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 - August 4, 2009
Richard Klein & Kimberly Struble
"Tentative approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patent protections. Tentative approval does, however, make the product eligible for consideration for purchase outside the United States under the PEPFAR program.
This product is a generic version of Sustiva capsules, 200 mg, a Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI), manufactured by Bristol Myers-Squibb. Effective patent dates can be found in the FDA publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book" <http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm? Appl_No=020972&TABLE1=OB_Rx>
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 list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA website <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
090804
FD090804
SOURCE: Food and Drug Administration (FDA).
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