LOS ANGELES, Jan. 25 /PRNewswire/ -- AIDS Healthcare Foundation (AHF) the largest US-based AIDS organization with free AIDS treatment clinics in the US, Africa, Central America and Asia, welcomed the news today that the United States’ Food and Drug Administration (FDA) has approved generic AIDS drugs produced by South Africa’s Aspen Pharmacare. The move makes the pharmaceutical manufacturer the first in the world to receive approval from the US government agency for its generic anti-retroviral drugs to fight AIDS. The FDA’s action also clears the way for Aspen’s far less costly AIDS drugs -- specifically, its combination of lamivudine/zidovudine and nevirapine tablets approved today -- to be utilized in President’s Bush’s ambitious $15 billion, 5-year President’s 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.
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“Today’s FDA’s approval of Aspen’s 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 Aspen’s 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 PEPFAR’s 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.”
Today’s approval is for Aspen’s generic equivalent of the most widely used triple cocktail combination of lamivudine/zidovudine (branded as GSK’s Combivir) and nevirapine (branded as Boehringer Ingelheim’s 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 US President’s Emergency Plan for Aids Relief fund.
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CONTACT: Ged Kenslea, AHF Communication Director, +1-323-860-5225, ormobile, +1-323-791-5526