Production of Generic Antiretroviral Drug Combination Could Begin in March, South Africa's Aspen Pharmacare Says
January 27, 2005
The production of a generic antiretroviral drug combination that was recently approved by FDA could begin as early as March or April, expanding treatment for people living with HIV/AIDS in the 12 African countries covered under the President's Emergency Plan for AIDS Relief, the AP/Long Island Newsday reports (Leonard, AP/Long Island Newsday, 1/26). FDA on Tuesday announced that it has approved a generic version of a widely used co-packaged antiretroviral drug regimen made by South Africa's Aspen Pharmacare. The regimen includes a generic version of GlaxoSmithKline's fixed-dose combination Combivir, which contains the antiretroviral drugs lamivudine and zidovudine, and a version of Boehringer Ingelheim's Viramune, known generically as nevirapine, which Aspen packages together. The FDA approval is expected to expand AIDS treatment in the developing world by allowing PEPFAR to purchase the drugs. PEPFAR is a five-year, $15 billion program that directs funding for HIV/AIDS, tuberculosis and malaria to 15 focus countries, including Botswana, Ethiopia, Cote d'Ivoire, Kenya, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Zambia, Haiti, Guyana and Vietnam (Kaiser Daily HIV/AIDS Report, 1/26).
Registration, Production Details
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