{"id":31966,"date":"2013-02-11T06:52:43","date_gmt":"2013-02-11T11:52:43","guid":{"rendered":"http:\/\/asweetlife.org\/?post_type=news&#038;p=31966"},"modified":"2015-12-29T08:53:09","modified_gmt":"2015-12-29T13:53:09","slug":"fda-delays-review-of-novo-nordisks-new-drug-applications-for-tresiba-and-ryzodeg","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=31966","title":{"rendered":"FDA Delays Review of Novo Nordisk&#8217;s New Drug Applications for Tresiba and Ryzodeg"},"content":{"rendered":"<div style=\"text-align: justify;\"><a href=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2013\/02\/Novo-Nordisk-Logo.png\" rel=\"mfp\"><img decoding=\"async\" class=\"size-full wp-image-31967 alignleft lazyload\" title=\"Novo Nordisk Logo\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2013\/02\/Novo-Nordisk-Logo.png\" alt=\"\" width=\"215\" height=\"160\" \/><\/a>The U.S. FDA issued a\u00a0Complete Response Letter regarding the New Drug Applications for Tresiba (insulin degludec) and Ryzodeg (insulin degludec\/insulin aspart) informing Novo Nordisk that an application cannot be approved in its current form.<\/div>\n<div style=\"text-align: justify;\">\u00a0<\/div>\n<div style=\"text-align: justify;\">In the letter, the FDA requests additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the New Drug Applications can be completed. Novo Nordisk is evaluating the content of the Complete Response Letter and will work closely with the FDA to provide the requested data. Novo Nordisk does not expect to be able to provide the requested data during\u00a02013.<\/p>\n<p>The FDA also states that approvals for Tresiba and Ryzodeg cannot be granted until the violations cited in the previously announced Warning Letter, dated 12 December\u00a02012, have been resolved.<\/p>\n<p>The New Drug Applications for Tresiba and Ryzodeg were submitted by Novo Nordisk to the FDA in September\u00a02011. In November\u00a02012, at an FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting, a panel of independent scientific experts unanimously recommended that a cardiovascular outcomes trial should be conducted and voted eight to four in favor of approving the products with a post-approval cardiovascular outcomes trial commitment.<\/p>\n<p>Tresiba and Ryzodeg were\u00a0<a href=\"https:\/\/asweetlife.org\/news\/novo-nordisks-combination-insulin-ryzodeg-approved-in-japan\/\" target=\"_blank\">approved in Japan<\/a>, the\u00a0<a href=\"https:\/\/asweetlife.org\/news\/novo-nordisks-new-insulins-tresiba-and-ryzodeg-approved-by-eu\/\" target=\"_blank\">EU<\/a>\u00a0and Mexico and are under regulatory review in a number of countries throughout the world.<\/p>\n<p>The Complete Response Letter is not expected to significantly impact Novo Nordisk&#8217;s expectations for the company&#8217;s financial results for\u00a02013, which were provided on 31 January\u00a02013\u00a0in connection with the release of the financial results for\u00a02012.<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. FDA issued a Complete Response Letter regarding the New Drug Applications for Tresiba (insulin degludec) and Ryzodeg (insulin degludec\/insulin aspart) informing Novo Nordisk that an application cannot be approved in its current form.<\/p>\n","protected":false},"author":131,"featured_media":31967,"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":[135,1276,1257],"yoast_head":"<!-- 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