CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`
`203441Orig1s000
`
`PROPRIETARY NAME REVIEW(S)
`
`
`
`
`
`

`

`
`
`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`Office of Medication Error Prevention and Risk Management
`
`
`Proprietary Name Review--Final
`
`Date:
`
`
`
`November 19, 2012
`
`
`
`Reviewer(s):
`
`
`
`Team Leader:
`
`
`Drug Name(s) and Strength(s):
`
`Lissa C. Owens, PharmD
`Division of Medication Error Prevention and Analysis
`Lubna Merchant, M.S., PharmD
`Division of Medication Error Prevention and Analysis
`Gattex (Teduglutide [rDNA origin]) for Injection
`5 mg/vial
`NDA 203441
`
`Application Type/Number:
`NPS Pharmaceuticals
`
`Applicant/sponsor:
`2012-1866
`
`OSE RCM #:
`*** This document contains proprietary and confidential information that should not be released to
`the public.***
`
`
`
`
`Reference ID: 3218627
`
`
`
`
`
`
`
`
`
`
`
`
`1
`
`

`

`
`
`CONTENTS
`INTRODUCTION......................................................................................................................................... 3
`1
`2 METHODS AND DISCUSSION.................................................................................................................. 3
`3 CONCLUSIONS........................................................................................................................................... 3
`4 REFERENCES.............................................................................................................................................. 4
`
`Reference ID: 3218627
`
`
`2
`
`

`

`
`
` 1
`
`
`INTRODUCTION
`This re-assessment of the proposed proprietary name, Gattex is written in response to the anticipated
`approval of this NDA within 90 days from the date of this review. DMEPA found the proposed name,
`Gattex, acceptable in OSE Review RCM # 2011-4409 dated February 22, 2012.
`
`2 METHODS AND DISCUSSION
`For re-assessments of proposed proprietary names, DMEPA searches a standard set of databases and
`information sources (see section 4) to identify names with orthographic and phonetic similarity to the
`proposed name that have been approved since the previous OSE proprietary name review. For this
`review we used the same search criteria described in OSE Review RCM # 2011-4409. We note that
`none of the proposed product characteristics were altered. However, 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. The searches of the databases yielded no new names, thought to look or sound
`similar to Gattex and represent a potential source of drug name confusion.
`Additionally, DMEPA searched the USAN stem list to determine if the name contains any USAN
`stems as of the last USAN updates. The Safety Evaluator did not identify any United States Adopted
`Names (USAN) stems in the proposed proprietary name, as of November 6, 2012. The Office of
`Prescription Drug Promotion OPDP re-reviewed the proposed name on October 4, 2012 and had no
`concerns regarding the proposed name from a promotional perspective.
`
`3 CONCLUSIONS
`The re-evaluation of the proposed proprietary name, Gattex, did not identify any vulnerabilities that
`would result in medication errors with any additional names. Thus, DMEPA has no objection to the
`proprietary name, Gattex, for this product at this time.
`DMEPA considers this a final review; however, if approval of the NDA is delayed beyond 90 days
`from the date of this review, the Division of Gastroenterology and Inborn Errors Products should
`notify DMEPA because the proprietary name must be re-reviewed prior to the new approval date.
`If you have further questions or need clarifications, please contact Franklin Stephenson, OSE project
`manager, at 301-796-3872.
`
`
`Reference ID: 3218627
`
`
`3
`
`

`

`
`
`4 REFERENCES
`1.
`OSE Reviews: Siahpoushan, Manizheh., OSE RCM #2011-4409, Proprietary Name Review for Gattex
`(NDA 203441), February 22, 2012
`
`Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm)
`Drugs@FDA contains most of the drug products approved since 1939. The majority of labels,
`approval letters, reviews, and other information are available for drug products approved from 1998 to
`the present. Drugs@FDA contains official information about FDA approved brand name, generic
`drugs, therapeutic biological products, prescription and over-the-counter human drugs and discontinued
`drugs and “Chemical Type 6” approvals.
`
`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.
`
`Division of Medication Error Prevention and Analysis Proprietary Name Consultation Request
`Compiled list of proposed proprietary names submitted to the Division of Medication Error Prevention
`and Analysis for review. The list is generated on a weekly basis from the Access database/tracking
`system.
`
`2.
`
`3.
`
`4.
`
`
`
`Reference ID: 3218627
`
`
`4
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`LISSA C OWENS
`11/19/2012
`
`LUBNA A MERCHANT
`11/19/2012
`
`Reference ID: 3218627
`
`

