Today, U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg announced the agency has approved or tentatively approved a total of 152 antiretroviral drugs in association with the President's Emergency Plan for AIDS Relief (PEPFAR) to treat those infected with HIV/AIDS
in countries that lack the tools needed to fight the AIDS epidemic.
The most recent FDA actions in association with PEPFAR were tentative approvals of the following generic drugs:
- abacavir oral solution (Hetero Labs Ltd. Unit III, July 2, 2012)
- lopinavir and ritonavir oral solution (Cipla Ltd., June 29, 2012)
- efavirenz tablets (Edict Pharmaceuticals Private Ltd., June 25, 2012 and Micro Labs Ltd., June 20, 2012)
Tentative approval means that although FDA has found that a drug product has met all required manufacturing quality, clinical safety, and efficacy requirements, it cannot be approved for marketing in the U.S. at this time because of existing patents and/or marketing exclusivity. However, the product is eligible for purchase outside the U.S. through the PEPFAR program. All FDA reviews of drug applications received in association with PEPFAR are expedited, as are any inspections of the overseas manufacturing facilities.
Established in 2003, the PEPFAR program seeks to prevent, treat, and care for those infected with and affected by HIV/AIDS worldwide. It is a cooperative effort that involves the FDA and other Department of Health and Human Services agencies, the State Department's Office of the U.S. Global AIDS Coordinator, U.S. Department of Defense, other federal agencies, host country governments, and many international partners. PEPFAR represents the largest commitment by any nation to combat a single disease.
"PEPFAR is driven by a shared, global responsibility to save lives affected by HIV and AIDS," said Commissioner Hamburg, M.D. "Thanks to the hard work and commitment of hundreds of FDA staff and our partners, we now have safe and effective antiretroviral drugs that are widely available at low cost and in forms that allow for better adherence. Together, we are changing the course of the AIDS epidemic."