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 8, 2005
Richard Klein
FDA tentative approval means that the product meets all of FDA's quality, safety and efficacy standards, but existing patents and/or exclusivity prevent marketing of the product in the U.S. Tentative approval by FDA, however, makes this Aurobindo generic product available for consideration for purchase and use outside the United States under the President's Emergency Plan for AIDS Relief (PEPFAR).
The Aurobindo lamivudine/zidovudine combination product is a generic version of the U.S. approved Combivir lamivudine/zidovudine combination manufactured by GlaxoSmithKline.
Lamivudine and Zidovudine are nucleoside reverse transcriptase inhibitors (NRTIs), which help keep the AIDS virus from reproducing. This combination antiretroviral drug is intended to be used with other antiretroviral agents in the treatment of HIV-1 infection.
Richard Klein, HIV/AIDS Program Director, Office of Special Health Issues
Food and Drug Administration
050708
FD050702
SOURCE: Food and Drug Administration (FDA).
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