CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022141Orig1s000 PROPRIETARY NAME REVIEW(S) PROPRIETARY NAME REVIEW 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*** **This document contains proprietary drug use data obtained by FDA under contract. The drug use data/information cannot be released to the public/non-FDA personnel without contractor approval obtained through the FDA/CDER Office of Surveillance and Epidemiology.** Date of This Review: November 17, 2017 Application Type and Number: NDA 22141 Product Name and Strength: Cimduo (lamivudine and tenofovir disoproxil fumarate) Tablet, 300 mg/300 mg Product Type: Multi-Ingredient Product Rx or OTC: Rx Applicant/Sponsor Name: Mylan Laboratories Limited Panorama #: 2017-17380716 DMEPA Safety Evaluator: Valerie S. Wilson, PharmD DMEPA Team Leader: Otto L. Townsend, PharmD Reference ID: 4183434 Contents 1 INTRODUCTION....................................................................................................................1 1.1 Product Information ..........................................................................................................1 2 RESULTS.................................................................................................................................1 2.1 Misbranding Assessment ..................................................................................................1 2.2 Safety Assessment.............................................................................................................1 3 CONCLUSIONS......................................................................................................................3 3.1 Comments to the Applicant...............................................................................................3 4 REFERENCES.........................................................................................................................4 APPENDICES .................................................................................................................................5 Reference ID: 4183434 1 INTRODUCTION This review evaluates the proposed proprietary name, Cimduo, from a safety and misbranding perspective. The sources and methods used to evaluate the proposed name are outlined in the reference section and Appendix A respectively. The Applicant submitted an external name study, conducted by (b) (4) , for this product. 1.1 PRODUCT INFORMATION The following product information is provided in the August 31, 2017 proprietary name submission. Intended Pronunciation: sim-DEW-oh Active Ingredient: lamivudine and tenofovir disoproxil fumarate Indication of Use: Treatment of HIV-1 infection Route of Administration: Oral Dosage Form: Tablet Strength: 300 mg/300 mg Dose and Frequency: 1 tablet orally once daily How Supplied: Bottles of 30, 90,(b) (4) tablets Storage: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep the bottle tightly closed. Dispense in original container. 2 RESULTS The following sections provide information obtained and considered in the overall evaluation of the proposed proprietary name. 2.1 MISBRANDING ASSESSMENT The Office of Prescription Drug Promotion (OPDP) determined that the proposed name would not misbrand the proposed product. The Division of Medication Error Prevention and Analysis (DMEPA) and the Division of Antiviral Products (DAVP) concurred with the findings of OPDP’s assessment of the proposed name. 2.2 SAFETY ASSESSMENT The following aspects were considered in the safety evaluation of the name. 2.2.1 United States Adopted Names (USAN) Search There is no USAN stem present in the proprietary namea. a USAN stem search conducted on September 7, 2017. Reference ID: 4183434 1 2.2.2 Components of the Proposed Proprietary Name The Applicant stated in their submission that Cimduo is not derived from any one concept. 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 Comments from Other Review Disciplines at Initial Review In response to the OSE, September 13, 2017 e-mail, the Division of Antiviral Products (DAVP) did not forward any comments or concerns relating to the proposed proprietary name at the initial phase of the review. 2.2.4 FDA Name Simulation Studies Seventy-two practitioners participated in DMEPA’s prescription studies. The responses did not overlap with any currently marketed products nor did the responses sound or look similar to any currently marketed products or any products in the pipeline. Appendix B contains the results from the verbal and written prescription studies. 2.2.5 Phonetic and Orthographic Computer Analysis (POCA) Search Results Our POCA searchb identified 20 names with a combined phonetic and orthographic score of ≥55% or an individual phonetic or orthographic score ≥70. These names are included in Table 1 below. 2.2.6 Names Retrieved for Review Organized by Name Pair Similarity Table 1 lists the number of names retrieved from our POCA search and the (b) (4) external study. These name pairs are organized as highly similar, moderately similar or low similarity for further evaluation. Table 1. Similarity Category Number of Names Highly similar name pair: 1 combined match percentage score ≥70% Moderately similar name pair: 19 combined match percentage score ≥55% to ≤ 69% Low similarity name pair: 7 combined match percentage score ≤54% b POCA search conducted on September 7, 2017 in version 4.2. Reference ID: 4183434 2 2.2.7 Safety Analysis of Names with Potential Orthographic, Spelling, and Phonetic Similarities Our analysis of the 27 names contained in Table 1 determined none will pose a risk for confusion as described in Appendices C through H. 2.2.8 Communication of DMEPA’s Analysis at Midpoint of Review DMEPA communicated our findings to the Division of Division of Antiviral Products (DAVP) via e-mail on November 15, 2017. At that time, we also requested additional information or concerns that could inform our review. Per e-mail correspondence from DAVP on November 15, 2017, they stated that there is concern for confusion between the names Cimduo and Symtuza***. We evaluated the name pair further to determine if there is sufficient orthographic, phonetic, and product characteristic differences to mitigate the risk of name confusion. Phonetically, the third syllables of this name pair (i.e. -oh and -zah) sound different. We acknowledge that the 2nd syllables of this name pair (i.e. -DEW- and -toó-) could sound similar when spoken; however, we note that during the verbal DMPEA prescription studies, there was no misinterpretation of the letter “d” in Cimduo for the letter “t”. Likewise, during the verbal DMEPA prescription studies for Symtuza***, there was no misinterpretation of the letter “t” for the letter “d”. Orthographically, Cimduo begins with the letter “C” that when scripted looks different from the beginning letter “S” in Symtuza***. Symtuza*** contains the down-stroke letter “y” in its prefix and the cross-stroke letter “t” in its suffix which is not contained in Cimduo. The letter “z” in Symtuza*** affords an additional orthographic difference whether scripted in cursive font with a down-stroke or scripted in printed font. Additionally, there is no numerical similarity or numerical overlap between the strengths of these two products. Based on the above, we find there is a sufficient combination of orthographic, phonetic, and product characteristic differences to mitigate confusion between this name pair. This is further supported by a combined POCA score of 48%, which indicates this name pair has low similarity. 3 CONCLUSIONS The proposed proprietary name is acceptable. If you have any questions or need clarifications, please contact Danyal Chaudhry, OSE project manager, at 301-796-3813. 3.1 COMMENTS TO THE APPLICANT We have completed our review of the proposed proprietary name, Cimduo, and have concluded that this name is acceptable. If any of the proposed product characteristics as stated in your August 31, 2017 submission are altered prior to approval of the marketing application, the name must be resubmitted for review. Reference ID: 4183434 3 4 REFERENCES 1. 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. 2. Phonetic and Orthographic Computer Analysis (POCA) POCA is a system that FDA designed. As part of the name similarity assessment, POCA is used to evaluate proposed names via a phonetic and orthographic algorithm. The proposed proprietary name is converted into its phonemic representation before it runs through the phonetic algorithm. Likewise, an orthographic algorithm exists that operates in a similar fashion. POCA is publicly accessible. Drugs@FDA Drugs@FDA is an FDA Web site that contains most of the drug products approved in the United States 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