[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-0-en-105":3,"doc-seo-403039-105":59,"doc-detail-403039-en":130},{"code":4,"msg":5,"data":6},0,"success",[7,13,18,23,28,33,38,43,48,51,55],{"id":8,"doc_module":4,"doc_module_name":9,"category_name":10,"show_sort_weight":11,"slug":12},1,"Document","Story & Novel",90,"story-novel",{"id":14,"doc_module":4,"doc_module_name":9,"category_name":15,"show_sort_weight":16,"slug":17},2,"Literature",80,"literature",{"id":19,"doc_module":4,"doc_module_name":9,"category_name":20,"show_sort_weight":21,"slug":22},4,"Exam",70,"exam",{"id":24,"doc_module":4,"doc_module_name":9,"category_name":25,"show_sort_weight":26,"slug":27},5,"Comic",60,"comic",{"id":29,"doc_module":4,"doc_module_name":9,"category_name":30,"show_sort_weight":31,"slug":32},6,"Technology",50,"technology",{"id":34,"doc_module":4,"doc_module_name":9,"category_name":35,"show_sort_weight":36,"slug":37},7,"Healthcare",40,"healthcare",{"id":39,"doc_module":4,"doc_module_name":9,"category_name":40,"show_sort_weight":41,"slug":42},8,"Research & Report",30,"research-report",{"id":44,"doc_module":4,"doc_module_name":9,"category_name":45,"show_sort_weight":46,"slug":47},9,"Religion & Spirituality",20,"religion-spirituality",{"id":46,"doc_module":4,"doc_module_name":9,"category_name":49,"show_sort_weight":46,"slug":50},"World Cup","world-cup",{"id":52,"doc_module":4,"doc_module_name":9,"category_name":53,"show_sort_weight":52,"slug":54},10,"Lifestyle","lifestyle",{"id":56,"doc_module":4,"doc_module_name":9,"category_name":57,"show_sort_weight":24,"slug":58},19,"General","general",{"code":4,"msg":60,"data":61},"ok",{"site_id":62,"language":63,"slug":64,"title":65,"keywords":66,"description":67,"schema_data":68,"social_meta":123,"head_meta":125,"extra_data":127,"updated_unix":129},105,"en","proprietary-name-review-proprietary-name-review-suprep-bowel-prep-kit","Proprietary Name Review - Proprietary Name Review - Suprep Bowel Prep Kit","","Re-assessment of the proposed proprietary drug name, Suprep Bowel Prep Kit (Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate) Oral Solution, conducted in response to anticipated NDA approval. The Division of Medication Error Prevention and Analysis searched standard databases and sources for orthographic and phonetic similarities to identify any newly approved names since prior reviews, and re-used the earlier search criteria because product characteristics did not change. The review also checked the USAN stem list for stems in the proposed name and applied an FMEA-focused risk assessment centered on avoiding medication errors. No new potentially confusing similar names or USAN stems were identified; the division had no objection, with guidance to re-review if approval is delayed beyond 90 days.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/proprietary-name-review-proprietary-name-review-suprep-bowel-prep-kit/403039/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/proprietary-name-review-proprietary-name-review-suprep-bowel-prep-kit/403039.png","ImageObject",300,407,{"name":92,"@type":93},"Miles","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-29","2026-09-27",true,{"@type":102,"interactionType":103,"userInteractionCount":39},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"Why was this proprietary name re-assessment performed?","Question",{"text":112,"@type":113},"It was written in response to the anticipated approval of the NDA within 90 days from the date of the review.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"What search methods were used to evaluate potential name confusion?",{"text":117,"@type":113},"DMEPA staff searched standard databases and information sources to find orthographic and phonetic similarities to the proposed name, using the same search criteria as a prior OSE proprietary name review.",{"name":119,"@type":110,"acceptedAnswer":120},"Did the review find any USAN stems or similar approved names?",{"text":121,"@type":113},"No. The review did not identify USAN stems in the proposed proprietary name as of April 30, 2010, and no newly approved names thought to look or sound similar were found since the last review.