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206185Orig1s000 CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 206185Orig1s000 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*** Date of This Review: July 10, 2018 Application Type and Number: NDA 206185 Product Name and Strength: Xelpros (Latanoprost) Ophthalmic Emulsion, 0.005% Product Type: Single-Ingredient Product Rx or OTC: Rx Applicant/Sponsor Name: Sun Pharma Global FZE Panorama #: 2018-23225165 DMEPA Safety Evaluator: Deborah Myers, RPh, MBA DMEPA Team Leader: Otto L. Townsend, PharmD Reference ID: 4289080 Contents 1 INTRODUCTION....................................................................................................................1 1.1 Regulatory History............................................................................................................1 1.2 Product Information ..........................................................................................................1 2 RESULTS.................................................................................................................................2 2.1 Misbranding Assessment ..................................................................................................2 2.2 Safety Assessment.............................................................................................................2 3 CONCLUSION ........................................................................................................................3 3.1 Comments to the Applicant...............................................................................................4 4 REFERENCES.........................................................................................................................5 APPENDICES .................................................................................................................................6 Reference ID: 4289080 1 INTRODUCTION This review evaluates the proposed proprietary name, Xelpros, 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 re-submitted an external name study, previously conducted by (b) (4) , that DMEPA evaluated in our prior review. 1.1 REGULATORY HISTORY The Division of Medication Error Prevention and Analysis (DMEPA) found the name Xelpros*** conditionally acceptable under NDA 206185.a Subsequently, on July 30, 2015, the Division of Transplant and Ophthalmology Products (DTOP) issued a Complete Response (CR) for the application. The Applicant re-submitted the application on July 28, 2016, and re-submitted the proposed proprietary name, Xelpros***, for our review. Again, we found the name, Xelpros***, conditionally acceptable on September 28, 2016.b Subsequently, on December 19, 2016, DTOP issued a CR for the Application. On November 30, 2017, a request was submitted to extend the time to resubmit the NDA to the CR letter on December 19, 2016. Notification of the transfer of the NDA sponsorship from Sun Pharma Advanced Research Company, Ltd. to Sun Pharma Global FZE (SUN FZE) was received by the Agency on April 12, 2018. Subsequently, the Applicant re-submitted the application on May 7, 2018, and re-submitted the proposed proprietary name, Xelpros***, for our review on May 22, 2018. 1.2 PRODUCT INFORMATION The following product information is provided in the proprietary name submission received on May 22, 2018. Intended Pronunciation: Zel' prose Active Ingredient: latanoprost Indication of Use: reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Route of Administration: ophthalmic Dosage Form: sterile ophthalmic emulsion a Kapoor, R. Proprietary Name Review for Xelpros*** (NDA 206185). Silver Spring (MD): FDA, CDER, OSE, DMEPA (US); 2014 MAY 13. Panorama No. 2014-17043. b Owens, L. Proprietary Name Review for Xelpros*** (NDA 206185). Silver Spring (MD): FDA, CDER, OSE, DMEPA (US); 2016 SEP 28. Panorama No. 2016-9946033. 1 Reference ID: 4289080 Strength: 0.005% (50 mcg/mL) Dose and Frequency: One drop in the affected eye(s) once daily in the evening. How Supplied: 2.5 mL emulsion filled in a 5 mL clear low density polyethylene bottle with a clear low density polyethylene dropper tip, and a turquoise high density polyethylene pilfer-proof cap. o Package of 1 bottle o Multi-pack of 3 bottles Storage: Protect from light. Store (b) (4) to 25°C (77°F). (b) (4) The bottle may be maintained at temperature up to 40°C (104°F) for a period not exceeding (b) (4) (b) (4) 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 Transplant and Ophthalmology Products (DTOP) 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 namec. 2.2.2 Components of the Proposed Proprietary Name The Applicant did not provide a derivation or intended meaning for the proposed name, Xelpros in their submission. 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, June 6, 2018 e-mail, the Division of Transplant and Ophthalmology Products (DTOP) did not forward any comments or concerns relating to the proposed proprietary name at the initial phase of the review. c USAN stem search conducted on May 23, 2018. 2 Reference ID: 4289080 2.2.4 FDA Name Simulation Studies Fifty-three 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 searchd identified 99 names with the combined score of ≥55% or individual orthographic or phonetic score of ≥70%. We had identified and evaluated some of the names in our previous proprietary name reviews. We re-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 name. We note that none of the product characteristics have changed and we agree with the findings from our previous review for the names evaluated previously. Therefore, we identified 30 names not previously analyzed. These names are included in Table 1 below. Table 1. Similarity Category Number of Names Highly similar name pair: 0 combined match percentage score ≥70% Moderately similar name pair: 30 combined match percentage score ≥55% to ≤ 69% Low similarity name pair: 0 combined match percentage score ≤54% 2.2.6 Safety Analysis of Names with Potential Orthographic, Spelling, and Phonetic Similarities Our analysis of the thirty names contained in Table 1 determined none of the names will pose a risk for confusion as described in Appendices C through H. 2.2.7 Communication of DMEPA’s Analysis at Midpoint of Review DMEPA communicated our findings to the Division of Transplant and Ophthalmology Products (DTOP) via e-mail on June 25, 2018. At that time, we also requested additional information or concerns that could inform our review. Per e-mail correspondence from DTOP on July 10, 2018, they stated no additional concerns with the proposed proprietary name, Xelpros. 3 CONCLUSION The proposed proprietary name is acceptable. d POCA search conducted on May 23, 2018 in version 4.2. 3 Reference ID: 4289080 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, Xelpros, and have concluded that this name is acceptable. If any of the proposed product characteristics as stated in your submission, received on May 22, 2018, are altered prior to approval of the marketing application, the name must be resubmitted for review. 4 Reference ID: 4289080 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
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