CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`202236Orig1s000
`
`
`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:
`
`
`
`April 2, 2011
`
` Yelena Maslov, Pharm.D., Acting team Leader
`Reviewer:
`Division of Medication Error Prevention and Analysis
`
`
` Dymista (Azelastine Hydrochloride and Fluticasone Propionate)
`Drug Name and Strength:
` Nasal Spray, 137 mcg/50 mcg per actuation
`Application Type/Number:
`
`NDA 202236
`Applicant/sponsor:
`
`Meda Pharmaceuticals
`OSE RCM #:
`
`2011-3906
`*** This document contains proprietary and confidential information that should not be released to
`the public.***
`
`Reference ID: 3110637
`
`1
`
`

`

`CONTENTS
`
`INTRODUCTION .......................................................................................................................................... 3
`1
`2 METHODS AND DISCUSSION ................................................................................................................... 3
`3 CONCLUSIONS............................................................................................................................................. 3
`3.1 Comments to the Applicant.....................................................................Error! Bookmark not defined.
`4 REFERENCES ............................................................................................................................................... 4
`
`Reference ID: 3110637
`
`2
`
`

`

`1 INTRODUCTION
`This re-assessment of the proposed proprietary name, Dymista, 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, Dymista, acceptable in OSE Review #2011-1448 dated July 14, 2011.
`
`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 #2011-1448. Since none of the
`proposed product characteristics were altered we did not re-evaluate previous names of concern. The
`searches of the databases yielded one new name
` thought to look similar to Dymista and
`represent a potential source of drug name confusion. Failure mode and effects analysis was applied to
`determine if the proposed proprietary name could potentially be confused with
` and lead to
`medication errors. This analysis determined that the name similarity between Dymista and the
`identified names was unlikely to result in medication error for the reasons presented in Appendix A.
`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 April 2, 2011. OPDP re-reviewed the
`proposed name on November 3, 2011, and had no concerns regarding the proposed name from a
`promotional perspective.
`
`3 CONCLUSIONS
`The re-evaluation of the proposed proprietary name, Dymista, did not identify any vulnerabilities that
`would result in medication errors with any additional name(s) noted in this review. Thus, DMEPA has
`no objection to the proprietary name, Dymista, 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 Pulmonary and Rheumatology 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 Nichelle Rashid, OSE project
`manager, at 301-796-3904.
`
`
`*** This document contains proprietary information that should not be released to the public
`
`Reference ID: 3110637
`
`3
`
`(b) (4)
`
`(b) (4)
`
`

`

`4 REFERENCES
`1.
`Maslov, Yelena. Proprietary Name Review for Dymista. OSE Review #2011-1488
`
`2.
`
`3.
`
`4.
`
`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.
`
`Reference ID: 3110637
`
`4
`
`

`

`Appendix A: Failure Mode and Effect Analysis Table
`
`Causes (could be multiple)
`
`Prevention of Failure Mode
`
`m This document contains proprietary information that should not be released to the public
`
`Reference ID: 3110637
`
`5
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`YELENA L MASLOV
`04/02/2012
`
`Reference ID: 3110637
`
`

`

`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:
`
`July 13, 2011
`
`Yelena Maslov, Pharm.D., Safety Evaluator
`Reviewer:
`Division of Medication Error Prevention and Analysis
`
`Zachary Oleszczuk, Pharm.D., Team Leader
`Team Leader:
`Division of Medication Error Prevention and Analysis
`
`Carol Holquist, R.Ph., Director
`Division Director:
`Division of Medication Error Prevention and Analysis
`
`Dymista (Azelastine Hydrochloride and Fluticasone Propionate)
`Drug Name and Strength:
` Nasal Spray, 137 mcg/50 mcg per actuation
`Application Type/Number: NDA 202236
`Applicant/sponsor:
`Meda Pharmaceuticals
`OSE RCM #:
`2011-1448
`*** This document contains proprietary and confidential information that should not be released to
`the public.***
`
`Reference ID: 2973338
`
`

