{"id":3392,"date":"2010-09-20T17:13:05","date_gmt":"2010-09-20T21:13:05","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=3392"},"modified":"2011-07-19T17:44:48","modified_gmt":"2011-07-19T21:44:48","slug":"fda-panel-unanimously-recommends-approval-for-dabigatran","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2010\/09\/20\/fda-panel-unanimously-recommends-approval-for-dabigatran\/","title":{"rendered":"FDA Panel Unanimously Recommends Approval for Dabigatran"},"content":{"rendered":"<p>The FDA&#8217;s\u00a0Cardiovascular and Renal Drugs Advisory Committee voted 9-0 in favor of approval of \u00a0dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The panel was split on whether both dosages (150 mg bid and 110 mg bid) used in the RE-LY trial should gain approval, although in an informal straw poll, a majority appeared to favor approval for both dosages. (The FDA reviewers had recommended approval for only the higher dosage.)\u00a0Most panel members also supported language on the label summarizing the superiority of the 150 mg dose over warfarin in RE-LY.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA&#8217;s\u00a0Cardiovascular and Renal Drugs Advisory Committee voted 9-0 in favor of approval of \u00a0dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The panel was split on whether both dosages (150 mg bid and 110 mg bid) used in the RE-LY trial should gain approval, although in an informal straw [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13,7],"tags":[339,196,422,342],"class_list":["post-3392","post","type-post","status-publish","format-standard","hentry","category-electrophysiology","category-prevention","tag-dabigatran","tag-fda","tag-pradaxa","tag-spaf"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/3392","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/196"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=3392"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/3392\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=3392"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=3392"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=3392"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}