CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`202270Orig1s000
`
`
`PROPRIETARY NAME REVIEW(S)
`
`
`
`
`
`

`

`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`
`
`
`
`
`NDA 202270
`
`PROPRIETARY NAME REQUEST
`CONDITIONALLY ACCEPTABLE
`
`Richard J. Swanson, Ph.D.
`Senior Director, Worldwide Regulatory Affairs
`
`
`Merck Sharp & Dohme Corp.
`P.O. Box 1000, UG2C-50
`North Wales, PA 19454-1099
`
`Attention:
`
`
`Dear Dr. Swanson:
`
`Please refer to your New Drug Application (NDA) dated September 23, 2010, received
`September 23, 2010, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
`Act for Sitagliptin and Metformin Extended-release Tablets, 50 mg/500 mg, 50 mg/1000 mg, and
`100 mg/1000 mg.
`
`We also reference your Class 2 resubmission to your New Drug Application (NDA) dated
`August 3, 2011, and received August 3, 2011.
`
`We also reference your original March 25, 2011, correspondence, received March 25, 2011,
`requesting review of your proposed proprietary name Janumet XR. Additionally, we also
`reference your August 16, 2011, correspondence, received August 16, 2011, requesting review of
`your proposed proprietary name, Janumet XR. We have completed our review of the proposed
`proprietary name, Janumet XR and have concluded that it is acceptable.
`
`If any of the proposed product characteristics as stated in your August 16, 2011, submission are
`altered prior to approval of the marketing application, the proprietary name should be
`resubmitted for review.
`
`If you have any questions regarding the contents of this letter or any other aspects of the
`proprietary name review process, contact Margarita Tossa, Safety Regulatory Project Manager in
`the Office of Surveillance and Epidemiology, at (301) 796-4053. For any other information
`regarding this application contact the Office of New Drugs (OND) Regulatory Project Manager,
`Raymond S. Chiang at (301) 796-1940
`
`
`
`
`Reference ID: 3040034
`
`
`
`Sincerely,
`{See appended electronic signature page}
`
`
`
`
`
`
`Carol Holquist, RPh
`Director
`Division of Medication Error Prevention and Analysis
`Office of Medication Error Prevention and Risk Management
`Office of Surveillance and Epidemiology
`Center for Drug Evaluation and Research
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`CAROL A HOLQUIST
`11/04/2011
`
`Reference ID: 3040034
`
`

`

`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
`
`November 1, 2011
`
`Richard Abate, RPh, MS, Safety Evaluator
`Division of Medication Error Prevention and Analysis
`Carlos Mena-Grillasca, RPh, Team Leader
`Division of Medication Error Prevention and Analysis
`Carol Holquist, RPh, Director
`Division of Medication Error Prevention and Analysis
`Janumet XR (Sitagliptin and Metformin Extended-release) Tablets,
`50 mg/500 mg, 50 mg/1000 mg, and 100 mg/1000 mg
`
`NDA 202270
`Merck, Sharpe, and Dohme, Corp
`2011-3134
`
`Date:
`
`Reviewer(s):
`
`Team Leader
`
`Division Director
`
`Drug Name(s):
`
`
`
`
`
`Application Type/Number:
`Applicant:
`OSE RCM #:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1
`
`Reference ID: 3037501
`
`
`

`

`1
`
`CONTENTS
`INTRODUCTION......................................................................................................................................... 3
`1.1
`Regulatory History............................................................................................................................... 3
`2 METHODS AND DISCUSSION.................................................................................................................. 3
`3 CONCLUSIONS........................................................................................................................................... 3
`3.1
`Comments to the Applicant.................................................................................................................. 4
`4 REFERENCES.............................................................................................................................................. 5
`
`Reference ID: 3037501
`
`
`2
`
`

