{"id":7849,"date":"2010-02-06T00:05:53","date_gmt":"2010-02-06T00:05:53","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=7849"},"modified":"2013-08-06T08:21:46","modified_gmt":"2013-08-06T08:21:46","slug":"fda-approval-of-generic-arvs-6","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/7849","title":{"rendered":"FDA approval of generic ARVs"},"content":{"rendered":"

Since the last issue of HTB, the\u00a0US Food and Drug Administration (FDA) has granted tentative approval for the following new generic ARV products.<\/strong><\/p>\n\n\n\n\n
Drug and formulation<\/strong><\/td>\nManufacturer, Country<\/strong><\/td>\nApproval date<\/strong><\/td>\n<\/tr>\n
3TC\/AZT\/nevirapine 150\/300\/200mg. Fixed Dose Combination<\/td>\nStrides Arcolab, India<\/td>\n22 December 2009<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u201cTentative Approval\u201d means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but because of existing patents and\/or exclusivity rights, it cannot yet be marketed in the United States. Tentative approval does, however make the product eligible for consideration 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:
\nhttp:\/\/www.accessdata.fda.gov\/scripts\/cder\/ob\/default.cfm<\/a><\/p>\n

COMMENT <\/strong><\/p>\n

This brings the total of FDA approved generic drugs and formulations to 105 since the programme started. An updated list of generic tentative\u00a0approvals is available on the FDA website.
\n<\/strong>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\u00a0US 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\/nevirapine 150\/300\/200mg. Fixed Dose Combination Strides Arcolab, India 22 December …<\/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-7849","post","type-post","status-publish","format-standard","hentry","category-treatment-access"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/7849","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=7849"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/7849\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=7849"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=7849"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=7849"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}