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New Formulation of Generic d4T Receives Tentative Approval by FDA
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The Food and Drug Administration (FDA) today (July 1, 2005) announced the tentative approval of stavudine capsules manufactured by Aurobindo Pharma LTD., Hyderabad, India. This formulation of stavudine is the first generic version of the approved drug, Zerit, manufactured by Bristol-Myers Squibb, to receive tentative approval.
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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