`

`
`
`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`Office of Medication Error Prevention and Risk Management
`
`
`Proprietary Name Review—Final
`
`Date:
`
`
`
`July 26, 2012
`
`
`
`Reviewer(s):
`
`
`
`Team Leader
`
`
`Drug Name(s) and Strength(s):
`
`Teresa McMillan, PharmD
`Division of Medication Error Prevention &Analysis
`Lubna Merchant, M.S., PharmD
`Division of Medication Error Prevention &Analysis
`Gattex (Teduglutide [rDNA origin]) for Injection
`5 mg/vial
`NDA 203441
`
`Application Type/Number:
`NPS Pharmaceuticals
`
`Applicant/sponsor:
`2012-474
`
`OSE RCM #:
`*** This document contains proprietary and confidential information that should not be released to
`the public.***
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 3165159
`
`

`

`
`
`CONTENTS
`INTRODUCTION......................................................................................................................................... 3
`1
`2 METHODS AND DISCUSSION.................................................................................................................. 3
`3 CONCLUSIONS........................................................................................................................................... 3
`4 REFERENCES.............................................................................................................................................. 4
`
`Reference ID: 3165159
`
`
`2
`
`
`

`

`
`
` 1
`
`
`INTRODUCTION
`This re-assessment of the proposed proprietary name, Gattex is written in response to the anticipated
`approval of this NDA within 90 days from the date of this review. DMEPA found the proposed name,
`Gattex , acceptable in OSE Review #2011-4409 dated February 22, 2012.
`
`2 METHODS AND DISCUSSION
`For re-assessments of proposed proprietary names, DMEPA searches a standard set of databases and
`information sources (see section 4) to identify names with orthographic and phonetic similarity to the
`proposed name that have been approved since the previous OSE proprietary name review. For this
`review we used the same search criteria described in OSE Review OSE Review #2011-4409. We
`note that none of the proposed product characteristics were altered. However, 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. The searches of the databases yielded no new names, thought to look or
`sound similar to Gattex and represent a potential source of drug name confusion.
`Additionally, DMEPA searched the USAN stem list to determine if the name contains any USAN
`stems as of the last USAN updates. The Safety Evaluator did not identify any United States Adopted
`Names (USAN) stems in the proposed proprietary name, as of July 24, 2012. The Office of
`Prescription Drug Promotion OPDP re-reviewed the proposed name on July 5, 2012 and had no
`concerns regarding the proposed name from a promotional perspective.
`
`3 CONCLUSIONS
`The re-evaluation of the proposed proprietary name, Gattex, did not identify any vulnerability that
`would result in medication errors with any additional name(s. Thus, DMEPA has no objection to the
`proprietary name, Gattex, for this product at this time.
`DMEPA considers this a final review; however, if approval of the NDA is delayed beyond 90 days
`from the date of this review, the Division of Gastroenterology and Inborn Errors Products should
`notify DMEPA because the proprietary name must be re-reviewed prior to the new approval date.
`If you have further questions or need clarifications, please contact Nitin Patel, OSE project manager,
`at 301-796-5412.
`
`
`Reference ID: 3165159
`
`
`3
`
`
`

`

`
`
`4 REFERENCES
`1.
`OSE Reviews
`OSE Review# 2011-4409; Proprietary Name Review of Gattex; Siahpoushan, M.,
`February 22, 2012.
`
`Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm)
`Drugs@FDA contains most of the drug products approved since 1939. The majority of labels,
`approval letters, reviews, and other information are available for drug products approved from 1998 to
`the present. Drugs@FDA contains official information about FDA approved brand name, generic
`drugs, therapeutic biological products, prescription and over-the-counter human drugs and discontinued
`drugs and “Chemical Type 6” approvals.
`
`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.
`
`Division of Medication Error Prevention and Analysis Proprietary Name Consultation Request
`Compiled list of proposed proprietary names submitted to the Division of Medication Error Prevention
`and Analysis for review. The list is generated on a weekly basis from the Access database/tracking
`system.
`
`2.
`
`3.
`
`4.
`
`
`
`
`
`Reference ID: 3165159
`
`
`4
`
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`TERESA S MCMILLAN
`07/26/2012
`
`LUBNA A MERCHANT
`07/27/2012
`
`Reference ID: 3165159
`
`

