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 - June 24, 2005
Richard Klein
Generic efavirenz will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).
The agency's tentative approval means that although existing patents and/or exclusivity prevent marketing of a particular product in the United States, it meets all of FDA's quality, safety and efficacy standards required for marketing in the United States.
Efavirenz is a member of the non-nucleoside reverse transcriptase inhibitors (NNRTIs) class of drugs, which helps keep the AIDS virus from reproducing in cells. This antiretroviral drug 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
050624
FD050604
SOURCE: Food and Drug Administration (FDA).
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