AHF Welcomes FDA's First-Ever Approval of Generic AIDS Drugs

LOS ANGELES -- AIDS Healthcare Foundation (AHF) the largest U.S.-based AIDS organization with free AIDS treatment clinics in the United States, Africa, Central America and Asia, welcomed the news that the United States Food and Drug Administration (FDA) has approved generic AIDS drugs produced by South Africas Aspen Pharmacare.  The move makes the pharmaceutical manufacturer the first in the world to receive approval from the U.S. government agency for its generic anti-retroviral drugs to fight AIDS.  The FDAs action also clears the way for Aspens far less costly AIDS drugs -- specifically, its combination of lamivudine/zidovudine and nevirapine tablets -- to be utilized in Presidents Bushs ambitious $15 billion, 5-year Presidents Emergency Plan For AIDS Relief (PEPFAR).  The President had made FDA approval a requirement of any generic medicines that PEPFAR uses in its global treatment efforts.

Todays FDAs approval of Aspens generic life-saving AIDS drugs could truly save hundreds of thousands of lives, said Michael Weinstein, president of AIDS Healthcare Foundation. This approval now allows PEPFAR to utilize Aspens generic AIDS drugs in its global treatment efforts to get two million people in treatment. We strongly urge the President and PEPFAR officials to quickly incorporate these effective, yet far less costly anti-retroviral drugs into PEPFARs treatment programs in Africa and the Caribbean. We believe that three times as many people can be treated -- and three times as many lives saved -- by using safe, effective and far cheaper generic AIDS drugs.


The approval is for Aspens generic equivalent of the most widely used triple cocktail combination of lamivudine/zidovudine (branded as GSKs Combivir) and nevirapine (branded as Boehringer Ingelheims Viramune) tablets in conventional adult dosages.

The FDA approval now means that Aspen has become the first accredited generic supplier to have access to the Presidents Emergency Plan for Aids Relief fund.

Source: AIDS Healthcare Foundation