`

`CONTENTS
`
`INTRODUCTION .......................................................................................................................................... 3
`1
`2 METHODS AND DISCUSSION ................................................................................................................... 3
`3 CONCLUSIONS............................................................................................................................................. 3
`4 REFERENCES ............................................................................................................................................... 4
`
`Reference ID: 2973338
`
`2
`
`

`

`1 INTRODUCTION
`This review evaluates the proposed proprietary name, Dymista, for April 29, 2011 submission of the
`New Drug Application (NDA 202236). DMEPA found the proposed name, Dymista, acceptable in
`the IND 077363 in OSE Review #2010-2403, dated April 15, 2011. Since the IND review was
`completed only three months ago, DMEPA completed an abbreviated name review.
`
`2 METHODS AND DISCUSSION
`2.1 PROMOTIONAL ASSESSMENT
`DDMAC re-evaluated the proposed proprietary name, Dymista, on May 19, 2011, and found it
`acceptable from the promotional perspective. DMEPA and the Division of Pulmonary, Allergy and
`Rheumatology Products (DPARP) concur with DDMAC’s assessment.
`2.2 SAFETY ASSESSMENT
`DMEPA searched a standard set of databases and information sources (see Section 4) to identify
`names with orthographic and phonetic similarity to the proposed name since the previous OSE
`proprietary name review. For this review we used the same search criteria described in OSE Review
`#2010-2403. Since none of the proposed product characteristics were altered, we did not re-evaluate
`previous names of concern. The searches of the databases yielded eight new names (Ayr Saline Mist,
`Glyoxide, Oxyfast, Duohist DH, Dyna-hex, Dynapen, Symlin, and Gymiso), thought to look or sound
`similar to Dymista and represent a potential source of drug name confusion.
`DMEPA bases the overall risk assessment on the findings of a Failure Mode and Effects Analysis
`(FMEA) of the proposed proprietary name, and focuses on the avoidance of medication errors.
`Failure mode and effects analysis was applied to determine if the proposed proprietary name could
`potentially be confused with any of the eight names and lead to medication errors. This analysis
`determined that the name similarity between Dymista and the identified names was unlikely to result
`in medication error for the reasons presented in Appendices A and B.
`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 June 14, 2011.
`
`3 CONCLUSIONS
`The re-evaluation of the proposed proprietary name, Dymista, did not identify any vulnerabilities that
`would result in medication errors with the additional name noted in this review. Thus, DMEPA has no
`objection to the proprietary name, Dymista, for this product at this time. However, if any of the
`proposed product characteristics as stated in this review are altered, DMEPA rescinds this finding and
`the name must be resubmitted for review. The conclusions upon re-review are subject to change.
`Additionally, the name, Dymista, must be re-reviewed 90 days prior to the NDA approval.
`If you have further questions or need clarifications, please contact Nichelle Rashid OSE project
`manager, at 301-796-3904.
`
`Reference ID: 2973338
`
`3
`
`

`

`4. REFERENCES
`1. Crandall, Anne. OSE Review #2010-2403, Dymista Proprietary Name Review, April 15, 2011.
`
`2. Micromedex Integrated Index (http://csi.micromedex.com)
`Micromedex contains a variety of databases covering pharmacology, therapeutics, toxicology and
`diagnostics.
`
`3. 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.
`
`4. 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.
`
`5. 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.
`
`6. 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.
`
`7. 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.
`
`8. Electronic online version of the FDA Orange Book (http://www.fda.gov/cder/ob/default.htm)
`The FDA Orange Book provides a compilation of approved drug products with therapeutic
`equivalence evaluations.
`
`9. U.S. Patent and Trademark Office (http://www.uspto.gov)
`USPTO provides information regarding patent and trademarks.
`
`Reference ID: 2973338
`
`4
`
`