`

`
`
`Department of Health and Human Services
`Public Health Service
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Surveillance and Epidemiology
`Office of Medication Error Prevention and Risk Management
`
`Proprietary Name Review
`
`Date:
`
`February 22, 2012
`
`Manizheh Siahpoushan, PharmD, Safety Evaluator
`Reviewer:
`Division of Medication Error Prevention and Analysis
`
`Zachary Oleszczuk, PharmD
`Team Leader:
`Division of Medication Error Prevention and Analysis
`
`Kellie Taylor, PharmD, MPH
`Deputy Director:
`Division of Medication Error Prevention and Analysis
`
`Carol Holquist, RPh
`Division Director:
`Division of Medication Error Prevention and Analysis
`
`Gattex (Teduglutide [rDNA origin]) for Injection
`Drug Name and Strength:
`5 mg/vial
`
`Application Type/Number: NDA 203441
`Applicant:
`NPS Pharmaceuticals
`OSE RCM #:
`2011-4409
`*** This document contains proprietary and confidential information that should not be
`released to the public.***
`
`
`Reference ID: 3090047
`
`
`

`

`
`
`CONTENTS
`
`INTRODUCTION .................................................................................................................... 1 
`1 
`1.1  Regulatory History............................................................................................................. 1
`1.2 Product Information ........................................................................................................... 1 
`2  RESULTS ................................................................................................................................. 2 
`2.1  Promotional Assessment .................................................................................................... 2 
`2.2  Safety Assessment.............................................................................................................. 2 
`3  CONCLUSIONS....................................................................................................................... 5 
`3.1  Comments to the Applicant................................................................................................ 5 
`4  REFERENCES.......................................................................................................................... 6 
`APPENDICES................................................................................................................................. 8 
`
`
`
`
`
`
`Reference ID: 3090047
`
`
`

`

`
`
`1
`INTRODUCTION
`This review evaluates the proposed proprietary name, Gattex, from a safety and
`promotional perspective. The sources and methods used to evaluate the proposed name
`are outlined in the reference section and Appendix A respectively.
`
`1.1
`REGULATORY HISTORY
`NPS Pharmaceuticals submitted a request for Proprietary Name Review of Gattex
`(Teduglutide [rDNA origin]) for Injection, for NDA 203441, on November 30, 2011.
`DMEPA reviewed the proposed proprietary name, Gattex in the IND phase (IND
`058213) in OSE Review #2009-2001, dated March 19, 2010 and found the name
`acceptable.
`
`1.2
`PRODUCT INFORMATION
`The following product information is provided in the November 30, 2011 proprietary
`name submission.
` Active Ingredient: Teduglutide
`
`Indication of Use: Treatment of adult patients with Short Bowel Syndrome (SBS)
`to improve intestinal absorption of fluid and nutrients.
` Route of administration: Subcutaneous
` Dosage form: Powder for Injection
` Strength: 5 mg per vial
` Dose and Frequency of Administration: 0.05 mg/kg administered once daily,
`subcutaneously to alternating sites between one fo the four quadrants of the
`abdomen, or into alternating thighs or alternating arms.
` How Supplied: Supplied in a sterile, single-use, 3 mL vial containing 5 mg of
`Gattex as a white lyophilized powder to be reconstituted with 0.5 mL Sterile
`Water for Injection supplied in disposable pre-filled syringes. Available in a
`30-vial kit and a one-vial kit.
`
`30-vial Kit:
`
`*Thirty single-use vials of drug
`
`*Thirty disposable prefilled syringes containing Sterile Water for
`
` Injection USP for reconstitution with 30 separate needles to attach to the
`
` syringes.
`
`*Thirty sterile disposable 1 mL syringes with needle for dosing
`
`*Sixty
` alcohol swabs
`One-vial Kit:
`
`*One single-use vial of drug
`
`*One disposable prefilled syringe containing Sterile Water for Injection
`
` USP for reconstitution with a separate needle to attach to the syringes.
`
`
`
`
`
`
`Reference ID: 3090047
`
`
`1
`
`(b) (4)
`
`

