Number of Generic Anti-Retrovirals Available for Use in the President's Emergency Plan for AIDS Relief Reaches 70

June 27, 2008 – Under the expedited-review provisions the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS) has set up to serve the President's Emergency Plan for AIDS Relief, the list of generic anti-retrovirals (ARVs) available for use in HIV/AIDS-treatment programs funded by the U.S. Government has reached 70.  Each of these medicines has received approval or tentative approval from HHS/FDA, which makes them eligible for procurement under the Emergency Plan.  Because of a confidentiality commitment between HHS/FDA and the Secretariat of the World Health Organization (WHO) that allows for the rapid sharing of non-public information, these drugs also quickly appear on the list of the WHO pre-qualification project, upon which many Governments and international organizations base their registration and procurement decisions.  ARVs approved or tentatively approved by HHS/FDA are. also immediately eligible for procurement by recipients of grants from the Global Fund to Fight AIDS, Tuberculosis and Malaria.

"Tentative approval" from HHS/FDA means a generic drug has met all of the normal standards necessary for a medicine to earn approval to be sold in the United States, but that patent or other exclusivities currently prevent the manufacturer of the generic from marketing the product here yet.  As exclusivities expire, the makers of ARVs that have received tentative approval from HHS/FDA may begin to sell these products in the United States.

For more information:

• Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan (U.S. Food and Drug Administration)

Last revised: July 01, 2008