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FDA NEWS RELEASE

This release was revised on August 15, 2007.

FOR IMMEDIATE RELEASE
August 13, 2007

Media Inquiries:
Christopher Kelly, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Grants Tentative Approval for 50th and 51st Anti-Retroviral Drugs Under President's Emergency Plan for AIDS Relief

The U.S. Food and Drug Administration, part of the U.S. Department of Health and Human Services, today granted tentative approval for nevirapine tablets, indicated for use with other anti-retroviral agents for the treatment of HIV-1 infection, and for the pediatric triple-fixed-dose combination tablet of lamivudine, stavudine and nevirapine — the first fixed-dose anti-HIV product designed to treat children under the age of 12 years. These two drugs mark the 50th and 51st AIDS drugs approved or tentatively approved for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).

The fixed-dose combination of lamivudine, stavudine, and nevirapine comprises a complete HIV regimen taken twice daily, and patients can use it once they have tolerated 14 days of lead-in treatment with nevirapine, taken once daily. The tablet combination can also be dissolved in water for children who cannot swallow tablets. That all three drugs are combined in one tablet, and that this tablet can be stored, distributed, and administered easily to children, are significant advances in the treatment of children infected with HIV in countries in which the PEPFAR is working.

"The tentative approvals of these two essential anti-HIV drugs, the 50th and 51st actions by the FDA under the President's Emergency Plan for AIDS Relief, bolster the commitment made by President Bush to ensure the rapid delivery of unprecedented amounts of safe, effective, and quality drugs, at a lower cost, to help those most in need," said HHS Secretary Mike Leavitt in marking the milestone. "I am excited to visit Africa next week, and to visit sites where the drugs reviewed under the FDA expedited process for the Emergency Plan are giving patients new hope."

Today's tentative approvals under the PEPFAR are part of the President's five-year, $15 billion effort to fight the HIV/AIDS pandemic around the world — the largest commitment ever by a single nation toward an international health initiative. As of March 31, 2007, the PEPFAR supported life-saving anti-retroviral treatment for over 1.1 million men, women and children in 15 focus countries in sub-Saharan Africa, Asia and the Caribbean.

Both nevirapine tablets and the triple-fixed-dose combination of lamivudine, stavudine and nevirapine, as well as 46 other anti-HIV drugs, are "tentatively approved" generic drugs (or drug combinations) evaluated by HHS/FDA as part of the PEPFAR, but which are not available for sale in the United States because of existing patent protection or other U.S. marketing protections.

HHS/FDA's tentative approval means that, although existing patents and/or marketing exclusivity prevent the approval of the product in the United States, the product meets all of HHS/FDA's manufacturing quality and clinical safety and efficacy requirements — which thus helps to ensure AIDS patients abroad who receive these medications get the same quality of medications as Americans. Three other drugs evaluated by HHS/FDA as part of the PEPFAR have been approved for marketing in the United States, because there are no current patent or other U.S. marketing protections that would preclude their marketing in this country. All 51 of the drugs can all be purchased outside the United States by host-country governments and other partners with U.S. taxpayer dollars.

HHS and its component agencies, including FDA, is part of a multi-agency effort led by the Office of the U.S. Global AIDS Coordinator to accomplish the President's goals of treating two million HIV-infected people, preventing seven million new infections, and caring for 10 million people infected with and affected by HIV/AIDS, including orphans and vulnerable children. On May 30, President Bush announced his intention to work with Congress to reauthorize the PEPFAR for five additional years.

"Support for anti-retroviral treatment is more than just drugs – it is a sign of hope," said Ambassador Mark R. Dybul, the U.S. Global AIDS Coordinator. "It reflects the idea that President Bush has stated so well — that where you live should not determine if you live or die from HIV/AIDS."

In 2004, HHS/FDA implemented an expedited application-review process under the PEPFAR for individual anti-retroviral (ARV) drug formulations, co-packaged versions of individual ARV drug formulations, and fixed-dose ARV combinations. The process under PEPFAR includes an HHS/FDA commitment to work closely with manufacturers before they submit a marketing application to the HHS/FDA, especially those who have never previously submitted marketing applications, and to conduct a priority assessment of those applications.

"The FDA has helped save lives by making these much-needed, high-quality, generic drugs for AIDS available for patients in countries served by the Emergency Plan," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "In addition, our goal is to assure that drugs purchased by the Emergency Plan meet the same safety, efficacy, and manufacturing standards as drugs used in the United States."

The U.S. Government remains committed to funding the purchase of the lowest-cost anti-retrovirals under the PEPFAR, whether they are innovator or generic drugs, as long as the medications have been demonstrated to be safe, effective, and of high quality. Emergency Plan purchases of drugs also must be consistent with international law.

As part of the PEPFAR, HHS/FDA is collaborating with the World Health Organization's (WHO) Prequalification Programme. As a result of this collaboration, HHS/FDA approved or tentatively approved anti-retroviral drugs are placed on the list maintained by the WHO Prequalification Programme. This is a program many countries with developing economies use to guide their purchasing of drug products from specific manufacturers so they can be assured they are purchasing quality medicinal products.

"The countries of the world that depend on the WHO Prequalification Programme to help them purchase quality products have benefited immensely by this cooperation between HHS/FDA and the WHO," said Dr. Howard Zucker, WHO Assistant Director-General for Health and Pharmaceuticals. "Assuring the quality of products like this one made especially for children in developing economies is a major cornerstone of our battle against the HIV epidemic and of our effort to help assure children have access to quality medicines."

In addition, HHS and FDA continue to work to strengthen the knowledge and training of in-country, national drug regulatory authorities in the PEPFAR focus countries, alone and in collaboration with each other, so that they can better help assure the quality of the medical products available to their citizens.

For more information on the President's Emergency Plan for AIDS Relief, visit www.pepfar.gov

To see a consumer article called "Improving Access to HIV/AIDS Drugs Abroad," visit http://www.fda.gov/consumer/updates/pepfar081307.html

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