`

`*One sterile disposable 1 mL syringe with needle for dosing
`*One alcohol swab
`
`0
`
`Storage: Prior to dispensing: Store at 2°C to 8°C (36°F to 46°F), Do not freeze.
`(m4) “Store at
`
`room temperature up to 25°C (77°F). Do not freeze.
`
`0 Container and Closure systems: The container closure system for teduglutide for
`injection is comprised of 3-mL, Type I glass tubing vials
`(m4)
`crimped aluminum seals
`(m4), flip-off buttons. The Sterile Water for
`m4)
`fitted with
`Injection is supplied in prefilled, single-use, USP Type I glass syringes
`0am)
`The Sterile Water for Injection, USP prefilled syringe is
`(M4)
`
`supplied
`
`2 RESULTS
`
`The following sections provide the information obtained and considered in the evaluation
`of the proposed proprietary name.
`
`2.1
`
`PROMOTIONAL ASSESSMENT
`
`The Office of Prescription Drug Promotion (OPDP) determined the proposed name is
`acceptable from a promotional perspective. DMEPA and the Division of
`Gastroenterology and Inbom Errors Products (DGIEP) concurred with the findings of
`OPDP’s promotional assessment of the proposed name.
`
`2.2
`
`SAFETY ASSESSMENT
`
`The following aspects of the name were considered in the overall evaluation.
`
`2.2.1 United States Adopted Names (USAN) SEARCH
`
`On December 7, 2011 the United States Adopted Name (USAN) stem search, identified
`that a USAN stem is not present in the proposed proprietary name.
`
`2.2.2 Components ofthe Proposed Proprietary Name
`
`The Applicant did not propose the intended meaning or the derivation of the proposed
`proprietary name.
`
`This proprietary name is comprised of a single word that does not contain any
`components (i.e. a modifier, route of administration, dosage form, etc.) that are
`misleading or can contribute to medication error.
`
`2.2.3 FDA Name Simulation Studies
`
`Twenty-six practitioners participated in DMEPA’s prescription studies. The
`interpretations did not overlap with or appear or sound similar to any currently marketed
`products. Fifteen participants interpreted the name correctly as Gattex (11 participants
`from the inpatient and 4 participants from the outpatient prescription studies). Four
`
`Reference ID: 3090047
`
`2
`
`

`

`participants from the voice prescription studies omitted one of the two letter ‘t’s from the
`name (i.e. Gatex). Two participants from the outpatient prescription studies interpreted
`letter ‘6’ as letter string ‘Er’. See Appendix C for the complete listing of interpretations
`from the verbal and written prescription studies.
`
`2.2.4 Comments from Other Review Disciplines
`
`In response to the OSE, December 9, 2011 e-mail, the Division of Gastroenterlogy and
`Inbom Errors Products (DGIEP) did not forward any comments or concerns relating to
`the proposed name at the initial phase of the proprietary name review.
`
`2.2.5 Failure Mode and Effects Analysis ofSimilar Names
`
`Appendix B lists possible orthographic and phonetic misinterpretations of the letters
`appearing in the proposed proprietary name, Gattex. Table 1 lists the names with
`orthographic, phonetic, or spelling similarity to the proposed proprietary name, Gattex,
`identified by the primary reviewer (PR) and the Expert Panel Discussion GEPD).
`Table 1 also includes the names identified by
`0M) not identified by DMEPA
`and require further evaluation.
`
`Table 1: Collective List of Potentially Similar Names (DMEPA, EPD, and
`
`W"
`
`Look Similar
`
`Name
`
`Source
`
`Name
`
`Source
`
`Name
`
`Source
`
`Adipex
`
`Algitex
`
`Antistax
`
`Antrex
`
`Atarax
`
`“M" Gatimax
`
`Gatol
`
`Gel-Kam
`
`Gerimal
`
`Gets-it
`
`EPD
`
`EPD
`
`EPD
`
`EPD
`
`EPD
`
`Satric
`
`EPD
`
`SetonET
`
`EPD
`
`Sitrex PD
`
`EPD
`
`Solex
`
`EPD
`
`Gallium
`
`EPD
`
`Attenuvax
`
`Gildess Fem PR
`
`Galzin
`
`Gilenya
`
`Giltuss
`
`Gleevec
`
`Goflex
`
`Halotex
`
`Kantrex
`
`EPD
`
`EPD
`
`EPD
`
`EPD
`
`Gamunex
`
`Sotret
`
`(51(4) Subutex
`
`Sulla
`
`Sulten—lO
`
`(m4) Sultrin
`
`EPD
`
`EPD
`
`EPD
`
`EPD
`
`Axert
`
`Catex
`
`Catrix
`
`Cetraxal
`
`Coldex A
`
`Cotabax
`
`383
`
`EPD
`
`EPD
`
`EPD
`
`EPD
`
`EPD
`
`EPD
`
`EPD
`
`This document contains proprietary and confidential information that should not be released to the
`public.
`
`Reference ID: 3090047
`
`3
`
`

