CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`214324Orig1s000
`
`PROPRIETARY NAME REVIEW(S)
`
`
`
`
`
`

`

`PROPRIETARY NAME MEMORANDUM
`Division of Medication Error Prevention and Analysis 2 (DMEPA 2)
`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:
`February 15, 2022
`Application Type and Number: NDA 214324
`Product Name and Strength:
`Tyvaso DPI (treprostinil) inhaler, 16 mcg, 32 mcg, 48
`mcg, and 64 mcg
`Combination Product (Drug-Device)
`Prescription (Rx)
`United Therapeutics Corporation (UTC)
`2021-1044724359
`Maximilian Straka, PharmD, FISMP
`Hina Mehta, PharmD
`Chi-Ming Tu, PharmD, BCPS
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`PNR ID #:
`DMEPA 2 Safety Evaluator:
`DMEPA 2 Team Leader:
`DMEPA 2 Associate Director
`for Nomenclature and
`Labeling:
`
`Reference ID: 4939945
`
`

`

`INTRODUCTION
`1
`This memorandum is to reassess the proposed proprietary name, Tyvaso DPI, which was found
`conditionally acceptable under IND 134582 on October 15, 2020a and under NDA 214324 on
`June 9, 2021b. However, the Application received a Complete Response on October 15, 2021.
`UTC resubmitted the proposed proprietary name Tyvaso DPI under NDA 214324 for review on
`December 23, 2021. 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 Tyvaso DPI would not
`misbrand the proposed product. The Division of Medication Error Prevention and Analysis 2
`(DMEPA 2) and the Division of Cardiology and Nephrology (DCN) concurred with the findings
`of OPDP’s assessment for Tyvaso DPI.
`
`SAFETY ASSESSMENT
`2.2
`For re-assessment of the proposed proprietary name, we 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. Our reassessment did not change our conclusion regarding the previously identified names
`of concern. Additionally, we searched the United States Adopted Name (USAN) stem list to
`determine if the proposed proprietary name contains any USAN stems as of the last USAN
`updates. The February 2, 2022 search of USAN stems did not find any USAN stems in the
`proposed proprietary name, Tyvaso DPI.
`
`2.3 COMMUNICATION OF DMEPA’S DETERMINATION
`On February 11, 2022 we communicated our determination to the Division of Cardiology and
`Nephrology (DCN).
`
`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, Tyvaso DPI, is
`acceptable.
`If you have any questions or need clarifications, please contact Wana Manitpisitkul, OSE project
`manager, at (240) 402-4156.
`
`a Aidoo, M. Proprietary Name Review for Tyvaso DPI (IND 134582). Silver Spring (MD): FDA, CDER, OSE,
`DMEPA (US); 2020 OCT 15. Panorama No.: 2020-39356814.
`b Aidoo, M. Proprietary Name Review Memo for Tyvaso DPI (NDA 214324). Silver Spring (MD): FDA, CDER,
`OSE, DMEPA (US); 2021 JUN 9. Panorama No.: 2021-1044723937.
`
`Reference ID: 4939945
`
`

`

`3.1 COMMENTS TO UNITED THERAPEUTICS CORPORATION
`We have completed our review of the proposed proprietary name, Tyvaso DPI, and have
`concluded that this name is acceptable.
`If any of the proposed product characteristics as stated in your submission, received on
`December 23, 2021, are altered prior to approval of the marketing application, the name must be
`resubmitted for review.
`
`Reference ID: 4939945
`
`

`

`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: 4939945
`
`

`

`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/
`------------------------------------------------------------
`
`MAXIMILIAN STRAKA
`02/17/2022 12:30:30 PM
`
`HINA S MEHTA
`02/17/2022 01:43:23 PM
`
`CHI-MING TU
`02/17/2022 01:57:13 PM
`
`Reference ID: 4939945
`
`

`

`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:
`June 9, 2021
`Application Type and Number: NDA 214324
`Product Name and Strength:
`Tyvaso DPI (treprostinil) inhaler, 16 mcg, 32 mcg, 48
`mcg, and 64 mcg
`Combination Product (Drug-Device)
`Prescription (Rx)
`United Therapeutics Corporation (UTC)
`2021-1044723937
`Mariette Aidoo, PharmD, MPH
`Hina Mehta, PharmD
`Chi-Ming Tu, PharmD, BCPS
`
`Product Type:
`Rx or OTC:
`Applicant/Sponsor Name:
`Panorama or PNR ID #:
`DMEPA Safety Evaluator:
`DMEPA Team Leader:
`DMEPA Associate Director of
`Nomenclature and Labeling
`
`Reference ID: 4812877
`
`

`

`INTRODUCTION
`1
`This memorandum is to reassess the proposed proprietary name, Tyvaso DPI, which was found
`conditionally acceptable under IND 134582 on October 15, 2020.a Thus, UTC submitted the
`name, Tyvaso DPI, under NDA 214324 for review on April 22, 2021. 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 Tyvaso DPI would not
`misbrand the proposed product. The Division of Medication Error Prevention and Analysis
`(DMEPA) and the Division of Cardiology and Nephrology (DCN) concurred with the findings of
`OPDP’s assessment for Tyvaso DPI.
`
`SAFETY ASSESSMENT
`2.2
`For re-assessment of the proposed proprietary name, we again evaluated the proposed
`proprietary name (the use of the same root name and the modifier DPI) considering any lessons
`learned from recent post-marketing experience, which may have altered our previous conclusion
`regarding the acceptability of the proposed proprietary name. Our reassessment did not change
`our conclusion. Additionally, we searched the United States Adopted Name (USAN) stem list to
`determine if the proposed proprietary name contains any USAN stems as of the last USAN
`updates. The May 4, 2021 search of USAN stems did not find any USAN stems in the proposed
`proprietary name, Tyvaso DPI.
`
`2.3 COMMUNICATION OF DMEPA’S ANALYSIS AT MIDPOINT OF REVIEW
`We communicated our findings to the Division of Cardiology and Nephrology (DCN). At that
`time we also requested additional information or concerns that could inform our review. On
`June 7, 2021, the Division of Cardiology and Nephrology (DCN) stated no additional concerns
`with the proposed proprietary name, Tyvaso DPI.
`
`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, Tyvaso DPI, is
`acceptable.
`
`a Aidoo, M. Proprietary Name Review for Tyvaso DPI (IND 134582). Silver Spring (MD): FDA, CDER, OSE,
`DMEPA (US); 2020 OCT 15. Panorama No.: 2020-39356814.
`
`Reference ID: 4812877
`
`

`

`If you have any questions or need clarifications, please contact Wana Manitpisitkul, OSE project
`manager, at (240) 402-4156.
`
`3.1 COMMENTS TO UNITED THERAPEUTICS CORPORATION
`We have completed our review of the proposed proprietary name, Tyvaso DPI, and have
`concluded that this name is acceptable.
`If any of the proposed product characteristics as stated in your submission, received on April 22,
`2021, are altered prior to approval of the marketing application, the name must be resubmitted
`for review.
`
`Reference ID: 4812877
`
`

`

`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: 4812877
`
`

`

`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/
`------------------------------------------------------------
`
`MARIETTE A AIDOO
`06/09/2021 12:20:35 PM
`
`HINA S MEHTA
`06/09/2021 03:00:25 PM
`
`CHI-MING TU
`06/17/2021 09:12:39 AM
`
`Reference ID: 4812877
`
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