[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-seo-403040-105":3,"detail-sidebar-cat-0-en-105":85,"doc-detail-403040-en":135},{"code":4,"msg":5,"data":6},0,"ok",{"site_id":7,"language":8,"slug":9,"title":10,"keywords":11,"description":12,"schema_data":13,"social_meta":78,"head_meta":80,"extra_data":82,"updated_unix":84},105,"en","suprep-bowel-prep-kit-division-director-summary-review-approval","SUPREP Bowel Prep Kit - Division Director Summary Review - Approval","","Division Director Summary Review for Regulatory Action evaluates NDA 022372 for the proposed bowel cleanser SUPREP Bowel Prep Kit (sodium sulfate, potassium sulfate, magnesium sulfate oral solution) intended to cleanse the colon prior to colonoscopy in adults. The review describes the product composition, dilution approach, and studied dosing regimens, including the split-dose schedule and the same-day/evening-only regimen. The central review issue focuses on whether submitted data adequately support safety and whether comparative safety claims versus phosphate-salt products are substantiated. Review disciplines recommended approval, while the CDTL raised concerns about incomplete safety profiling and supported further large studies; the Division Director concludes approval should proceed but the same-day/evening-only regimen should not be approved, with additional studies pursued post-marketing to support labeling updates.",{"@graph":14,"@context":77},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/document/","Document",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/document/healthcare/","Healthcare",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/document/suprep-bowel-prep-kit-division-director-summary-review-approval/403040/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/suprep-bowel-prep-kit-division-director-summary-review-approval/403040.png","ImageObject",300,407,{"name":42,"@type":43},"Rowan","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-11-04","2026-09-27",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",11,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69,73],{"name":60,"@type":61,"acceptedAnswer":62},"What product and indication are reviewed in this summary?","Question",{"text":63,"@type":64},"The NDA reviews SUPREP Bowel Prep Kit as a bowel cleanser prior to colonoscopy in adults. The stated proposed indication is cleansing the colon as preparation for colonoscopy in adults.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"What dosing regimen details are included for patient administration?",{"text":68,"@type":64},"The document describes a split-dose regimen where one 6 oz bottle is diluted, followed by additional water “cups,” and the sequence is repeated with the second bottle 12 hours later. It also discusses concerns related to the “same day/evening only” regimen.",{"name":70,"@type":61,"acceptedAnswer":71},"What was the main safety issue influencing the regulatory discussion?",{"text":72,"@type":64},"The major review issue is whether the submitted data adequately support the safety of this new product. The CDTL expressed concerns that safety had not been adequately studied to determine the full safety profile.",{"name":74,"@type":61,"acceptedAnswer":75},"What is the Division Director’s final regulatory conclusion?",{"text":76,"@type":64},"The Division Director agrees with proceeding with approval but concludes the “same day/evening only” regimen should not be approved. Additional safety studies are expected to support labeling updates as post-marketing required studies.","https://schema.org",{"og:url":32,"og:type":79,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":81,"canonical":32},"index,follow",{"doc_id":83,"site_id":7},403040,1790648468,{"code":4,"msg":86,"data":87},"success",[88,92,96,100,105,110,114,119,124,127,131],{"id":22,"doc_module":4,"doc_module_name":25,"category_name":89,"show_sort_weight":90,"slug":91},"Story & Novel",90,"story-novel",{"id":26,"doc_module":4,"doc_module_name":25,"category_name":93,"show_sort_weight":94,"slug":95},"Literature",80,"literature",{"id":33,"doc_module":4,"doc_module_name":25,"category_name":97,"show_sort_weight":98,"slug":99},"Exam",70,"exam",{"id":101,"doc_module":4,"doc_module_name":25,"category_name":102,"show_sort_weight":103,"slug":104},5,"Comic",60,"comic",{"id":106,"doc_module":4,"doc_module_name":25,"category_name":107,"show_sort_weight":108,"slug":109},6,"Technology",50,"technology",{"id":111,"doc_module":4,"doc_module_name":25,"category_name":29,"show_sort_weight":112,"slug":113},7,40,"healthcare",{"id":115,"doc_module":4,"doc_module_name":25,"category_name":116,"show_sort_weight":117,"slug":118},8,"Research & Report",30,"research-report",{"id":120,"doc_module":4,"doc_module_name":25,"category_name":121,"show_sort_weight":122,"slug":123},9,"Religion & Spirituality",20,"religion-spirituality",{"id":122,"doc_module":4,"doc_module_name":25,"category_name":125,"show_sort_weight":122,"slug":126},"World Cup","world-cup",{"id":128,"doc_module":4,"doc_module_name":25,"category_name":129,"show_sort_weight":128,"slug":130},10,"Lifestyle","lifestyle",{"id":132,"doc_module":4,"doc_module_name":25,"category_name":133,"show_sort_weight":101,"slug":134},19,"General","general",{"code":4,"msg":86,"data":136},{"doc_id":83,"user_id":137,"nickname":42,"user_avatar":138,"doc_module":4,"category_id":111,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":139,"file_id":140,"file_url":141,"file_type":142,"file_size":143,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":144,"language":145,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":146,"faqs":147,"seo_title":148,"seo_description":12,"update_tm":149,"read_time":150,"preview_page_count":4},1099514067415,"https://ap-avatar.wpscdn.com/avatar/100002539d78ffe74a7?x-image-process=image/resize,m_fixed,w_180,h_180&k=1779092875211072502","CENTER FOR DRUG EVALUATION AND  \nRESEARCH  \nAPPLICATION NUMBER:  \n022372Orig1s000  \nSUMMARY REVIEW  \nDivision Director Review  \nSummary Review for Regulatory Action  \n\n| Date | August 5, 2010 |\n| --- | --- |\n| From | Donna Griebel, MD |\n| Subject | Division Director Summary Review |\n| NDA\\# | 022372 |\n| Applicant Name | Braintree Laboratories, Inc |\n| Date of Submission | July 1, 2008 |\n| PDUFA Goal Date | August 2, 2009 (initially May 2, 2009; however, clock was extended 3 months due to submission of major amendment) |\n| Proprietary Name /\u003Cbr>Established (USAN) Name | SUPREP Bowel Prep Kit/\u003Cbr>(sodium sulfate, potassium sulfate, magnesium sulfate) Oral solution |\n| Dosage Forms / Strength | Liquid concentrate of sodium sulfate, USP (17.51g), potassium sulfate, FCC (3.13g), magnesium sulfate anhydrous, USP (1.6g) in 170.41 g water per 6 oz bottle |\n| Proposed Indication(s) | Cleansing of the colon as a preparation for colonoscopy in adults |\n| Action | Approval |\n\n\n| Material Reviewed/Consulted\u003Cbr>OND Action Package, including: | Names of discipline reviewers |\n| --- | --- |\n| Medical Officer Review | Jasmine Gatti, MD |\n| Statistical Review | Milton Fan, PhD/Mike Welch, PhD\u003Cbr>Benjamin B. Neustifter, PhD/Antonio Paredes, MA, MS/ Aloka Chakravarty, PhD |\n| Pharmacology Toxicology Review | Tamal Chakraborti, PhD/Sushanta Chakder, PharmD |\n| CMC Review/OBP Review | Tarun Mehta, PhD/Marie Kowblansky, PhD |\n| Clinical Pharmacology Review | Jane Bai, PhD/Sue-Chih Lee, PhD |\n| DDMAC | Shefali Doshi |\n| DSI | Khairy Malek, MD\u003Cbr>Constance Lewin, M.D, MPH |\n| CDTL Review | John Hyde, PhD, MD |\n| OSE/DMEPA | Anne Crandall, PharmD |\n| OSE/DRISK | Melissa Hulett, MSBA, BSN, RN\u003Cbr>Shawna Hutchins, MPH, BSN, RN\u003Cbr>Barbara Fuller, RN, MSN |\n| Division of Cardiovascular