`

`Table 1 Continued: Collective List of Potentially Similar Names (DMEPA, EPD, and,
`00(4)
`
`Look Similar
`
`Name
`
`Source
`
`Name
`
`Source
`(hm)
`
`Name
`
`Source
`
`Crantex
`
`EPD
`
`Lasix
`
`Sutent
`
`EPD
`
`00(4)
`
`00(4)
`
`(m4)
`
`Qutenza
`Ranexa
`
`EPD
`
`EPD
`
`Testrex
`
`(m4) Trudexa
`Zostex
`
`EPD
`
`00(4)
`
`EPD
`Zyprexa
`Salex
`EPD _-
`Salflex
`Sound Similar
`
`Dexamethasone
`
`Entex
`Ganite
`
`Ganitrisin
`Gatifloxacin
`
`Capex
`
`leek
`
`EPD
`
`Chantrx
`
`EPD _D-_D_
`
`Ganvex
`
`Gas-X
`
`EPD
`
`Gattex
`
`EPD
`
`Guiatex H
`
`EPD
`
`Look and Sound Similar
`
`Gatten
`
`Gatter
`
`EPD
`
`EPD
`
`SR and
`
`Guiatex H
`PE
`
`Gattexo
`
`EPD
`
`Guiatuss
`
`EPD
`
`Guiadex DM EPD
`
`PD
`
`and Guiadex
`
`Our analysis of the 65 names contained in Table 1 considered the information obtained in
`the previous sections along with their product characteristics. We determined 65 names
`will not pose a risk for confusion as described in Appendix D through E.
`
`2.2. 7 Communication ofDMEPA ’5 Final Decision to Other Disciplines
`
`DMEPA communicated our fmdings to the Division of Gastroenterology and Inborn
`Errors Products via e—mail on January 10, 2012. At that time we also requested
`additional information or concerns that could inform our review. As of
`
`February 22, 2012, the Division of Gastroenterology and Inborn Errors Products did not
`forward any additional concerns with the proposed proprietary name, Gattex.
`
`Reference ID: 3090047
`
`4
`
`

`

`
`
`3 CONCLUSIONS
`The proposed proprietary name is acceptable from both a promotional and safety
`perspective.
`If you have further questions or need clarifications, please contact Nitin Patel, OSE
`project manager, at 301-796-5412.
`
`3.1 COMMENTS TO THE APPLICANT
`We have completed our review of the proposed proprietary name, Gattex, and have
`concluded that this name is acceptable. However, if any of the proposed product
`characteristics as stated in your November 30, 2011 submission are altered, DMEPA
`rescinds this finding and the name must be resubmitted for review. Additionally, this
`proprietary name must be re-evaluated 90 days prior to the approval of the application.
`The conclusions upon re-review are subject to change.
`
`Reference ID: 3090047
`
`
`5
`
`

