FDA grants tentative approval for 75th generic anti-retroviral drug

Oct 29 2008

The Food and Drug Administration within the U.S. Department of Health and Human Services (HHS) has reached the milestone of the 75th anti-retroviral generic drug approved or tentatively approved as part of President Bush's Emergency Plan for AIDS Relief (PEPFAR).

Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections.

"HHS/FDA has helped save lives by making high quality, anti-retroviral generic drugs available quickly, at a lower cost, for those most in need under the President's Emergency Plan," said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. "As we grant tentative approval for the 75th product, our efforts won't stop: we will continue to provide review of applications for safe and effective treatments for AIDS to combat this global concern."

"Tentative approval" means that although existing patents and/or marketing exclusivity prevent the approval of the product in the United States at this time, the product meets all of HHS/FDA's normal requirements for manufacturing quality and clinical safety and efficacy.

HHS/FDA performs all of its reviews of applications received in association with the Emergency Plan on an expedited basis; the agency reviewed this application for lamivudine tablets in less than six months. After receiving approval or tentative approval from HHS/FDA under this expedited process, a generic anti-retroviral passes quickly on to the pre-qualification list maintained by the Secretariat of the World Health Organization (WHO), because of a confidentiality agreement that allows HHS/FDA to share data from its evaluations with the WHO team in Geneva. Generic anti-retrovirals given approval or tentative approval by HHS/FDA are also immediately eligible for procurement by recipients of grants from the Global Fund to Fight AIDS, Tuberculosis and Malaria.

In 2003, President George W. Bush launched his Emergency Plan for AIDS Relief to combat global HIV/AIDS - the largest commitment by any nation to combat a single disease in history. At that time, about 50,000 people in sub-Saharan Africa were receiving anti-retroviral treatment. Today, the Emergency Plan reaches more than 1.7 million worldwide with anti-retroviral treatment, the vast majority of them in sub-Saharan Africa, and supports care for more than 6.6 million people, including 2.7 million orphans and vulnerable children. To date, interventions funded by the Emergency Plan have allowed mothers to give birth to nearly 200,000 HIV-free children.

In 2004, HHS/FDA implemented an expedited process under the Emergency Plan to review individual, generic anti-retroviral (ARV) drug formulations, co-packaged versions of individual ARV drug formulations, and fixed-dose ARV combinations. The expedited process includes a commitment by HHS/FDA and the Office of the U.S. Global AIDS Coordinator to work closely with manufacturers before they submit a marketing application to HHS/FDA, especially those firms that have never previously submitted to the agency, and to conduct a priority assessment of those applications.

On July 30, 2008, President Bush signed into law the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis and Malaria Reauthorization Act of 2008, which reauthorized and expanded the Emergency Plan for five additional years, from 2009 through 2013. The legislation authorizes up to $38 billion over five years for bilateral HIV/AIDS programs under the Emergency Plan, activities under the President's Malaria Initiative, and bilateral U.S. Government international work against tuberculosis, as well as contributions to the Global Fund.