Generic AIDS Drugs Cleared for Use in Africa
FDA Grants Tentative Approval to Generic Antiretroviral Drug Cocktail
Jan. 27, 2005 -- A generic version of the antiretroviral drug cocktail used in HIV and AIDS treatment may soon arrive in Africa to help treat people in areas hardest hit by the disease, but at a fraction of the current cost.
The FDA announced this week that it has granted tentative approval for a generic antiretroviral drug regimen manufactured by Aspen Pharmacare of South Africa to treat HIV infection.
The tentative approval means that although existing patents prohibit the sale of the generic HIV/AIDS drugs in the U.S., the generic drugs meet the FDA's safety, efficacy, and quality standards. This makes the drugs available for purchase by relief organizations funded by President Bush's Emergency Plan for AIDS Relief.
"The goal of the emergency plan is to make safe, effective, and affordable quality drugs available quickly for patients with HIV/AIDS," says Lester M. Crawford, acting FDA Commissioner, in a news release.
The tentatively approved HIV/AIDS drug cocktail consists of co-packaged lamivudine/zidovudine combination tablets and nevirapine tablets. The combination tablets are a version of the already approved Combivir drug produced by GlaxoSmithKline, and the nevirapine tablets are a generic version of Viramine tablets made by Boehringer-Ingelheim. GlaxoSmithKline is a WebMD sponsor.