{"id":24860,"date":"2014-03-24T11:48:00","date_gmt":"2014-03-24T11:48:00","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=24860"},"modified":"2014-03-24T11:48:00","modified_gmt":"2014-03-24T11:48:00","slug":"fda-approvals-of-generic-arvs","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/24860","title":{"rendered":"FDA approvals of generic ARVS"},"content":{"rendered":"

The\u00a0US\u00a0Food\u00a0and\u00a0Drug\u00a0Administration\u00a0(FDA)\u00a0has\u00a0granted\u00a0tentative\u00a0(or\u00a0full**)\u00a0approval\u00a0for\u00a0the\u00a0following\u00a0new\u00a0generic\u00a0ARV\u00a0products\u00a0so\u00a0far\u00a0in\u00a02014.<\/strong><\/p>\n\n\n\n\n\n\n\n\n
Drug\u00a0and\u00a0formulation<\/td>\nManufacturer,\u00a0Country<\/td>\nApproval\u00a0date<\/td>\n<\/tr>\n
atazanavir\u00a0(100\u00a0mg,\u00a0150\u00a0mg,\n

200\u00a0mg\u00a0and\u00a0300\u00a0mg)\u00a0capsules<\/p><\/td>\n

Aurobindo,\u00a0India<\/td>\n31\u00a0Jan\u00a02014<\/td>\n<\/tr>\n
3TC\/AZT\u00a0(150\u00a0mg\/300\u00a0mg\u00a0tablet)\u00a0**<\/td>\nHetero\u00a0Labs,\u00a0India<\/td>\n3\u00a0Feb\u00a02014<\/td>\n<\/tr>\n
tenofovir\/FTC\u00a0(300\u00a0mg\/200\u00a0mg)\u00a0tablets<\/td>\nCipla,\u00a0India<\/td>\n26\u00a0Feb\u00a02014<\/td>\n<\/tr>\n
tenofovir\/3TC\u00a0(300\u00a0mg\/\u00a0300\u00a0mg)\n

+\u00a0copackaged\u00a0nevirapine\u00a0(200mg)<\/p><\/td>\n

Hetero\u00a0labs,\u00a0India<\/td>\n14\u00a0Mar\u00a02014<\/td>\n<\/tr>\n
atazanavir\/ritonavir\u00a0(300\u00a0mg\/100\u00a0mg)\u00a0tablets<\/td>\nEmcure,\u00a0India<\/td>\n17\u00a0Mar\u00a02014<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

** full approval, otherwise all tentative approval; FDC: Fixed Dose Combination<\/p>\n

Tentative approval 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. Full approval means the patent has expired for the original compounds and the product can be used in the US.<\/p>\n

An updated list of generic tentative approvals (now at 170) is available on the FDA website:
\nhttp:\/\/www.fda.gov\/oia\/pepfar.htm<\/a><\/p>\n

A list of generic ARVs now available for use inside the US is also online:<\/p>\n

http:\/\/www.fda.gov\/ForConsumers\/ByAudience\/ForPatientAdvocates\/HIVandAIDSActivities\/ucm118944.htm<\/a><\/p>\n

Source: FDA list serve (various dates, as approved).<\/p>\n","protected":false},"excerpt":{"rendered":"

The\u00a0US\u00a0Food\u00a0and\u00a0Drug\u00a0Administration\u00a0(FDA)\u00a0has\u00a0granted\u00a0tentative\u00a0(or\u00a0full**)\u00a0approval\u00a0for\u00a0the\u00a0following\u00a0new\u00a0generic\u00a0ARV\u00a0products\u00a0so\u00a0far\u00a0in\u00a02014. Drug\u00a0and\u00a0formulation Manufacturer,\u00a0Country Approval\u00a0date atazanavir\u00a0(100\u00a0mg,\u00a0150\u00a0mg, 200\u00a0mg\u00a0and\u00a0300\u00a0mg)\u00a0capsules Aurobindo,\u00a0India 31\u00a0Jan\u00a02014 3TC\/AZT\u00a0(150\u00a0mg\/300\u00a0mg\u00a0tablet)\u00a0** Hetero\u00a0Labs,\u00a0India 3\u00a0Feb\u00a02014 tenofovir\/FTC\u00a0(300\u00a0mg\/200\u00a0mg)\u00a0tablets Cipla,\u00a0India 26\u00a0Feb\u00a02014 tenofovir\/3TC\u00a0(300\u00a0mg\/\u00a0300\u00a0mg) +\u00a0copackaged\u00a0nevirapine\u00a0(200mg) Hetero\u00a0labs,\u00a0India 14\u00a0Mar\u00a02014 atazanavir\/ritonavir\u00a0(300\u00a0mg\/100\u00a0mg)\u00a0tablets Emcure,\u00a0India 17\u00a0Mar\u00a02014 ** full approval, otherwise all tentative approval; FDC: Fixed Dose Combination Tentative approval means that FDA has concluded that …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[38],"tags":[],"class_list":["post-24860","post","type-post","status-publish","format-standard","hentry","category-treatment-access"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/24860","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=24860"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/24860\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=24860"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=24860"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=24860"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}