`

` 1
`
`
`INTRODUCTION
`This re-assessment of the proposed proprietary name, Janumet XR, is written in response to the
`Request for Proprietary Name Review submitted August 18, 2011 and to the anticipated approval of
`this NDA within 90 days from the date of this review.
`
`1.1 REGULATORY HISTORY
`The Division of Medication Error Prevention and Analysis (DMEPA) found the proposed name,
`Janumet XR, acceptable in OSE Review 2011-1111 dated June 16, 2011. However, this application
`received a Complete Response on July 22, 2011 due to deficiencies identified during a facilities
`inspection. The Applicant submitted a response to the CR letter August 3, 2011 which includes
`information which is intended to address the identified deficiencies.
`
`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 2011-1111. 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 (Juvisync) thought to look or sound similar to
`Janumet XR 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 October 26, 2011.
`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 Juvisync and lead to medication errors. This analysis determined that the
`name similarity between Janumet XR and the identified name was unlikely to result in medication
`error for the reasons presented in Appendix A.
`Additionally, the Office of Prescription Drug Promotion re-reviewed the proposed name on August
`25, 2011 and had no concerns regarding the proposed name from a promotional perspective.
`
`3 CONCLUSIONS
`The re-evaluation of the proposed proprietary name, Janumet XR, 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, Janumet XR, for this product at this time. Since the
`Applicant submitted a Request for Proprietary Name Review, the comments in 3.1 will be
`communicated to the Applicant via letter.
`DMEPA considers this a final review; however, if approval of the NDA is delayed beyond 90 days
`from the date of this review, the Office of Metabolism and Endocrinology Products should notify
`DMEPA because the proprietary name must be re-reviewed prior to the new approval date.
`
`Reference ID: 3037501
`
`
`3
`
`

`

`If you have further questions or need clarifications, please contact Margarita Tossa, OSE project
`manager, at 301-796-4053.
`
`3.1 COMMENTS TO THE APPLICANT
`We have completed our review of the proposed proprietary name, Janumet XR, and have concluded
`that this name is acceptable for this product.
`
`
`
`Reference ID: 3037501
`
`
`4
`
`

`

`4 REFERENCES
`1.
`OSE Review 2011-1111, Janumet XR Proprietary Name Review, Abate, R. June 16, 2011.
`
`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/category/4782.html)
`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: 3037501
`
`
`5
`
`

`

`Appendix A: Risk of medication errors due to product confusion minimized by the dissimilarity of
`the names and/or use in clinical ractice for the reasons described.
`
`
`
` Failure Mode:
`
`Other Failures to Consider with this product
`
`Previously consideredfailures associated with the use
`ofthis product:
`
`0 Use Qfa modifier: a.failure that the modifier
`may be dropped.
`
`0 Using an altemative name: failure to identlfir
`duplicative therapy.
`
`Prevention of Failure Mode ( name confusion)
`
`Orthographic difference between these names stems
`from the fact that Juvisync includes the letter ‘y’ which
`provides a down stroke when scripted and lacks any
`modifier. Additionally. the name. Janumet XR. includes
`the letter ‘t’ at the end of the root name which may
`provide an upstroke and/or a cross stroke when scripted
`and also includes the modifier "’XR which provides
`added length to the name when scripted. These
`orthographic differences minimize the risk of confusion.
`
`In addition. both products are combination medications
`with strengths presented in terms of both drug
`components of the product. Although the strengths on
`the first and shared drug (sitagliptin) may overlap. the
`second strengths in the presentation are not similar and
`thus also provide differentiation. (10 mg. 20 mg. and
`40 mg vs. 1000 mg)
`
`Proposed name:
`
`Janumet XR
`
`Sitagliptin and
`Metformin HCl
`Extended release tablets
`
`50 mg1500 mg,
`50 mg11000 mg, and
`100 mg11000 mg tablets
`
`One tablet (any strength
`but recommended
`
`strength is 100 mg/
`1000 mg) by mouth daily
`or two tablets
`
`(50 mg/500 mg and
`50 mg11000 mg) by
`mouth daily. Maximum
`daily dose 100 mg of
`sitagliptin or 2000 mg of
`metformin HCl
`
`Juvisync
`
`(sitagliptin and simvastatin)
`
`100 rug/10 mg.
`100 mg/20 mg. and
`100 mg/40 mg tablets
`
`Usual dose: One tablet by
`mouth once daily
`
`Incorrect Product
`Ordered]
`
`Selected/Dispensed
`or Administered
`because of name
`confusion
`
`Orthographic
`similarity to the root
`name, Janumet:
`Both names begin
`with the same letter
`
`(J). have a letter
`
`grouping at the
`beginning of the
`name that may appear
`similar when scripted
`(Juvis— vs. Janu—). and
`have similar length
`when scripted.
`
`Product
`characteristics:
`
`Both Dl'OdllCtS include
`
`Reference ID: 3037501
`
`