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},403039,1790949098,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":39,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145,"preview_page_count":4},13056703019404,"https://ap-avatar.wpscdn.com/davatar_29158cc5080c5b710cf443261637dec0","CENTER FOR DRUG EVALUATION AND  \nRESEARCH  \nAPPLICATION NUMBER:  \n022372Orig1s000  \nPROPRIETARY NAME REVIEW(S)  \nDepartment of Health and Human Services Public Health Service  \nFood and Drug Administration  \nCenter for Drug Evaluation and Research Office of Surveillance and Epidemiology  \nDate: May 6, 2010  \nTo: Donna Griebel, MD, Director  \nDivision of Gastroenterology Products  \nThrough: Melina Griffis, R.Ph, Team Leader  \nDenise P. Toyer, PharmD, Deputy Director  \nDivision of Medication Error Prevention and Analysis (DMEPA)  \nFrom: Anne Crandall, PharmD. Safety Evaluator  \nDivision of Medication Error Prevention and Analysis (DMEPA)  \nSubject: Proprietary Name Review  \nDrug Name(s): Suprep Bowel Prep Kit (Sodium Sulfate, Potassium Sulfate, and  \nMagnesium Sulfate) Oral Solution, 17.5 g/3.13 g/1.6 g  \nApplication Type/Number: NDA 022372  \nApplicant: Braintree Laboratories, Inc  \nOSE RCM \\#: 2010-809  \nCONTENTS  \n1 INTRODUCTION ................................................................................................................... 3  \n2 METHODS AND RESULTS .................................................................................................. 3  \n3 CONCLUSIONS AND RECOMMENDATIONS .................................................................. 3  \n4 REFERENCES ........................................................................................................................ 4  \n1 INTRODUCTION  \nThis re-assessment of the proposed proprietary name, Suprep Bowel Prep Kit, 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, Suprep Bowel Prep Kit, acceptable in OSE Review \\#2008-1436 dated April 16, 2009 and OSE Reviews \\#2009-888 dated August 10, 2009 and January 10, 2010. DDMAC reviewed the proposed name on September 17, 2008 and had no concerns regarding the proposed name from a promotional perspective. Furthermore, thereview Division did not have any concerns with the proposed name, Suprep Bowel Prep Kit, during our initial review.  \n2 METHODS AND RESULTS  \nFor the proposed proprietary name, DMEPA staff search 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. We used the same search criteria used in OSE Review \\#2008-1436 for the proposed proprietary name, Suprep Bowel Prep Kit. Since none of the proposed product characteristics were altered we did not re-evaluate previous names of concern.  \nAdditionally, DMEPA searched the USAN stem list to determine if the name contains any USAN stems as of the last USAN updates. 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. The searches of the databases did not yield any new names thought to look or sound similar to Suprep Bowel Prep Kit and represent a potential source of drug name confusion. Additionally, DMEPA staff did not identify any United States Adopted Names (USAN) stems in the proposed proprietary name, as of April 30, 2010.  \n3 CONCLUSIONS AND RECOMMENDATIONS  \nThe re-review of the proposed proprietary name, Suprep Bowel Prep Kit, did not identify any additional names thought to look or sound similar to the proposed name since our last review. Thus, the Division of Medication Error Prevention and Analysis (DMEPA) has no objection to the proprietary name, Suprep Bowel Prep Kit, for this product at this time.  \nDMEPA 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 Products should notify DMEPA because the proprietary name must be re-reviewed prior to the new approval date.  \n4 REFERENCES  \n1. OSE reviews \\# 2008-1436 Proprietary Name and Label Review of Suprep","cbCailTGAQ62nWis","https://ap.wps.com/l/cbCailTGAQ62nWis","pdf",264227,41,"English","# CONTENTS\n## 1 INTRODUCTION\n## 2 METHODS AND RESULTS\n## 3 CONCLUSIONS AND RECOMMENDATIONS\n## 4 REFERENCES","[{\"question\":\"Why was this proprietary name re-assessment performed?\",\"answer\":\"It was written in response to the anticipated approval of the NDA within 90 days from the date of the review.\"},{\"question\":\"What search methods were used to evaluate potential name confusion?\",\"answer\":\"DMEPA staff searched standard databases and information sources to find orthographic and phonetic similarities to the proposed name, using the same search criteria as a prior OSE proprietary name review.\"},{\"question\":\"Did the review find any USAN stems or similar approved names?\",\"answer\":\"No. The review did not identify USAN stems in the proposed proprietary name as of April 30, 2010, and no newly approved names thought to look or sound similar were found since the last review.\"}]","Proprietary Name Review - Proprietary Name Review - Suprep Bowel Prep Kit | PDF",1790536824,103]