{"id":2163,"date":"2010-07-23T12:49:53","date_gmt":"2010-07-23T16:49:53","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?p=2163"},"modified":"2011-07-19T17:44:55","modified_gmt":"2011-07-19T21:44:55","slug":"fda-approves-generic-enoxaparin","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2010\/07\/23\/fda-approves-generic-enoxaparin\/","title":{"rendered":"FDA Approves Generic Enoxaparin"},"content":{"rendered":"<p>The FDA announced on Friday that it had approved the first generic enoxaparin sodium injection for multiple indications including prevention of\u00a0deep vein thrombosis  (DVT). The action represents the FDA&#8217;s first generic approval of a low molecular weight heparin. The original version of enoxaparin, Lovenox, was first approved in 1993. To gain approval as a generic, the FDA required its manufacturer, Sandoz, to perform &#8220;a series of sophisticated analytical tests and a study in healthy volunteers to\u00a0assure\u00a0that the drug\u00a0would be as safe and effective as the brand name product,&#8221; said an FDA official in a <a href=\"http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm220092.htm\">press release<\/a>. More information about the approval is available on <a href=\"http:\/\/www.fda.gov\/Drugs\/DrugSafety\/PostmarketDrugSafetyInformationforPatientsandProviders\/ucm220018.htm\">the FDA website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA announced on Friday that it had approved the first generic enoxaparin sodium injection for multiple indications including prevention of\u00a0deep vein thrombosis (DVT). The action represents the FDA&#8217;s first generic approval of a low molecular weight heparin. The original version of enoxaparin, Lovenox, was first approved in 1993. To gain approval as a generic, [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,7],"tags":[220,196,222,223,219,221],"class_list":["post-2163","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention","tag-enoxaparin","tag-fda","tag-fda-approvals","tag-generics","tag-lovenox","tag-low-molecular-weight-heparin"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/2163","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=2163"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/2163\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=2163"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=2163"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=2163"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}