`

`Sitagliptin as an
`active ingredient,
`share a numeric
`strength (100 mg) as
`part of a combination
`strength presentation,
`are oral tablets taken
`once a day, and are
`manufactured by
`Merck, Sharpe, and
`Dohme.
`
`
`
`
`
`Reference ID: 3037501
`
`
`7
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`RICHARD A ABATE
`11/01/2011
`
`CARLOS M MENA-GRILLASCA
`11/01/2011
`
`CAROL A HOLQUIST
`11/02/2011
`
`Reference ID: 3037501
`
`

`

`
`
`DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`
`
`
`Public Health Service
`Food and Drug Administration
`Silver Spring, MD 20993
`
`
`
`
`
`
`
`
`
`NDA 202270
`
`PROPRIETARY NAME REQUEST
`ACCEPTABLE
`
`
`Richard J. Swanson, PhD
`Senior Director, Worldwide Regulatory Affairs
`
`Merck Sharp & Dohme Corp.
`P.O. Box 1000, UG2C-50
`North Wales, PA 19454-1099
`
`Attention:
`
`
`
`Dear Dr. Swanson:
`
`Please refer to your New Drug Application (NDA) dated September 23, 2010, received
`September 23, 2010, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
`Act for Sitagliptin and Metformin Extended-release Tablets, 50 mg/500 mg, 50 mg/1000 mg, and
`100 mg/1000 mg.
`
`We also refer to your March 25, 2011, correspondence, received March 25, 2011, requesting
`review of your proposed proprietary name, Janumet XR, and we also refer to your June 22, 2011,
`correspondence, received June 22, 2011. We have completed our review of the proposed
`proprietary name, Janumet XR and have concluded that it is acceptable.
`
`The proposed proprietary name, Janumet XR, will be re-reviewed 90 days prior to the approval
`of the NDA. If we find the name unacceptable following the re-review, we will notify you.
`
`If any of the proposed product characteristics as stated in your March 25, 2011, submission are
`altered prior to approval of the marketing application, the proprietary name should be
`resubmitted for review.
`
`Reference ID: 2964879
`
`

`

`NDA 202270
`Page 2
`
`
`If you have any questions regarding the contents of this letter or any other aspects of the
`proprietary name review process, contact Margarita Tossa, Safety Regulatory Project Manager in
`the Office of Surveillance and Epidemiology, at (301) 796-4053. For any other information
`regarding this application contact the Office of New Drugs (OND) Regulatory Project Manager
`Raymond Chiang at (301) 796-1940.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`
`
`
`
`Carol Holquist, RPh
`Director
`Division of Medication Error Prevention and Analysis
`Office of Medication Error Prevention and Risk Management
`Office of Surveillance and Epidemiology
`
`
`
`
`
`
`Reference ID: 2964879
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`MARGARITA V TOSSA
`06/23/2011
`
`CAROL A HOLQUIST
`06/23/2011
`
`Reference ID: 2964879
`
`

