Important note: Information in this article was accurate in October 2006. The state of the art may have changed since the publication date.
FDA tentative approvals of generic ARVs
HIV Treat Bull - 2006 October;7(10):
Since the last issue of HTB, the US Food and Drug Administration (FDA) has granted tentative approval for the following new generic ARV products:
“Tentative Approval” means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, though it may not be marketed in the U.S. because of existing patents and/or exclusivity rights. Tentative approval, however, does make the product eligible for consideration for purchase under the PEPFAR program.
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This brings the total of FDA approved generic drugs and formulations to over 26 since the programme was launched.
An updated list of generic tentative approvals is included as a table on the i-Base website: http://www.i-base.info/itpc/fdageneric.html
Whilst generic approval and competition have produced a side range of NNRTI-based options for first-line therapy, protease inhibitors and second-line RTIs, or other drugs effective for treatment experienced patients, are clearly missing from this list.
An archive of past list serve announcements is available on the FDA web site
2006-10-10
IB060710-13
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