Important note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.
Food and Drug Administration - March 26, 2007
Richard Klein and Kimberly Struble
The tentatively approved product is a generic version of the Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI), Sustiva Tablets, 600 mg, for use in combination with other antiretroviral agents in the treatment of HIV infection. Sustiva, manufactured by Bristol Myers Squibb Co., is currently subject to patent protection.
FDA's tentative approval of this product means that although existing patents and/or exclusivities prevent marketing of this product in the United States, the product has been shown to meet all of FDA's safety, efficacy, and manufacturing quality standards required for marketing in the U.S., and thus qualifies for consideration for purchase under the PEPFAR program for use in qualifying countries.
A complete list of approved and tentatively approved antiretroviral drugs associated with PEPFAR is available at http://www.fda.gov/oia/pepfar.htm.
Richard Klein | Office of Special Health Issues | Food and Drug Administration
Kimberly Struble | Division of Antiviral Drug Products | Food and Drug Administration
070326
FD070305
SOURCE: Food and Drug Administration (FDA).
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