{"id":9608,"date":"2004-07-29T00:39:55","date_gmt":"2004-07-29T00:39:55","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=9608"},"modified":"2014-05-22T16:58:39","modified_gmt":"2014-05-22T16:58:39","slug":"tenofovirftc-co-formulation-expected-in-us-by-september","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/9608","title":{"rendered":"Tenofovir\/FTC co-formulation expected in US by September"},"content":{"rendered":"<p><strong>Gilead Sciences announced on May 17 that the US Food and Drug Administration (FDA) had granted priority review status to the New Drug Application (NDA) for the fixed dose co-formulation of the company\u2019s anti-HIV medications tenofovir (Viread) and FTC (emtricitabine, Emtriva).<\/strong><\/p>\n<p>Gilead submitted its application to the FDA on March 12, 2004 and had anticipated a decision by January 12, 2005 based on a 10-month traditional review. Under priority review, the NDA will be reviewed with in six months and the action date by which the FDA will make a decision is September 12, 2004.<\/p>\n<p>The proposed tablet will contain 300 mg of tenofovir and 200 mg of FTC and will be administered in combination with at least one other anti-HIV medicine. The company said that following approval of the fco-formulation, each drug would continue to be sold individually.<\/p>\n<p>The full statement is at:<br \/>\n<a href=\"http:\/\/www.gilead.com\/wt\/sec\/pr_572624\">http:\/\/www.gilead.com\/wt\/sec\/pr_572624<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Gilead Sciences announced on May 17 that the US Food and Drug Administration (FDA) had granted priority review status to the New Drug Application (NDA) for the fixed dose co-formulation of the company\u2019s anti-HIV medications tenofovir (Viread) and FTC (emtricitabine, &hellip;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-9608","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/9608","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=9608"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/9608\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=9608"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=9608"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=9608"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}