`

`
`
` 4
`
` REFERENCES
`
`1. Micromedex Integrated Index (http://csi.micromedex.com)
`Micromedex contains a variety of databases covering pharmacology, therapeutics,
`toxicology and diagnostics.
`
`2. Phonetic and Orthographic Computer Analysis (POCA)
`POCA is a database which was created for the Division of Medication Error
`Prevention and Analysis, FDA. As part of the name similarity assessment, proposed
`names are evaluated via a phonetic/orthographic algorithm. The proposed proprietary
`name is converted into its phonemic representation before it runs through the phonetic
`algorithm. Likewise, an orthographic algorithm exists which operates in a similar
`fashion.
`
`3. Drug Facts and Comparisons, online version, St. Louis, MO
`(http://factsandcomparisons.com)
`Drug Facts and Comparisons is a compendium organized by therapeutic course; it
`contains monographs on prescription and OTC drugs, with charts comparing similar
`products. This database also lists the orphan drugs.
`
`4. FDA Document Archiving, Reporting & Regulatory Tracking System [DARRTS]
`DARRTS is a government database used to organize Applicant and Sponsor
`submissions as well as to store and organize assignments, reviews, and
`communications from the review divisions.
`
`5. Division of Medication Errors Prevention and Analysis proprietary name
`consultation requests
`This is a list of proposed and pending names that is generated by the Division of
`Medication Error Prevention and Analysis from the Access database/tracking system.
`
`6. Drugs@FDA (http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm)
`Drugs@FDA contains most of the drug products approved since 1939. The majority of
`labels, approval letters, reviews, and other information are available for drug products
`approved from 1998 to the present. Drugs@FDA contains official information about FDA
`approved brand name, generic drugs, therapeutic biological products, prescription and over-
`the-counter human drugs and discontinued drugs and “Chemical Type 6” approvals.
`7. U.S. Patent and Trademark Office (http://www.uspto.gov)
`USPTO provides information regarding patent and trademarks.
`
`8. Clinical Pharmacology Online (www.clinicalpharmacology-ip.com)
`Clinical Pharmacology contains full monographs for the most common drugs in
`clinical use, plus mini monographs covering investigational, less common,
`
`Reference ID: 3090047
`
`
`6
`
`

