{"id":43442,"date":"2024-11-14T02:08:20","date_gmt":"2024-11-13T20:38:20","guid":{"rendered":"https:\/\/vajiramandravi.com\/current-affairs\/?p=43442"},"modified":"2025-05-06T02:38:25","modified_gmt":"2025-05-05T21:08:25","slug":"novo-nordisk-calls-for-fda-action-to-halt-compounded-versions-of-semaglutide-drugs","status":"publish","type":"post","link":"https:\/\/vajiramandravi.com\/current-affairs\/novo-nordisk-calls-for-fda-action-to-halt-compounded-versions-of-semaglutide-drugs\/","title":{"rendered":"Novo Nordisk Calls for FDA Action to Halt Compounded Versions of Semaglutide Drugs"},"content":{"rendered":"<h2><strong>What\u2019s in today\u2019s article?<\/strong><\/h2>\n<ul>\n<li>Why in News?<\/li>\n<li>Comparing Generic and Compounded Drugs<\/li>\n<li>Key Issues in Drug Compounding<\/li>\n<li>Proposed Solution to Address Issues with Drug Compounding<\/li>\n<\/ul>\n<h2><strong>Why in News?<\/strong><\/h2>\n<ul>\n<li>Novo Nordisk, the Danish pharmaceutical giant behind the popular drugs Wegovy (for weight loss) and Ozempic (to treat type 2 diabetes in adults), has requested that the U.S. Food and Drug Administration (FDA) stops the compounding of semaglutide-based medications.<\/li>\n<li>The company argues that compounded versions, created to meet rising demand, may pose safety risks to patients.<\/li>\n<\/ul>\n<h2><strong>Comparing Generic and Compounded Drugs:<\/strong><\/h2>\n<figure class=\"image image_resized\"><img decoding=\"async\" src=\"https:\/\/vajiram-prod.s3.ap-south-1.amazonaws.com\/Generic_v_Compounded_Drugs_2db3001911.webp\" alt=\"Generic v Compounded Drugs.webp\" \/><\/figure>\n<h2><strong>Key Issues in Drug Compounding:<\/strong><\/h2>\n<ul>\n<li><strong>Limited regulations:<\/strong>\n<ul>\n<li>Under FDA guidelines, <strong>licensed pharmacists can legally compound medications<\/strong> to meet patient needs, particularly when branded versions are unavailable.<\/li>\n<li>With Wegovy and Ozempic in high demand, compounding pharmacies have been formulating their own versions, <strong>prompting Novo Nordisk\u2019s intervention<\/strong>.<\/li>\n<li>American pharmaceutical firm <strong>Eli Lilly similarly sought to halt compounded versions<\/strong> of its drugs Mounjaro and Zepbound, intended for diabetes and obesity treatment.<\/li>\n<li><strong>The FDA has yet to issue a decision on either case.<\/strong>\n<ul>\n<li><strong>Purity risks: <\/strong>Semaglutide\u2019s intricate structure is challenging to replicate accurately. Hence, the compounded versions may lack precision, potentially compromising purity and stability.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/li>\n<li><strong>Risk of incorrect dosing:<\/strong>\n<ul>\n<li>The FDA-approved semaglutide is delivered through a single-use pen injector, ensuring precise dosage and clear usage instructions.<\/li>\n<li>Compounded drugs, however, are often dispensed in multi-dose vials or syringes, raising the risk of incorrect dosing.<\/li>\n<li>Reports cite patients <strong>accidentally overdosing<\/strong>, resulting in severe side effects like nausea and vomiting.<\/li>\n<\/ul>\n<\/li>\n<li><strong>Risking severe health issues:<\/strong>\n<ul>\n<li><strong>Bioavailability<\/strong> &#8211; the degree to which the drug reaches the bloodstream &#8211; is crucial for semaglutide.<\/li>\n<li>Without proper absorption, compounded versions may fail to provide the intended treatment effects, risking severe health issueslike <strong>heart disease, nerve damage, and kidney complications.<\/strong><\/li>\n<\/ul>\n<\/li>\n<li><strong>Contamination risks:<\/strong>\n<ul>\n<li>Compounded semaglutide requires <strong>sterile facilities and precise handling<\/strong> to avoid contamination.<\/li>\n<li>In recent years, the FDA has flagged sterility issues at compounding pharmacies, leading to significant recalls.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2><strong>Proposed Solution to Address Issues with Drug Compounding:<\/strong><\/h2>\n<ul>\n<li><strong>Adding Semaglutide to DDC list:<\/strong>\n<ul>\n<li>Novo Nordisk petitioned the FDA to place semaglutide on the Demonstrable Difficulties for Compounding (DDC) list, which would<strong> restrict its compounding when commercial options are available.<\/strong><\/li>\n<li>The FDA assesses drugs for the DDC list based on <strong>stability, bioavailability, dosage requirements, and sterility demands<\/strong>, all factors Novo Nordisk highlights in its case.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<hr \/>\n<h3><strong>Q.1. What are generic drugs?<\/strong><\/h3>\n<p>A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, colour, taste, and packaging.<\/p>\n<h3><strong>Q.2. Who regulates generic drugs in India?<\/strong><\/h3>\n<p>India&#8217;s regulatory landscape for generic drugs is governed by the Central Drugs Standard Control Organization (CDSCO), which operates under the Directorate General of Health Services, Ministry of Health and Family Welfare.<\/p>\n<p><strong>News:<\/strong> <a href=\"https:\/\/indianexpress.com\/article\/explained\/explained-health\/why-maker-of-magic-weight-loss-drug-semaglutide-wants-copies-banned-9668561\/\" target=\"_blank\" rel=\"nofollow noopener\">Why maker of \u2018magic\u2019 weightloss drug semaglutide wants copies banned<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Novo Nordisk, the Danish pharmaceutical giant behind the popular drugs Wegovy and Ozempic, has requested the U.S. FDA to stop the compounding of semaglutide-based medications<\/p>\n","protected":false},"author":5,"featured_media":43443,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[18],"tags":[],"class_list":{"0":"post-43442","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-upsc-mains-current-affairs","8":"no-featured-image-padding"},"acf":[],"_links":{"self":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/posts\/43442","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/comments?post=43442"}],"version-history":[{"count":0,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/posts\/43442\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/media\/43443"}],"wp:attachment":[{"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/media?parent=43442"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/categories?post=43442"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vajiramandravi.com\/current-affairs\/wp-json\/wp\/v2\/tags?post=43442"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}