Important note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.
Food and Drug Administration - July 1, 2005
Tentative approval means that although existing patents and/or exclusivity prevent marketing the particular product in the U.S. at this time, the product meets all FDA's quality, safety and efficacy standards. The tentative approval allows this product to be considered for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).
Stavudine is a member of the class of drugs called Nucleoside Reverse Transcripts Inhibitors (NRTIs) which helps keep the AIDS virus from reproducing. Stavudine is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Richard Klein, HIV/AIDS Program Director, Office of Special Health Issues
Food and Drug Administration
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SOURCE: Food and Drug Administration (FDA).
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