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 - January 25, 2005
A Tentative Approval means that FDA has concluded that a drug product has met all of the required quality, safety and efficacy standards, even though it may not yet be marketed in the U.S. due to existing patents and/or exclusivity. It does, however, make the product eligible for use under the President's Emergency Plan for AIDS Relief (PEPFAR) program.
The co-packaged drug products are a complete antiretroviral drug regimen that have met the FDA's quality, safety and efficacy standards, and will be available for potential procurement by PEPFAR for use in South Africa and developing nations. It is the first tentative approval of a product to treat HIV/AIDS under the new expedited FDA review process for PEPFAR, and the first tentative approval of an HIV drug regimen manufactured by a non- U.S.-based generic pharmaceutical company.
Aspen's lamivudine/zidovudine fixed dose combination tablets are a version of the already FDA approved Combivir tablets manufactured by GlaxoSmithKline and the nevirapine tablets are a version of Viramune tablets manufactured by Boehringer-Ingelheim. The new co-packaged product consists of both lamivudine/zidovudine fixed dose tablets and nevirapine tablets, one of each tablet to be taken twice daily, after the initial two week initiation phase of this nevirapine regimen.
Richard Klein, Office of Special Health Issues
Food and Drug Administration
Jeffrey Murray, Division of Antiviral Drug Products
Food and Drug Administration
050125
FD050102
SOURCE: Food and Drug Administration (FDA).
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Always watch for outdated information. This article first appeared in 2005. This material is designed to support, not replace, the relationship that exists between you and your doctor.
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