{"id":1485,"date":"2010-03-30T18:08:57","date_gmt":"2010-03-30T22:08:57","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/%e2%80%a2-fda-issues-complete-response-letter-for-certriad%e2%80%a2-u-k-s-nice-goes-easier-on-dronedarone%e2%80%a2-u-s-justice-dept-sec-look-into-boston-scientific-icd-recall\/"},"modified":"2011-07-19T17:45:00","modified_gmt":"2011-07-19T21:45:00","slug":"%e2%80%a2-fda-issues-complete-response-letter-for-certriad%e2%80%a2-u-k-s-nice-goes-easier-on-dronedarone%e2%80%a2-u-s-justice-dept-sec-look-into-boston-scientific-icd-recall","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2010\/03\/30\/%e2%80%a2-fda-issues-complete-response-letter-for-certriad%e2%80%a2-u-k-s-nice-goes-easier-on-dronedarone%e2%80%a2-u-s-justice-dept-sec-look-into-boston-scientific-icd-recall\/","title":{"rendered":"\u2022 FDA Issues Complete Response Letter For Certriad<br \/>\u2022 U.K.\u2019s NICE Goes Easier on Dronedarone<br \/>\u2022 U.S. Justice Dep\u2019t &#038; SEC Look Into Boston Scientific ICD Recall"},"content":{"rendered":"<p><strong>FDA Issues Complete Response Letter For Certriad:<\/strong> The FDA issued a complete response letter for the NDA for Certriad, Abbot&#8217;s and AstraZeneca&#8217;s combination pill composed of rosuvastatin and fenofibric acid delayed release. The companies did not release any details of the letter, but analysts think it will mean the drug&#8217;s approval will likely be delayed until next year\u00a0at least. (<a href=\"http:\/\/www.prnewswire.com\/news-releases\/astrazeneca-and-abbott-receive-fda-complete-response-letter-on-certriadtm-new-drug-application-89501242.html\">Press release<\/a>.)<strong><\/p>\n<p>U.K.&#8217;s NICE Goes Easier on Dronedarone:<\/strong> Following an earlier negative recommendation, the U.K.&#8217;s\u00a0National Institute for Health and Clinical Excellence has revised its preliminary recommendations for dronedarone. The new draft guidance recommends the use of the drug only as a second-line therapy in high-risk AF patients without unstable NYHA class III or class IV heart failure. (<a href=\"http:\/\/www.nice.org.uk\/guidance\/index.jsp?action=article&amp;o=48099\">NICE appraisal consultation document<\/a>.)<\/p>\n<p><strong>U.S. Justice Dep&#8217;t &amp; SEC Look Into Boston Scientific ICD Recall: <\/strong><a href=\"http:\/\/online.wsj.com\/article\/SB10001424052702304370304575151760074891360.html?mg=com-wsj\">The Wall Street Journal reports<\/a>\u00a0(subscription required) that the U.S. Department of Justice and the Securities and Exchange Commission are each undertaking an investigation of Boston Scientific&#8217;s recent recall of its ICDs. On Monday, the company released <a href=\"http:\/\/ccbn.10kwizard.com\/xml\/download.php?repo=tenk&amp;ipage=6857426&amp;format=PDF\">a transcript of a conference call<\/a> with physicians in which the company explained the recall and provided assurances about the company&#8217;s future.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA Issues Complete Response Letter For Certriad: The FDA issued a complete response letter for the NDA for Certriad, Abbot&#8217;s and AstraZeneca&#8217;s combination pill composed of rosuvastatin and fenofibric acid delayed release. The companies did not release any details of the letter, but analysts think it will mean the drug&#8217;s approval will likely be delayed [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-1485","post","type-post","status-publish","format-standard","hentry","category-general"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/1485","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=1485"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/1485\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=1485"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=1485"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=1485"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}