{"id":36323,"date":"2014-07-08T06:10:10","date_gmt":"2014-07-08T10:10:10","guid":{"rendered":"http:\/\/asweetlife.org\/?post_type=news&#038;p=36323"},"modified":"2015-12-30T05:28:54","modified_gmt":"2015-12-30T10:28:54","slug":"fda-accepts-sanofis-nda-for-new-basal-insulin-toujeo","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=36323","title":{"rendered":"FDA Accepts Sanofi&#8217;s NDA for New Basal Insulin, Toujeo"},"content":{"rendered":"<p style=\"text-align: justify;\"><a href=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2014\/07\/sanofi-logo.jpg\" rel=\"mfp\"><img decoding=\"async\" class=\"alignleft size-full wp-image-36324 lazyload\" title=\"sanofi-logo\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2014\/07\/sanofi-logo.jpg\" alt=\"\" width=\"120\" height=\"86\" \/><\/a>The U.S. Food and Drug Administration (FDA) has accepted for review Sanofi\u2019s New Drug Application (NDA) for Toujeo (insulin glargine [rDNA origin] injection, 300 U\/mL), an investigational basal insulin. The acceptance of the NDA follows the acceptance of the marketing authorization dossier for Toujeo by the European Medicines Agency (EMA) for EU countries on May 27, 2014.\u00a0<\/p>\n<div>\n<div style=\"text-align: justify;\">\u00a0<\/div>\n<div style=\"text-align: justify;\">Toujeo is the trade name for insulin glargine [rDNA origin] injection, 300 U\/mL; formerly abbreviated as \u201cU300\u201d. Toujeo is an improved\u00a0version of Sanofi&#8217;s popular basal insulin, Lantus.<\/div>\n<div style=\"text-align: justify;\">\u00a0<\/div>\n<div style=\"text-align: justify;\">\n<div>The NDA for Toujeo is based on results from the EDITION clinical trial program, which is a worldwide and extensive series of Phase III studies evaluating the efficacy and safety of Toujeo in over 3,500 people from broad and diverse diabetes populations.\u00a0<\/div>\n<div>\u00a0<\/div>\n<\/div>\n<div style=\"text-align: justify;\">Sanofi expects the regulatory decision for marketing authorization for Toujeo in the U.S. in the first half of 2015.<\/div>\n<div style=\"text-align: justify;\">\u00a0<\/div>\n<div style=\"text-align: justify;\">Toujeo (U300) is not currently approved or licensed anywhere in the world.<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) has accepted for review Sanofi\u2019s New Drug Application (NDA) for Toujeo (insulin glargine [rDNA origin] injection, 300 U\/mL), an investigational basal insulin. The acceptance of the NDA follows the acceptance of the marketing authorization dossier for Toujeo by the European Medicines Agency (EMA) for EU countries on May 27, 2014. <\/p>\n","protected":false},"author":131,"featured_media":36324,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1441],"tags":[1351],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v22.9 (Yoast SEO v22.9) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA Accepts Sanofi&#039;s NDA for New Basal Insulin, 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