications, please contact Karen Townsend, OSE
`project manager, at 301-796-5413.
`
`COMMENTS TO THE APPLICANT
`2
`We have completed our review of the proposed proprietary name, Pazeo, and have
`concluded that this name is acceptable.
`If any of the proposed product characteristics as stated in your October 15, 2014
`submission are altered, the name must be resubmitted for review.
`
`Reference ID: 3667658
`
`3
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`
`
`REFERENCES
`
`1. Kapoor R and Maslov Y. Proprietary name review for Pazeo (IND 060991). 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); May 19, 2014. OSE RCM No.: 2013-16781.
`
`Reference ID: 3667658
`
`4
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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/
`----------------------------------------------------
`
`RACHNA KAPOOR
`12/04/2014
`
`YELENA L MASLOV
`12/09/2014
`
`Reference ID: 3667658
`
`
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