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The package also fulfills related postmarketing requirement commitments and includes administrative approval, labeling content submissions in SPL format, and pediatric assessment obligations under PREA.",{"@graph":14,"@context":73},[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/approval-package-for-nda-215256s-011-wegovy-semaglutide/402666/",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/approval-package-for-nda-215256s-011-wegovy-semaglutide/402666.png","ImageObject",300,407,{"name":42,"@type":43},"Cipher","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-10-29","2026-09-27",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",8,{"@type":57,"mainEntity":58},"FAQPage",[59,65,69],{"name":60,"@type":61,"acceptedAnswer":62},"What supplemental indication was added for Wegovy (semaglutide) injection?","Question",{"text":63,"@type":64},"Wegovy was indicated, with a reduced calorie diet and increased physical activity, to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight.","Answer",{"name":66,"@type":61,"acceptedAnswer":67},"Which trial supported the added indication?",{"text":68,"@type":64},"The indication addition was based on trial EX9536-4388 titled “SELECT - Semaglutide effects on cardiovascular outcomes in people with overweight or obesity.”",{"name":70,"@type":61,"acceptedAnswer":71},"What labeling and submission steps were required after approval?",{"text":72,"@type":64},"Within 14 days, the sponsor must submit content of labeling in structured product labeling (SPL) format via eLIST and amend pending supplemental applications with labeling changes, including providing highlighted or marked-up and clean Word versions.","https://schema.org",{"og:url":32,"og:type":75,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":77,"canonical":32},"index,follow",{"doc_id":79,"site_id":7},402666,1790754637,{"code":4,"msg":82,"data":83},"success",[84,88,92,96,101,106,110,114,119,122,126],{"id":22,"doc_module":4,"doc_module_name":25,"category_name":85,"show_sort_weight":86,"slug":87},"Story & Novel",90,"story-novel",{"id":26,"doc_module":4,"doc_module_name":25,"category_name":89,"show_sort_weight":90,"slug":91},"Literature",80,"literature",{"id":33,"doc_module":4,"doc_module_name":25,"category_name":93,"show_sort_weight":94,"slug":95},"Exam",70,"exam",{"id":97,"doc_module":4,"doc_module_name":25,"category_name":98,"show_sort_weight":99,"slug":100},5,"Comic",60,"comic",{"id":102,"doc_module":4,"doc_module_name":25,"category_name":103,"show_sort_weight":104,"slug":105},6,"Technology",50,"technology",{"id":107,"doc_module":4,"doc_module_name":25,"category_name":29,"show_sort_weight":108,"slug":109},7,40,"healthcare",{"id":55,"doc_module":4,"doc_module_name":25,"category_name":111,"show_sort_weight":112,"slug":113},"Research & Report",30,"research-report",{"id":115,"doc_module":4,"doc_module_name":25,"category_name":116,"show_sort_weight":117,"slug":118},9,"Religion & Spirituality",20,"religion-spirituality",{"id":117,"doc_module":4,"doc_module_name":25,"category_name":120,"show_sort_weight":117,"slug":121},"World Cup","world-cup",{"id":123,"doc_module":4,"doc_module_name":25,"category_name":124,"show_sort_weight":123,"slug":125},10,"Lifestyle","lifestyle",{"id":127,"doc_module":4,"doc_module_name":25,"category_name":128,"show_sort_weight":97,"slug":129},19,"General","general",{"code":4,"msg":82,"data":131},{"doc_id":79,"user_id":132,"nickname":42,"user_avatar":133,"doc_module":4,"category_id":107,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":39,"language":139,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":12,"update_tm":143,"read_time":144,"preview_page_count":4},687208528416,"https://ap-avatar.wpscdn.com/davatar_9964176cb1d06d4a9deccf72a44ae3dc","CENTER FOR DRUG EVALUATION AND RESEARCH  \nApproval Package for:  \nAPPLICATION NUMBER:  \n215256Orig1s011  \nTrade Name: WEGOVY  \nGeneric or Proper semaglutide  \nName:  \nSponsor: Novo Nordisk Inc.  \nApproval Date: March 8, 2024  \nIndication:  \nWEGOVY is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated in combination with a reduced calorie diet and increased physical activity:  \n• to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight.  \n• to reduce excess body weight and maintain weight reduction long term in:  \n• Adults and pediatric patients aged 12 years and older with obesity  \n• Adults with overweight in the presence of at least one weight-related comorbid condition.  \nCENTER FOR DRUG EVALUATION AND RESEARCH  \n215256Orig1s011  \nCONTENTS  \nReviews / Information Included in this NDA Review.  \n\n| Approval Letter | X |\n| --- | --- |\n| Other Action Letters |  |\n| Labeling | X |\n| REMS |  |\n| Summary Review |  |\n| Officer/Employee List |  |\n| Office Director Memo |  |\n| Cross Discipline Team Leader Review |  |\n| Clinical Review(s) | X |\n| Product Quality Review(s) |  |\n| Non-Clinical Review(s) |  |\n| Statistical Review(s) | X |\n| Clinical Microbiology / Virology Review(s) |  |\n| Clinical Pharmacology Review(s) |  |\n| Other Reviews | X |\n| Risk Assessment and Risk Mitigation Review(s) |  |\n| Proprietary Name Review(s) |  |\n| Administrative/Correspondence Document(s) |  |\n\nCENTER FOR DRUG EVALUATION AND  \nRESEARCH  \nAPPLICATION NUMBER:  \n215256Orig1s011  \nAPPROVAL LETTER  \nNDA 215256/S-011  \nSUPPLEMENT APPROVAL  \nFULFILLMENT OF POSTMARKETING REQUIREMENT(S)  \nNovo Nordisk Inc.  \nAttention: Stephanie DeChiaro  \nExecutive Director, Regulatory Affairs  \nP.O. Box 846  \n800 Scudders Mill Road Plainsboro, NJ 08536  \nDear Stephanie DeChiaro:  \nPlease refer to your supplemental new drug application (sNDA) dated and received September 8, 2023 , and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Wegovy (semaglutide) injection.  \nThis Prior Approval sNDA provides for the addition of the following indication to the Prescribing Information , with corresponding revisions to the Medication Guide:  \n• Wegovy is indicated in combination with a reduced calorie diet and increased physical activity to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight.  \nThe addition of this indication is based on the result from trial EX9536-4388 , entitled“SELECT − Semaglutide effects on cardiovascular outcomes in people with overweight or obesity.” This trial also addresses the following postmarketing requirement listed in the June 4, 2021 , approval letter:  \n4081-6: Complete the ongoing randomized, double-blind, parallel-group, placebo-controlled trial in approximately 17,500 patients with established CV disease and overweight or obesity (randomized 1:1 to semaglutide 2.4 mg and placebo) to evaluate the long-term effects of semaglutide 2.4 mg on pancreatitis, gallbladder disorders, renal safety, serious hepatic events, malignant neoplasms, serious hypoglycemia, and serious gastrointestinal disorders.  \nAPPROVAL & LABELING  \nNDA 215256/S-011  \nPage 2  \nWe have completed our review of this application, as amended. It is approved , effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling with minor editorial revisions listed below and reflected in the enclosed labeling.  \n• A vertical line has been added to the left edge of the indication statements.  \nWAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS  \nPlease note that we have previously granted a waiver of the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of Pres","cbCaipWJh2c1XDKG","https://ap.wps.com/l/cbCaipWJh2c1XDKG","pdf",21154472,"English","# Approval Letter\n## Supplement Approval (NDA 215256/S-011)\n## Fulfillment of Postmarketing Requirement(s)\n## Approval & Labeling\n## Waiver of 1/2 Page Length Requirement for Highlights\n## Content of Labeling\n## Required Pediatric Assessments","[{\"question\":\"What supplemental indication was added for Wegovy (semaglutide) injection?\",\"answer\":\"Wegovy was indicated, with a reduced calorie diet and increased physical activity, to reduce the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight.\"},{\"question\":\"Which trial supported the added indication?\",\"answer\":\"The indication addition was based on trial EX9536-4388 titled “SELECT - Semaglutide effects on cardiovascular outcomes in people with overweight or obesity.”\"},{\"question\":\"What labeling and submission steps were required after approval?\",\"answer\":\"Within 14 days, the sponsor must submit content of labeling in structured product labeling (SPL) format via eLIST and amend pending supplemental applications with labeling changes, including providing highlighted or marked-up and clean Word versions.\"}]","Approval Package for - NDA 215256/S-011 - Wegovy (semaglutide) | PDF",1790532496,756]