`

`
`
`DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`
`
`
`Public Health Service
`Food and Drug Administration
`Silver Spring, MD 20993
`
`
`
`
`
`
`
`
`
`NDA 202270
`
`PROPRIETARY NAME REQUEST
`CONDITIONALLY ACCEPTABLE
`
`
`Richard J. Swanson, PhD
`Senior Director, Worldwide Regulatory Affairs
`
`Merck Sharp & Dohme Corp.
`P.O. Box 1000, UG2C-50
`North Wales, PA 19454-1099
`
`Attention:
`
`
`
`Dear Dr. Swanson:
`
`Please refer to your New Drug Application (NDA) dated September 23, 2010, received
`September 23, 2010, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
`Act for Sitagliptin and Metformin Extended-release Tablets, 50 mg/500 mg and 50 mg/1000 mg.
`
`We also refer to your March 25, 2011, correspondence, received March 25, 2011, requesting
`review of your proposed proprietary name, Janumet XR. We have completed our review of the
`proposed proprietary name, Janumet XR and have concluded that it is acceptable.
`
`The proposed proprietary name, Janumet XR, will be re-reviewed 90 days prior to the approval
`of the NDA. If we find the name unacceptable following the re-review, we will notify you.
`
`If any of the proposed product characteristics as stated in your March 25, 2011, submission are
`altered prior to approval of the marketing application, the proprietary name should be
`resubmitted for review.
`
`Reference ID: 2958221
`
`

`

`NDA 202270
`Page 2
`
`
`If you have any questions regarding the contents of this letter or any other aspects of the
`proprietary name review process, contact Margarita Tossa, Safety Regulatory Project Manager in
`the Office of Surveillance and Epidemiology, at (301) 796-4053. For any other information
`regarding this application contact the Office of New Drugs (OND) Regulatory Project Manager
`Patricia Madara at (301) 796-1249.
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`
`
`
`
`Carol Holquist, RPh
`Director
`Division of Medication Error Prevention and Analysis
`Office of Medication Error Prevention and Risk Management
`Office of Surveillance and Epidemiology
`
`
`
`
`
`
`Reference ID: 2958221
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`CAROL A HOLQUIST
`06/16/2011
`
`Reference ID: 2958221
`
`

`

`
`
`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:
`
`June 15, 2011
`
`Richard Abate, RPh, MS, Safety Evaluator
`Reviewer:
`Division of Medication Error Prevention and Analysis
`
`Lubna Merchant, MS, PharmD, Acting Team Leader
`Team Leader:
`Division of Medication Error Prevention and Analysis
`
`Carol Holquist, RPh, Director
`Division Director:
`Division of Medication Error Prevention and Analysis
`
`Drug Names and Strengths: Janumet XR (Sitagliptin and Metformin HCl Extended-
`release) Tablets 50 mg/500 mg, 50 mg/1000 mg, and
`100 mg/1000 mg
`Application Type/Number: NDA 202270
`Applicant:
`Merck Sharp and Dohme Corp.
`OSE RCM #:
`2011-1111
`*** This document contains proprietary and confidential information that should not be
`released to the public.***
`
`***This document contains proprietary data from the Institute for Safe Medication
`Practices (ISMP) and Quantros MedMARX which cannot be shared outside of the
`FDA. Users wanting this information must contact Matthew Grissinger, RPh, FISMP,
`FASCP, Director, Error Reporting Programs at ISMP***
`
`
`
`
`Reference ID: 2961074
`
`
`
`

`

`
`
`CONTENTS
`
`1
`
`INTRODUCTION................................................................................................................... 1
`1.1
`Regulatory History......................................................................................................... 1
`1.2
`Product Information ....................................................................................................... 1
`2 RESULTS................................................................................................................................ 1
`2.1
`Promotional Assessment................................................................................................ 1
`2.2
`Safety Assessment.......................................................................................................... 1
`3 DISCUSSION ......................................................................................................................... 5
`3.1
`Janumet Plus Modifier ‘XR’ .......................................................................................... 6
`3.2
`Use of an Alternate Name.............................................................................................. 7
`4 CONCLUSIONS ..................................................................................................................... 7
`4.1
`Comments to the Applicant............................................................................................ 8
`5 REFERENCES........................................................................................................................ 9
`APPENDICES............................................................................................................................... 12
`
`
`
`
`
`Reference ID: 2961074
`
`
`
`

