{"id":15546,"date":"2011-08-01T11:04:49","date_gmt":"2011-08-01T11:04:49","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=15546"},"modified":"2011-08-01T11:04:49","modified_gmt":"2011-08-01T11:04:49","slug":"fda-approval-of-generic-arvs-14","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/15546","title":{"rendered":"FDA approval of generic ARVs"},"content":{"rendered":"<p>Since the last issue of HTB, the US Food and Drug Administration (FDA) has granted tentative approval (or ** full approval) for the following new generic ARV products.<\/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>AZT\/3TC tablets, 300 mg\/150 mg<\/td>\n<td>Teva, USA **<\/td>\n<td>25 May 2011<\/td>\n<\/tr>\n<tr>\n<td>Tenofovir DF tablets, 300 mg<\/td>\n<td>Strides, India<\/td>\n<td>25 May 2011<\/td>\n<\/tr>\n<tr>\n<td>Abacavir\/3TC scored tablets, 60 mg\/30 mg<\/td>\n<td>Cipla, India<\/td>\n<td>12 May 2011<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>** Full approval enables this generic to be sold in the US.<\/p>\n<p>FDC: Fixed Dose Combination<\/p>\n<p>Effective patent dates are listed in the agency\u0092s 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 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 (or ** full approval) for the following new generic ARV products. Drug and formulation Manufacturer, Country Approval date AZT\/3TC tablets, 300 mg\/150 mg &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-15546","post","type-post","status-publish","format-standard","hentry","category-treatment-access"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/15546","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=15546"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/15546\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=15546"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=15546"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=15546"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}