and Renal Products | Melanie Blank, MD/Norman L Stockbridge, MD, PhD |\n| Office of Pharmaceutical Science | Vinayak. B. Pawar, Ph.D. |\n\nOND=Office of New Drugs  \nDDMAC=Division of Drug Marketing, Advertising and Communication  \nDivision Director Review  \nOSE= Office of Surveillance and Epidemiology DMEPA=Division of Medication Errors Prevention and Analysis DSI=Division of Scientific Investigations  \nDRISK= Division of Risk Management  \nDSRCS=Division of Surveillance, Research, and Communication Support CDTL=Cross-Discipline Team Leader  \nDivision Director Review  \n1. Introduction  \nThe applicant proposes Suprep Bowel Prep Kit for use as a bowel cleanser prior to colonoscopy. It consists of a carton that contains two equal doses (6 oz) of 17.5 g sodium sulfate, 3.13 g potassium sulfate and 1.6 g magnesium sulfate in each of the 6 oz bottles. The  \nbottled solutions are further diluted before the patient drinks them. The applicant proposes dose schedules, studied in phase 3 clinical trials. In the “Split dose”  \nregimen the patient dilutes the contents of one of the 6 oz bottles to 16 oz, drinks the diluted solution and follows with two additional 16 oz “cups” of water  \n . The sequence is then repeated with the second 6 oz bottle, 12 hours after the first dose.  \n(b) (4)  \n(b) (4)  \n(b) (4)  \n(b) (4)  \n(b) (4)  \nThe proposed product is a cathartic agent that produces its effect by exposure of the bowel lumen to a hyperosmolar solution. There are other approved hyperosmolar solution products available, including oral sodium phosphate products. (See summary in Section 2 Background below.) In addition there are combination products of salts combined with polyethylene glycol (PEG) . Suprep is unique in that it contains no phosphate salts. The osmotic ions in Suprep are all in sulfate form. The phosphate salt products have been the subject of class labeling for renal impairment. Recently the Division has required that the manufacturers of phosphate salt products conduct a safety study to evaluate the risk of developing acute kidney injury inpatients undergoing bowel cleansing. (See Background Section below.) The applicant proposes that Suprep will be a safer bowel prep product bec","cbCaih61NHSsW5zf","https://ap.wps.com/l/cbCaih61NHSsW5zf","pdf",825608,67,"English","# 1. Introduction\n## Proposed product and dosing regimens\n## Background on hyperosmolar and phosphate-salt products\n## Major review issue and safety conclusions","[{\"question\":\"What product and indication are reviewed in this summary?\",\"answer\":\"The NDA reviews SUPREP Bowel Prep Kit as a bowel cleanser prior to colonoscopy in adults. The stated proposed indication is cleansing the colon as preparation for colonoscopy in adults.\"},{\"question\":\"What dosing regimen details are included for patient administration?\",\"answer\":\"The document describes a split-dose regimen where one 6 oz bottle is diluted, followed by additional water “cups,” and the sequence is repeated with the second bottle 12 hours later. It also discusses concerns related to the “same day/evening only” regimen.\"},{\"question\":\"What was the main safety issue influencing the regulatory discussion?\",\"answer\":\"The major review issue is whether the submitted data adequately support the safety of this new product. The CDTL expressed concerns that safety had not been adequately studied to determine the full safety profile.\"},{\"question\":\"What is the Division Director’s final regulatory conclusion?\",\"answer\":\"The Division Director agrees with proceeding with approval but concludes the “same day/evening only” regimen should not be approved. Additional safety studies are expected to support labeling updates as post-marketing required studies.\"}]","SUPREP Bowel Prep Kit - Division Director Summary Review - Approval | PDF",1790536825,169]