{"id":15813,"date":"2011-10-01T12:15:59","date_gmt":"2011-10-01T12:15:59","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=15813"},"modified":"2011-10-01T12:15:59","modified_gmt":"2011-10-01T12:15:59","slug":"fda-approval-of-generic-arvs-15","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/15813","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 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>3TC\/AZT 30 mg\/60 mg for pediatric patients 3 months and older weighing at least 5 kg.<\/td>\n<td>Cipla, India<\/td>\n<td>22 September 2011<\/td>\n<\/tr>\n<tr>\n<td>3TC\/tenofovir 300 mg\/300 mg FDC tablets co-package with nevirapine 200mg tablets<\/td>\n<td>Matric laboratories, India<\/td>\n<td>8 September 2011<\/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:<span><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><\/span><\/p>\n<p>An updated list of generic tentative approvals is available on the FDA website:<span><br \/>\n<a href=\"http:\/\/www.fda.gov\/oia\/pepfar.htm\">http:\/\/www.fda.gov\/oia\/pepfar.htm<\/a><\/span><\/p>\n<p>Source: FDA list serve:<span><br \/>\n<a href=\"http:\/\/www.fda.gov\/InternationalPrograms\/FDABeyondOurBordersForeignOffices\/AsiaandAfrica\/ucm119231.htm\">http:\/\/www.fda.gov\/InternationalPrograms\/FDABeyondOurBordersForeignOffices\/AsiaandAfrica\/ucm119231.htm<\/a><\/span><\/p>\n<p>Global Fund adopts restructuring recommendations and close to 50% funding shortfall for next round of grants<\/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 3TC\/AZT 30 mg\/60 mg for pediatric patients 3 months &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-15813","post","type-post","status-publish","format-standard","hentry","category-treatment-access"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/15813","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=15813"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/15813\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=15813"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=15813"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=15813"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}