`

`
`
`1
`INTRODUCTION
`This review evaluates the proposed proprietary name, Janumet XR, 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
`Janumet (sitagliptin and metformin HCl) tablets (NDA 022044) was approved March 30,
`2007. Prior to approval of NDA 022044, the Division of Medication Error Prevention
`and Analysis evaluated the name, Janumet, in OSE review # 2006-462 dated March 15,
`2007. DMEPA recommended not to use the proprietary name, Janumet, due to likely
`confusion with Januvia and Sinemet would result in medication errors. Since approval,
`medication errors have been reported between these name pairs.
`
`1.2 PRODUCT INFORMATION
`Janumet XR (Sitagliptin and Metformin HCl Extended-release) tablets is under
`evaluation for use as an adjunct to exercise and diet to improve glycemic control in adults
`with type 2 diabetes mellitus. These tablets are formulated to release sitagliptin
`immediately and have an extended-release mechanism for the metformin. Janumet XR
`will be available as 50 mg/500 mg, 50 mg/1000 mg, and 100 mg/1000 mg tablets. The
`dose is one (100 mg/1000 mg) tablet or two (50 mg/500 mg or 50 mg/1000 mg) tablets
`taken orally once a day but is determined by the amount of metformin the patient
`requires. The maximum daily dose is 100 mg of sitagliptin and 2000 mg of metformin.
`Janumet XR 50 mg/500 mg and 50 mg/1000 mg tablets will be marketed in bottles
`containing 60, 180, and 1000 tablets. The 100 mg/1000 mg tablets will be marketed in
`bottles containing 30, 90, and 100 tablets. Janumet XR is stored at room temperature.
`
`2 RESULTS
`The following sections provide the information obtained and considered in the evaluation
`of the proposed proprietary name.
`
`2.1 PROMOTIONAL ASSESSMENT
`DDMAC determined the proposed name is acceptable from a promotional perspective.
`DMEPA and the Division of Metabolism and Endocrinology Products concurred with
`the findings of DDMAC’s promotional assessment of the proposed name.
`
`2.2 SAFETY ASSESSMENT
`The following aspects of the name are considered in the overall assessment.
`
`2.2.1 United States Adopted Names (USAN) SEARCH
`The United States Adopted Name (USAN) stem search conducted on April 21, 2011
`identified that a USAN stem is not present in the proposed proprietary name.
`
`Reference ID: 2961074
`
`
`1
`
`

`

`
`
`2.2.2 Components of the Proposed Proprietary Name
`The proposed proprietary name includes the modifier, XR, to represent the extended
`release properties of this formulation and differentiate it from the approved Janumet
`product. The modifier, XR, is used for extended release products only. In addition, the
`most recent use of this modifier has been with products administered once a day. Thus,
`the inclusion of the modifier in Janumet XR is appropriate for this product.
`However, DMEPA noted the immediate release formulation and this proposed extended-
`release formulation share overlapping product characteristics that add to the potential for
`confusion between Janumet and Janumet XR. We discuss these findings in Section 3.
`
`2.2.3 Postmarketing Medication Error Data Evaluated
`Janumet is a marketed product. In addition, DMEPA found the proprietary name
`Janumet likely to be confused with Januvia and Sinemet resulting in medication errors in
`our review OSE review# 2006-462. Thus, DMEPA searched various databases for
`medication errors involving Janumet which would be relevant for this review. The
`results of these searches are described in the following subsections.
`
`2.2.3.1 FDA Adverse Event Reporting System (AERS) Selection of Cases
`DMEPA searched the Adverse Event Reporting System (AERS) database on March 29,
`2011 using the following search terms: trade name “Janumet%”; verbatim terms
`“Janume%” and “Sitagliptin%,” selecting only those sitagliptin terms that also included
`Metformin; and the MedDRA High Level Group Term (HLGT) “Medication Errors,” and
`High Level Terms (HLT) “Product Label Issues” and “Product Quality Issues NEC.” No
`time limit was set.
`The reports were manually reviewed to determine if a medication error occurred.
`Duplicate reports were combined into cases. The cases that described a medication error
`were categorized by type of error. We reviewed the cases within each category to
`identify factors that contributed to the medication errors. If a root cause was associated
`with Janumet name confusion, the case was considered pertinent to this review. Reports
`excluded from the case series include those that did not describe a medication error,
`describe Janumet as a concomitant medication not involved in the medication error, or
`described a product complaint. The medication errors associated with the labels and
`labeling of Janumet will be discussed in DMEPA’s review for the proposed labels and
`labeling of Janumet XR (OSE review # 2010-2299).
`Following exclusions, the search yielded four relevant cases (n=4) of wrong drug
`medication errors. The ISR numbers for these cases appear in Appendix I.
`• Confusion with Sinemet (n=2): These cases reported in 2007 Describe confusion
`between Sinemet and Janumet. The first case describes a pharmacist confusing an
`order for “Janumet 50 /500” for Sinemet and entered the incorrect medication into
`the pharmacy computer. However, the error was noted by a second pharmacist
`prior to dispensing the medication. In the remaining case, the pharmacist
`confused an order for Janumet 50 mg/500 mg as Sinemet, but called to clarify the
`dose with the prescriber who stated the medication should be Janumet.
`
`Reference ID: 2961074
`
`
`2
`
`

