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Generic Efavirenz Approved by FDA
  The Food and Drug Administration (FDA) today (June 24, 2005) granted tentative approval for efavirenz tablets manufactured by Aurobindo Pharma LTD. of Hyderabad, India. This product is the first tentatively approved generic version of Sustiva tablets (manufactured by Bristol-Myers Squibb).
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
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