{"id":28776,"date":"2015-08-01T09:06:30","date_gmt":"2015-08-01T09:06:30","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=28776"},"modified":"2015-08-10T11:41:29","modified_gmt":"2015-08-10T11:41:29","slug":"rilpivirineftctaf-becomes-the-third-taf-based-fixed-dose-combination-submitted-for-us-approval","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/28776","title":{"rendered":"Rilpivirine\/FTC\/TAF becomes the third TAF-based fixed dose combination submitted for US approval"},"content":{"rendered":"<p><strong>Simon Collins, HIV i-Base<\/strong><\/p>\n<p><strong>On 1 July 2015, Gilead submitted a new drug application to the US FDA for a fixed dose combination tablet that contains rilpivirine, FTC and tenofovir alafenamide fumerate (TAF).<\/strong> [1]<\/p>\n<p>As a priority review, the FDA decision is expected within six months of the filing.<\/p>\n<p>This is the third filing that includes the new TAF formulation of tenofovir. The FDA dates for the two previous submissions are 5 November 2015 for elviregravir\/cobicistat\/FTC\/TAF (E\/C\/F\/TAF) and 7 April 2016 for the dual formulation of FTC\/TAF (F\/TAF).<\/p>\n<p>Applications in the European Union (EU) were validated on 23 December 2014 for E\/C\/F\/TAF and on 28 May 2015 for F\/TAF. The EU application for R\/F\/TAF is due to be filed in the third quarter of 2015.<\/p>\n<p>Reference:<\/p>\n<p>Gilead press statement. Gilead submits new drug application to U.S. Food and Drug Administration for single tablet regimen for HIV containing rilpivirine, emtricitabine and tenofovir alafenamide (R\/F\/TAF). (01 July 2015).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Simon Collins, HIV i-Base On 1 July 2015, Gilead submitted a new drug application to the US FDA for a fixed dose combination tablet that contains rilpivirine, FTC and tenofovir alafenamide fumerate (TAF). [1] As a priority review, the FDA &hellip;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-28776","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/28776","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=28776"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/28776\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=28776"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=28776"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=28776"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}