`

`
`
`• Confusion with Januvia (n=1): This case from 2007 noted the patient returned a
`professional sample bottle of Januvia 100 mg tablets stating the tablets appeared
`to be Janumet which he was to begin after he finished his current prescription of
`Metformin. The nurse checked the contents of the vial and reported its contents
`as 42 Janumet tablets and three Januvia tablets.
`• Confusion between Jantoven, Januvia and Janumet (n=1): This 2008 case
`describes multiple prescribers requesting drug information on Jantoven believing
`it contained sitagliptin or indicated for diabetes mellitus, similar to Januvia or
`Janumet. The reporter noted several medication errors were avoided due to
`prescriber confusion but without providing further detail.
`
`2.2.3.2 Institute of Safe Medication Practices Database Selection of Cases***
`DMEPA requested the Institute of Safe Medication Practices (ISMP) search its databases
`for medication errors involving Janumet on May 12, 2011, specifically cases of name
`confusion. DMEPA excluded cases if they did not involve Janumet, name confusion
`with Janumet or medication error types such as wrong strength or wrong dose.
`Following exclusions, the search yielded eight relevant cases. The cases did not describe
`the event or provide patient outcome. Evaluation of the cases noted were duplicates of
`cases identified in the AERS database. The remaining six medication error cases are
`listed below.
`• Confusion with Januvia (n=3)
`• Confusion with Jantoven (n=2)
`• Confusion with Sinemet (n=1)
`
`2.2.3.3 Merck Database Selection of cases
`DMEPA requested Merck provide reports from their company database that described
`confusion involving Janumet regardless of patient outcome in an email dated May 23,
`2011. Merck provided six reports of medication errors, three of which were relevant to
`this review. DMEPA’s evaluation of the cases noted them to be duplicates of cases
`identified in the AERS search.
`
`2.2.4 FDA Name Simulation Studies
`Thirty-five practitioners participated in DMEPA’s prescription studies. However, one
`respondent recorded the responses to all the included samples incorrectly. Therefore, the
`responses provided by this participant were discarded from this simulation study (April
`15, 2011). We utilized the responses from the remaining 34 participants for this review.
`See Appendix D for the complete listing of interpretations from the verbal and written
`prescription studies. We noted one respondent misinterpreted the ‘J’ as an ‘S’ similar to
`
`
`*** This document contains proprietary data from the Institute for Safe Medication Practices (ISMP) and
`Quantros MedMARX databases which cannot be shared outside of the FDA. ***
`
`
`Reference ID: 2961074
`
`
`3
`
`

