{"id":10202,"date":"2010-04-02T11:42:25","date_gmt":"2010-04-02T11:42:25","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=10202"},"modified":"2013-08-08T12:29:19","modified_gmt":"2013-08-08T12:29:19","slug":"fda-approval-of-generic-arvs-7","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/10202","title":{"rendered":"FDA approval of generic ARVs"},"content":{"rendered":"

Since the last issue of HTB, the US\u00a0Food and Drug Administration (FDA) has granted tentative approval for the following new generic ARV products.<\/strong><\/p>\n\n\n\n\n\n\n
Drug and formulation<\/strong><\/td>\nManufacturer, Country<\/strong><\/td>\nApproval date<\/strong><\/td>\n<\/tr>\n
Tenofovir DF, 300mg tabs<\/td>\nHetero, India<\/td>\n06 April 2010<\/td>\n<\/tr>\n
Nevirapine tablets for oral suspension, 50 mg, for children weighing >5 kg<\/td>\nAurobindo, India<\/td>\n24 February 2010<\/td>\n<\/tr>\n
Efavirenz cross-scored tablets, 200 mg (to be broken into two 100 mg or four 50 mg doses for paediatric dosing.<\/td>\nStrides Arcolab, India<\/td>\n12 February 2010<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u0093Tentative Approval\u0094 means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but because of\u00a0existing patents and\/or exclusivity rights, it cannot yet be marketed in the United States. Tentative approval does, however make the product eligible for\u00a0consideration for purchase under the PEPFAR program for use outside the United States.<\/p>\n

Effective patent dates are listed in the agency\u0092s publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the\u00a0Orange Book:<\/p>\n

http:\/\/www.accessdata.fda.gov\/scripts\/cder\/ob\/default.cfm<\/a><\/p>\n

comment<\/strong><\/h2>\n

This brings the total of FDA approved generic drugs and formulations to 108 since the programme
\nstarted.<\/strong><\/p>\n

An updated list of generic tentative approvals is available on the FDA website:<\/p>\n

http:\/\/www.fda.gov\/oia\/pepfar.htm<\/a><\/p>\n

Source: FDA list serve:<\/p>\n

<a
\nhref=”http:\/\/www.fda.gov\/ForConsumers\/ByAudience\/ForPatientAdvocates\/HIVandAIDSActivities\/ucm122951.htm”>http:\/\/www.fda.gov\/ForConsumers\/ByAudience\/ForPat
\nientAdvocates\/HIVandAIDSActivities\/ucm122951.htm<\/p>\n","protected":false},"excerpt":{"rendered":"

Since the last issue of HTB, the US\u00a0Food and Drug Administration (FDA) has granted tentative approval for the following new generic ARV products. Drug and formulation Manufacturer, Country Approval date Tenofovir DF, 300mg tabs Hetero, India 06 April 2010 Nevirapine …<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[38],"tags":[],"class_list":["post-10202","post","type-post","status-publish","format-standard","hentry","category-treatment-access"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/10202","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=10202"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/10202\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=10202"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=10202"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=10202"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}