Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.
Food and Drug Administration - March 8, 2006
Richard Klein, Kimberly Struble
FDA granted tentative approval for the generic formulation of efavirenz on June 24, 2005, and for the combination of lamivudine and zidovudine on July 7, 2005, both manufactured by Aurobindo Pharma LTD. Aurobindo Pharma's lamivudine/zidovudine fixed dose combination tablets are a version of the already FDA approved Combivir tablets manufactured by GlaxoSmithKline, and the efavirenz tablets are a version of Sustiva tablets manufactured by Bristol Myers-Squibb.
A Tentative Approval means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, though it may not yet be marketed in the U.S. due to existing patents and/or exclusivity rights. Tentative approval, however, does make the product eligible for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR) program.
Richard Klein, Office of Special Health Issues
Food and Drug Administration
Kimberly Struble, Division of Antiviral Drug Products
Food and Drug Administration
060308
FD060303
SOURCE: Food and Drug Administration (FDA).
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