`

`Sinemet. However, 31 of the 34 respondents interpreted the name correctly as “Janumet
`XR- ,,
`
`2.2.5 Comments from Other Review Disciplines
`
`The Division of Metabolism and Endocrinology Product (DMEP) did not forward any
`comments or concerns relating to the proposed name at the initial phase of the name
`review.
`
`DMEPA communicated our findings to the DMEP at the NDA wrap-up meeting May 24,
`2011. At that time we also requested additional information or concerns that could
`inform our review. Per e-mail correspondence from the Division of Metabolic and
`Endocrinology Products on May 31, 2011, they stated no additional concerns with the
`proposed proprietary name, Janumet XR.
`
`2.2. 6 Failure Mode and Effects Analysis ofSimilar Names
`
`Table 1 lists the names with orthographic, phonetic, or spelling similarity to the proposed
`proprietary name, Janumet XR (see Appendix C). These names were identified by the
`primary reviewer, the Expert Panel Discussion (EPD), other review disciplines.
`
`Table l: Collective List of Potentially Similar Names (DMEPA, EPD and Other Disciplines)
`
`Look Similar
`
`Look and Sound Similar
`
`Name
`
`Source
`
`Name
`
`Source
`
`Anumed HC
`
`EPD search
`
`Granumed
`
`EPD search for
`
`look and primary
`SE for sound
`
`Anumed
`
`EPD search
`
`Jantoven
`
`EPD search for
`
`look and primary
`SE for sound!
`AERS
`
`Anzemet
`
`EPD search
`
`Janumet
`
`EPD search
`
`Cesamet
`
`EPD search
`
`Januvia
`
`EPD search] AERS
`
`Fioricet
`
`EPD search
`
`Janumet XR
`
`EPD search
`
`Fion'nal
`
`EPD search
`
`Jolivette
`
`EPD search
`
`Fortamet
`
`EPD search
`
`Prandimet
`
`EPD search look
`
`and primary SE
`sound
`
`Ganirelix
`Acetate
`
`EPD search
`
`Glumetza
`
`EPD search
`
`Jenest -28
`
`EPD search
`
`Taclonex
`
`EPD search
`
`Reference ID: 2961074
`
`4
`
`

`

`Look Similar
`
`Name
`
`Source
`
`Tavist
`
`EPD search
`
`Tonocard
`
`EPD search
`
`Lamictal XR
`
`EPD search
`
`Namcnda XR EPD search
`
`Sinemet
`
`EPD
`search/AERS
`
`Sinemet CR
`
`EPD search
`
`Tagamet
`
`EPD search
`
`Tagamet HB
`
`EPD search
`
`Tanoral
`
`EPD search
`
`Temovatc
`
`EPD search
`
`Timentin
`
`EPD search
`
`Travasol
`
`EPD search
`
`Our analysis of the 30 names contained in Table 1 considered the information obtained in
`the previous sections along with the product characteristics. We determined the proposed
`name, Janumet XR, would perpetuate the previously identified confusion with Januvia,
`Jantoven, and Sinemet (including Sinemet CR) as described in Appendix E-G. We also
`noted the safety concerns of handling this product with an alternative name in Appendix
`H. We discuss our findings in Section 3 below.
`
`3 DISCUSSION
`
`Prior to the initial approval of Janumet (NDA 022044), DMEPA concluded that the name
`Janumet was unacceptable due to its potential to be confused with Januvia and Sinemet.
`However, the Division approved the name for market. Since marketing, errors with these
`name pairs have occurred as well as confusion with Jantoven. The majority of the
`reported medication errors occurred at the launch of the product with the last case
`reported in 2009. Due to postmarketing errors, the Institute for Safe Medication Practice
`(ISMP) placed Janumet on their list of confiised drug names.1
`
`The name, Janumet, was a root cause to these medication errors because of its similarity
`to Jantoven, Januvia and Sinemet. However, it is also likely that the relatively short time
`between the launch of Januvia and Janumet (six months) as well as the minimal number
`of proprietary names beginning with the letter ‘J’ also contributed to some of the
`medication errors. Furthermore, it appears healthcare pro