`

`
`
`combination, nutraceutical and nutritional products. It also provides a keyword search
`engine.
`
`9. Data provided by Thomson & Thomson’s SAEGIS ™ Online Service, available at
`(www.thomson-thomson.com)
`The Pharma In-Use Search database contains over 400,000 unique pharmaceutical
`trademarks and trade names that are used in about 50 countries worldwide. The data
`is provided under license by IMS HEALTH.
`
`10. Natural Medicines Comprehensive Databases (www.naturaldatabase.com)
`Natural Medicines contains up-to-date clinical data on the natural medicines, herbal
`medicines, and dietary supplements used in the western world.
`
`11. Access Medicine (www.accessmedicine.com)
`Access Medicine® from McGraw-Hill contains full-text information from
`approximately 60 titles; it includes tables and references. Among the titles are:
`Harrison’s Principles of Internal Medicine, Basic & Clinical Pharmacology, and
`Goodman and Gilman’s The Pharmacologic Basis of Therapeutics.
`
`12. USAN Stems (http://www.ama-assn.org/ama/pub/about-ama/our-people/coalitions-
`consortiums/united-states-adopted-names-council/naming-guidelines/approved-
`stems.shtml)
`USAN Stems List contains all the recognized USAN stems.
`
`13. Red Book Pharmacy’s Fundamental Reference
`Red Book contains prices and product information for prescription, over-the-counter
`drugs, medical devices, and accessories.
`
`14. Lexi-Comp (www.lexi.com)
`Lexi-Comp is a web-based searchable version of the Drug Information Handbook.
`
`15. Medical Abbreviations Book
`Medical Abbreviations Book contains commonly used medical abbreviations and
`their definitions.
`
`16. CVS/Pharmacy (www.CVS.com)
`This database contains commonly used over the counter products not usually
`identified in other databases.
`
`17. Walgreens (www.walgreens.com)
`This database contains commonly used over the counter products not usually
`identified in other databases.
`
`Reference ID: 3090047
`
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`18. Rx List (www.rxlist.com)
`RxList is an online medical resource dedicated to offering detailed and current
`pharmaceutical information on brand and generic drugs.
`
`19. Dogpile (www.dogpile.com)
`Dogpile is a Metasearch engine that searches multiple search engines including
`Google, Yahoo! and Bing, and returns the most relevant results to the search.
`
`APPENDICES
`Appendix A
`FDA’s Proprietary Name Risk Assessment considers the promotional and safety aspects
`of a proposed proprietary name. The promotional review of the proposed name is
`conducted by OPDP. OPDP evaluates proposed proprietary names to determine if they
`are overly fanciful, so as to misleadingly imply unique effectiveness or composition, as
`well as to assess whether they contribute to overstatement of product efficacy,
`minimization of risk, broadening of product indications, or making of unsubstantiated
`superiority claims. OPDP provides their opinion to DMEPA for consideration in the
`overall acceptability of the proposed proprietary name.
`The safety assessment is conducted by DMEPA. DMEPA staff search a standard set of
`databases and information sources to identify names that are similar in pronunciation,
`spelling, and orthographically similar when scripted to the proposed proprietary name.
`Additionally, we consider inclusion of USAN stems or other characteristics that when
`incorporated into a proprietary name may cause or contribute to medication errors (i.e.,
`dosing interval, dosage form/route of administration, medical or product name
`abbreviations, names that include or suggest the composition of the drug product, etc.).
`DMEPA defines a medication error as any preventable event that may cause or lead to
`inappropriate medication use or patient harm while the medication is in the control of the
`health care professional, patient, or consumer. 1
`Following the preliminary screening of the proposed proprietary name, DMEPA gathers
`to discuss their professional opinions on the safety of the proposed proprietary name.
`This meeting is commonly referred to the Center for Drug Evaluation and Research
`(CDER) Expert Panel discussion. DMEPA also considers other aspects of the name that
`may be misleading from a safety perspective. DMEPA staff conducts a prescription
`simulation studies using FDA health care professionals. When provided, DMEPA
`considers external proprietary name studies conducted by or for the Applicant/Sponsor
`and incorporates the findings of these studies into the overall risk assessment.
`The DMEPA primary reviewer assigned to evaluate the proposed proprietary name is
`responsible for considering the collective findings, and provides an overall risk
`assessment of the proposed proprietary name. DMEPA bases the overall risk assessment
`on the findings of a Failure Mode and Effects Analysis (FMEA) of the proprietary name
`
`
`1 National Coordinating Council for Medication Error Reporting and Prevention.
`http://www nccmerp.org/aboutMedErrors html. Last accessed 10/11/2007.
`
`Reference ID: 3090047
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`and misleading nature of the proposed proprietary name with a focus on the avoidance of
`medication errors.
`DMEPA uses the clinical expertise of its staff to anticipate the conditions of the clinical
`setting where the product is likely to be used based on the characteristics of the proposed
`product. DMEPA considers the product characteristics associated with the proposed
`product throughout the risk assessment because the product characteristics of the
`proposed may provide a context for communication of the drug name and ultimately
`determine the use of the product in the usual clinical practice setting.
`Typical product characteristics considered when identifying drug names that could
`potentially be confused with the proposed proprietary name include, but are not limited
`to; established name of the proposed product, proposed indication of use, dosage form,
`route of administration, strength, unit of measure, dosage units, recommended dose,
`typical quantity or volume, frequency of administration, product packaging, storage
`conditions, patient population, and prescriber population. DMEPA considers how these
`product characteristics may or may not be present in communicating a product name
`throughout the medication use system. Because drug name confusion can occur at any
`point in the medication use process, DMEPA considers the potential for confusion
`throughout the entire U.S. medication use process, including drug procurement,
`prescribing and ordering, dispensing, administration, and monitoring the impact of the
`medication.2
`The DMEPA considers the spelling of the name, pronunciation of the name when spoken, and
`appearance of the name when scripted. DMEPA compares the proposed proprietary name
`with the proprietary and established name of existing and proposed drug products and names
`currently under review at the FDA. DMEPA compares the pronunciation of the proposed
`proprietary name with the pronunciation of other drug names because verbal communication
`of medication names is common in clinical settings. DMEPA examines the phonetic
`similarity using patterns of speech. If provided, DMEPA will consider the Sponsor’s intended
`pronunciation of the proprietary name. However, DMEPA also considers a variety of
`pronunciations that could occur in the English language because the Sponsor has little control
`over how the name will be spoken in clinical practice. The orthographic appearance of the
`proposed name is evaluated using a number of different handwriting samples. DMEPA
`applies expertise gained from root-cause analysis of postmarketing medication errors to
`identify sources of ambiguity within the name that could be introduced when scripting
`(e.g.,“T” may look like “F,” lower case ‘a’ looks like a lower case ‘u,’ etc). Additionally,
`other orthographic attributes that determine the overall appearance of the drug name when
`scripted (see Table 1 below for details).
`
`
`
`
`
`
`2 Institute of Medicine. Preventing Medication Errors. The Nationa