Tentative Approval of Copackaged Antiretroviral for PEPFAR Availability
The Food and Drug Administration (FDA) today is announcing the tentative approval of a copackaged antiretroviral drug regimen, consisting of lamivudine/zidovudine fixed dose combination tablets and nevirapine tablets for the treatment of HIV-1 infection in adults. It is manufactured by Aspen Pharmacare of South Africa.
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.