Several AIDS Drugs Tentatively Approved

The FDA has tentatively approved several generic AIDS drugs under a relief plan intended to target prevention, treatment, and care programs to countries that are among the most afflicted by the disease.

Since June 2005, a half dozen drug applications have received tentative FDA approval, meaning that the products will now be available for consideration for purchase and use outside the United States under the President’s Emergency Plan for AIDS Relief (PEPFAR). The plan, which President Bush first announced in his 2003 State of the Union Address, is providing $15 billion to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest-hit countries. The PEPFAR plan is designed to prevent 7 million new HIV infections, treat at least 2 million HIV-infected people, and care for 10 million people infected and affected by HIV/ AIDS, including orphans and other children who are vulnerable.

The FDA’s tentative approval of these drugs means that although existing patents and exclusivity prevent them from being marketed in the United States, the drugs meet all the FDA’s quality, safety, and effectiveness standards required for marketing in this country. See www.fda.gov/oashi/aids/hiv. html for more information on HIV/ AIDS and the drugs used to treat the disease.

Copyright Superintendent of Documents Sep/Oct 2005