{"id":14798,"date":"2023-08-22T10:35:00","date_gmt":"2023-08-22T02:35:00","guid":{"rendered":"https:\/\/flcube.com\/?p=14798"},"modified":"2024-11-25T10:42:18","modified_gmt":"2024-11-25T02:42:18","slug":"auzone-biological-technology-gets-fda-approval-for-edaravone-oral-preparations-in-als","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=14798","title":{"rendered":"Auzone Biological Technology Gets FDA Approval for Edaravone Oral Preparations in ALS"},"content":{"rendered":"\n<p>Suzhou Auzone Biological Technology Co., Ltd. has received approval from the US Food and Drug Administration (FDA) to initiate a pivotal clinical study for its edaravone oral preparations in the treatment of amyotrophic lateral sclerosis (ALS). The Chinese company, which has a wholly owned subsidiary in Australia, is planning to file a New Drug Application (NDA) for the drug with the FDA in March of the following year.<\/p>\n\n\n\n<p><strong>Edaravone&#8217;s Background and Auzone Bio&#8217;s Advantages<\/strong><br>Edaravone, a hydroxyl radical scavenger, was originally developed by Japan-based Mitsubishi Tanabe Pharma Corporation. It was first approved in Japan in June 2015 and subsequently gained marketing approval in the US in May 2017 and in China in August 2019. Auzone Bio sees its oral preparations as more advantageous compared to the original injectable form and other generic versions, which are predominantly injections. The company highlights the benefits of its oral preparations in terms of administration convenience and patient compliance.<a href=\"https:\/\/flcube.com\">-Fineline Info &amp; Tech<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Suzhou Auzone Biological Technology Co., Ltd. has received approval from the US Food and Drug&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[2323,62,31,24],"class_list":["post-14798","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-auzone-biological-technology","tag-clinical-trial-approval-initiation","tag-generic-drugs","tag-rare-orphan-disease-drugs"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Auzone Biological Technology Gets FDA Approval for Edaravone Oral Preparations in ALS - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Suzhou Auzone Biological Technology Co., Ltd. has received approval from the US Food and Drug Administration (FDA) to initiate a pivotal clinical study for its edaravone oral preparations in the treatment of amyotrophic lateral sclerosis (ALS). The Chinese company, which has a wholly owned subsidiary in Australia, is planning to file a New Drug Application (NDA) for the drug with the FDA in March of the following year.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=14798\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Auzone Biological Technology Gets FDA Approval for Edaravone Oral Preparations in ALS\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=14798\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2023-08-22T02:35:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-25T02:42:18+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14798#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14798\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Auzone Biological Technology Gets FDA Approval for Edaravone Oral Preparations in ALS\",\"datePublished\":\"2023-08-22T02:35:00+00:00\",\"dateModified\":\"2024-11-25T02:42:18+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14798\"},\"wordCount\":169,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Auzone Biological Technology\",\"Clinical trial approval \\\/ initiation\",\"Generic drugs\",\"Rare \\\/ orphan disease drugs\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=14798#respond\"]}],\"copyrightYear\":\"2023\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14798\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=14798\",\"name\":\"Auzone Biological Technology Gets FDA Approval for Edaravone Oral Preparations in ALS - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2023-08-22T02:35:00+00:00\",\"dateModified\":\"2024-11-25T02:42:18+00:00\",\"description\":\"Suzhou Auzone Biological Technology Co., Ltd. has received approval from the US Food and Drug Administration (FDA) to initiate a pivotal clinical study for its edaravone oral preparations in the treatment of amyotrophic lateral sclerosis (ALS). The Chinese company, which has a wholly owned subsidiary in Australia, is planning to file a New Drug Application (NDA) for the drug with the FDA in March of the following year.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14798#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=14798\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=14798#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Auzone Biological Technology Gets FDA Approval for Edaravone Oral Preparations in ALS\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"name\":\"Insight, China's Pharmaceutical Industry\",\"description\":\"Fineline Insights, Pharma Clarity\",\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/flcube.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\",\"name\":\"Fineline Infomation and Technology\",\"alternateName\":\"Fineline Info & Tech\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"width\":2560,\"height\":1894,\"caption\":\"Fineline Infomation and Technology\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/profile.php?id=61566606313834\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\",\"name\":\"Fineline Cube\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"caption\":\"Fineline Cube\"},\"sameAs\":[\"https:\\\/\\\/flcube.com\"],\"url\":\"https:\\\/\\\/flcube.com\\\/?author=1\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Auzone Biological Technology Gets FDA Approval for Edaravone Oral Preparations in ALS - Insight, China&#039;s Pharmaceutical Industry","description":"Suzhou Auzone Biological Technology Co., Ltd. has received approval from the US Food and Drug Administration (FDA) to initiate a pivotal clinical study for its edaravone oral preparations in the treatment of amyotrophic lateral sclerosis (ALS). The Chinese company, which has a wholly owned subsidiary in Australia, is planning to file a New Drug Application (NDA) for the drug with the FDA in March of the following year.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/flcube.com\/?p=14798","og_locale":"en_US","og_type":"article","og_title":"Auzone Biological Technology Gets FDA Approval for Edaravone Oral Preparations in ALS","og_description":"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM","og_url":"https:\/\/flcube.com\/?p=14798","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2023-08-22T02:35:00+00:00","article_modified_time":"2024-11-25T02:42:18+00:00","og_image":[{"width":2560,"height":1894,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","type":"image\/jpeg"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=14798#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=14798"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Auzone Biological Technology Gets FDA Approval for Edaravone Oral Preparations in ALS","datePublished":"2023-08-22T02:35:00+00:00","dateModified":"2024-11-25T02:42:18+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=14798"},"wordCount":169,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Auzone Biological Technology","Clinical trial approval \/ initiation","Generic drugs","Rare \/ orphan disease drugs"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=14798#respond"]}],"copyrightYear":"2023","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=14798","url":"https:\/\/flcube.com\/?p=14798","name":"Auzone Biological Technology Gets FDA Approval for Edaravone Oral Preparations in ALS - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2023-08-22T02:35:00+00:00","dateModified":"2024-11-25T02:42:18+00:00","description":"Suzhou Auzone Biological Technology Co., Ltd. has received approval from the US Food and Drug Administration (FDA) to initiate a pivotal clinical study for its edaravone oral preparations in the treatment of amyotrophic lateral sclerosis (ALS). The Chinese company, which has a wholly owned subsidiary in Australia, is planning to file a New Drug Application (NDA) for the drug with the FDA in March of the following year.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=14798#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=14798"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=14798#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Auzone Biological Technology Gets FDA Approval for Edaravone Oral Preparations in ALS"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/14798","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=14798"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/14798\/revisions"}],"predecessor-version":[{"id":14800,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/14798\/revisions\/14800"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=14798"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=14798"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=14798"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}