`

`10. 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, combination, nutraceutical and
`nutritional products. It also provides a keyword search engine.
`
`11. 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.
`
`12. 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.
`
`13. Access Medicine Database (http://www.accessmedicine.com/drugs.aspx)
`Access Medicine contains full-text information from approximately 60 medical titles: it includes
`tables and references. Among the database titles are: Goodman and Gilman’s The
`Pharmacological Basis of Therapeutics, Current Medical Diagnosis and Treatment, Tintinalli’s
`Emergency Medicine, and Hurst’s the Heart.
`
`14. 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.
`
`15. Red Book Pharmacy’s Fundamental Reference
`Red Book contains prices and product information for prescription, over-the-counter drugs,
`medical devices, and accessories.
`
`16. Lexi-Comp (www.lexi.com)
`Lexi-Comp is a web-based searchable version of the Drug Information Handbook.
`
`17. Medical Abbreviations Book
`Medical Abbreviations Book contains commonly used medical abbreviations and their definitions.
`18. LabelDataPlus Database (http://www.labeldataplus.com/index.php?ns=1
`LabelDataPlus database covers a total of 36773 drug labels. This includes Human prescription
`drug labels as well as Active Pharmaceutical Ingredients (APIs), OTC (Application and
`Monograph) drugs, Homeopathic drugs, Unapproved drugs, and Veterinary drugs.
`
`Reference ID: 2973338
`
`5
`
`

`

`Appendix A: Proprietary names not likely to be confused or not used in usual practice settings for
`the reasons described.
`
`Product Name
`
`Similarity to
`Edurant
`
`Failure preventions
`
`
`
`Ayr Saline Mist
`(Sodium Chloride)
`
`Duohist DH
`(Chlorpheniramine.
`Dihydrocodeine. Phenylephrine)
`
`Looks alike
`
`Lacks sufficient orthographic similarity
`
`The product is discontinued without generic
`equivalent
`
`Gymiso
`(Miso .rostol)
`
`Looks alike and
`sounds alike
`
`Foreign product available in France
`
`Appendix B: Failure Mode and Effect Analysis Table
`
`Strength(s):
`137 meg/50 mcg per actuation
`
`Usual dose:
`One spray into each nostril twice
`daily
`
`Causes (could be multiple)
`
`Prevention of Failure Mode
`
`Orthogaphic
`Both names share the letter ‘y’.
`Additionally. the letters ‘D‘ and ‘t' in
`Dymista may appear similar to the letters
`‘G’ and ‘d’ in Gly-oxide when scripted.
`
`Orthographic
`The name Dymista contains 2 upstrokes
`vs. the name Gly-oxide contains 3
`upstrokes. Additionally, the letter string
`‘mis’ in Dymista lacks orthographic
`similarity to the letter string ‘oxi‘ in
`Gly—oxide when scripted.
`
`Dosage form
`Nasal spray vs. solution or gel
`
`Usual Dose
`
`One spar to each nostril vs. Apply
`several drops (solution) or apply a thin
`layer (gel)
`
`Frequency of Administration
`Twice daily vs. five times daily (four
`times per day after meals and at
`bedtime).
`
`
`
`Usual Dose
`Strength
`Apply several drops
`(solution) or apply a thin Both products are available in a single
`layer (gel) to affected
`strength: thus. the strength may be omitted
`area of the mouth four
`times per day after meals
`and at bedtime.
`
`Proposed name:
`Dymista
`(Azelastiue
`Hydrochloride and
`Fluticasoue Propionate)
`Nasal S ra
`
`Failure Mode:
`Incorrect Product
`Ordered/
`
`Selected/Dispensed or
`Administered because
`of Name confusion
`
`Gly-oxide
`(Carbamide Peroxide)
`Dental Gel. 10%
`Dental Solution. 10%
`
`Reference ID: 2973338
`
`

