{"id":7410,"date":"2010-05-06T14:15:43","date_gmt":"2010-05-06T18:15:43","guid":{"rendered":"http:\/\/asweetlife.org\/?p=7410"},"modified":"2015-12-28T07:38:48","modified_gmt":"2015-12-28T12:38:48","slug":"fda-classifies-bydureon-complete-response-as-a-class-2-resubmission","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=7410","title":{"rendered":"FDA Classifies Bydureon Complete Response as a Class 2 Resubmission"},"content":{"rendered":"

\"\"<\/a>Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. announced that the U.S. Food and Drug Administration has classified the Bydureon(TM) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010.<\/p>\n

Bydureon (pronounced by-DUR-ee-on) is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide – the active ingredient in Byetta – in a single weekly dose.\u00a0 Byetta, the first FDA-approved GLP-1 receptor agonist for the treatment of type 2 diabetes, has been available in the U.S. since June 2005 and is used in approximately 60 countries worldwide to improve glycemic control in adults with type 2 diabetes.<\/p>\n","protected":false},"excerpt":{"rendered":"

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. announced that the U.S. Food and Drug Administration has classified the Bydureon(TM) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010…<\/p>\n","protected":false},"author":131,"featured_media":29440,"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":[1443],"tags":[671,277],"yoast_head":"\nFDA Classifies, Type 2 Drug, Bydureon Complete Response as a Class 2 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