{"id":21354,"date":"2013-05-29T14:59:35","date_gmt":"2013-05-29T14:59:35","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=21354"},"modified":"2013-05-29T16:35:58","modified_gmt":"2013-05-29T16:35:58","slug":"fda-approval-of-generic-arvs-20","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/21354","title":{"rendered":"FDA approval of generic ARVs"},"content":{"rendered":"<p><strong>Since the last issue of HTB, the US Food and Drug Administration (FDA) has granted tentative approval for the following new generic ARV products.<\/strong><\/p>\n<table border=\"0\">\n<tbody>\n<tr>\n<th scope=\"col\">Drug and formulation<\/th>\n<th scope=\"col\">Manufacturer, Country<\/th>\n<th scope=\"col\">Approval date<\/th>\n<\/tr>\n<tr>\n<td>efavirenz\/FTC\/tenofovir FDC tablets, 600 mg\/200 mg\/300 mg<\/td>\n<td>Aurobindo, India<\/td>\n<td>2 April 2013<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>FDC: Fixed Dose Combination<\/p>\n<p>Effective patent dates are listed in the agency&#8217;s publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book:<br \/>\n<a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cder\/ob\/default.cfm\">http:\/\/www.accessdata.fda.gov\/scripts\/cder\/ob\/default.cfm<\/a><\/p>\n<p>An updated list of generic tentative approvals (now at 140) is available on the FDA website:<br \/>\n<a href=\"http:\/\/www.fda.gov\/oia\/pepfar.htm\">http:\/\/www.fda.gov\/oia\/pepfar.htm<\/a><\/p>\n<p>Source:<\/p>\n<p>FDA list serve<br \/>\n<a href=\"http:\/\/www.fda.gov\/InternationalPrograms\/FDABeyondOurBordersForeignOffices\/AsiaandAfrica\/ucm119231.htm\">http:\/\/www.fda.gov\/InternationalPrograms\/FDABeyondOurBordersForeignOffices\/AsiaandAfrica\/ucm119231.htm<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Since the last issue of HTB, the US Food and Drug Administration (FDA) has granted tentative approval for the following new generic ARV products. Drug and formulation Manufacturer, Country Approval date efavirenz\/FTC\/tenofovir FDC tablets, 600 mg\/200 mg\/300 mg Aurobindo, India &hellip;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[38],"tags":[],"class_list":["post-21354","post","type-post","status-publish","format-standard","hentry","category-treatment-access"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/21354","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=21354"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/21354\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=21354"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=21354"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=21354"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}