`

`Oxyfast
`(Oxycodone) Oral
`Solution,
`600 mg/30 mL
`(20 mg/mL)
`
`Usual Dose
`15 mg to 20 mg orally
`every 6 hours as needed
`for pain
`
`Orthographic
`Both names share the letter ‘y’ and the
`letter string ‘st’. Additionally, the letter ‘D’
`may appear similar to the letter ‘O’ when
`scripted.
`
`Strength
`Both products are available in a single
`strength; thus, the strength may be omitted
`
`Orthographic
`Both names share the letter string ‘Dy-’.
`Additionally, the letter string ‘mi’ and the
`letter ‘t’ in Dymista may appear similar to
`the letter string ‘na’ and the letter ‘h’ in
`Dyna-hex when scripted.
`
`Strength
`Both products are available in a single
`strength; thus, the strength may be omitted
`
`Dyna-hex
`(Chlorhexidine
`Gluconate) Topical
`Solution, 4%
`
`Usual Dose
`Surgical Scrub: apply 5
`mL and scrub for 3
`minutes using a wet
`brush.
`Pre-operative patient
`preparation: apply
`liberally to surgical site
`and swab for 2 minutes
`or more.
`
`Orthographic
`The name Dymista contains 1 down
`stroke vs. the name Oxyfast contains 2
`down strokes. Additionally, the letter
`string ‘mi’ in Dymista lacks
`orthographic similarity to the letter
`string ‘fa’ in Oxyfast when scripted.
`Also, although both names share the
`letter ‘y’ and the letter string ‘st’, the
`letters are located in different positions
`of the names.
`
`Usual Dose
`One spray to each nostril vs. 15 mg to
`20 mg
`
`Frequency of Administration
`Twice daily vs. every 6 hours as needed.
`
`Usual Dose
`One spray to each nostril vs. apply 5 mL
`and scrub for 3 minutes or apply
`liberally to surgical site and swab for 2
`minutes or more
`
`Frequency of Administration
`Twice daily vs. once
`
`Reference ID: 2973338
`
`7
`
`

`

`Orthographic
`Both names share the letter string ‘Dy-’.
`Additionally, the letter string ‘mi’ and the
`letter ‘a’ in Dymista may appear similar to
`the letter string ‘na’ in Dynapen and the
`letter ‘n’ when scripted.
`
`Dynapen*
`(Dicloxacillin) Capsules,
`250 mg and 500 mg
`Although the proprietary
`name is discontinued,
`multiple generic products
`are still on the market.
`
`Usual Dose
`250 mg to 500 mg orally
`every 6 hours.
`
`Symlin
`(Pramlintide Acetate)
`Injection, 0.6 mg/mL
`and 1 mg/mL
`
`Usual Dose
`15 mcg to 60 mcg
`subcutaneously prior to
`each meal
`
`Orthographic
`Both names contain 1 down stroke and 2
`upstrokes. Additionally, the letter string
`‘Dym’ and the letter ‘a’ may appear similar
`to the letter string ‘Sym’ and the letter ‘n’
`when scripted.
`
`Orthographic
`The name Dymista contains 1 down
`stroke and 2 upstrokes vs. the name
`Dynapen contains 2 down strokes and 1
`upstroke. Additionally, the letter string
`‘st’ in Dymista lacks orthographic
`similarity to the letter string ‘pe’ in
`Dynapen when scripted.
`
`Strength
`Although Dymista can be dosed at
`50 mcg of Fluticasone Proprionate and
`Dynapen at 500 mg, the confusion is
`unlikely because Dymista also contains
`Azelastine Hydrochloride as the active
`ingredient in the product and the
`strength of the first ingredient is rarely
`omitted.
`
`Frequency of Administration
`Twice daily vs. every 6 hours.
`
`Orthographic
`The name Dymista appears longer than
`the name Symlin, because it contains
`more letters (7 letters vs. 6 letters) and
`the extra letter is the wider letter ‘s’.
`Additionally, the upstroke ‘t’ in Dymista
`is in different position than the upstroke
`‘l’ in Symlin.
`
`Strength
`Single strength (137 mcg/50 mcg per
`actuation) vs. 0.6 mg/mL and 1 mg/mL
`
`Route of Administration
`Nasal vs. subcutaneous.
`
`Usual Dose
`One spray to each nostril vs. 15 mcg to
`60 mcg subcutaneously
`
`Reference ID: 2973338
`
`8
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`YELENA L MASLOV
`07/13/2011
`
`ZACHARY A OLESZCZUK
`07/13/2011
`
`CAROL A HOLQUIST
`07/14/2011
`
`Reference ID: 2973338
`
`