{"id":5935,"date":"2010-03-15T12:42:47","date_gmt":"2010-03-15T16:42:47","guid":{"rendered":"http:\/\/asweetlife.org\/?p=5935"},"modified":"2015-12-28T07:38:48","modified_gmt":"2015-12-28T12:38:48","slug":"amylin-lilly-and-alkermes-receive-fda-complete-response-letter-for-exenatide-once-weekly","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=5935","title":{"rendered":"Amylin, Lilly and Alkermes Receive FDA Complete Response Letter for Exenatide Once Weekly"},"content":{"rendered":"<p><a href=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2010\/03\/Amylin-Lilly-Logo1-1.png\" rel=\"mfp\"><img decoding=\"async\" class=\"alignleft size-full wp-image-5940 lazyload\" style=\"margin: 4px;\" title=\"Amylin Lilly Logo\" src=\"data:image\/gif;base64,R0lGODlhAQABAAAAACH5BAEKAAEALAAAAAABAAEAAAICTAEAOw==\" data-src=\"https:\/\/asweetlife.org\/wp-content\/uploads\/2010\/03\/Amylin-Lilly-Logo1-1.png\" alt=\"\" width=\"150\" height=\"44\" \/><\/a>Amylin Pharmaceuticals Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON(TM).<\/p>\n<p>In the complete response letter there are no requests for new pre-clinical or clinical trials. Requests raised in the letter primarily relate to the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes. The companies view this response as a positive step forward.<\/p>\n<p>BYDUREON 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 in a single weekly dose. BYDUREON is a once-weekly formulation of exenatide, the active ingredient in BYETTA<sup>(R)<\/sup> (exenatide) injection, which has been available in the U.S. since June 2005.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Amylin Pharmaceuticals Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON(TM).<br \/>\nIn the complete response letter there are no requests for new pre-clinical or clinical trials. Requests raised in the letter primarily relate to the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes. The companies view this response as a positive step forward&#8230;<\/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":[671,277,453,135],"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>Amylin, Lilly and Alkermes Receive FDA Complete Response Letter for Exenatide Once Weekly<\/title>\n<meta name=\"description\" content=\"Amylin 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