Important note: Information in this article was accurate in 2009. The state of the art may have changed since the publication date.
Food and Drug Administration - September 4, 2009
"Tentative approval" means that FDA has concluded that a drug product meets all required quality, safety and efficacy standards, but is not presently eligible for final approval or marketing in the U.S. because of existing patents and/or exclusivity rights. However, tentative approval does make the product eligible for purchase outside the United States under the President's Emergency Plan for AIDS Relief (PEPFAR) <http://www.pepfar.gov/>.
As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility, and of the facilities performing the bioequivalence studies, to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application prior to granting approval or tentative approval to these applications.
A complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan can be found on the FDA web site: <http://www.fda.gov/InternationalPrograms/FDABeyondOurBordersFore ignOffices/AsiaandAfrica/ucm119231.htm>
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
090904
FD090901
SOURCE: Food and Drug Administration (FDA).
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