FDA Grants Tentative Approval for 75th Generic Antiretroviral Drug

Abstract

On October 29, 2008, the US Food and Drug Administration reached a milestone: the 75th anti-retroviral generic drug approved or tentatively approved as part of President Bush's Emergency Plan for AIDS Relief. Marketed by Macleods Pharmaceuticals, Ltd, in India, the 75th drug consists of 150- and 300-mg tablets of generic lamivudine (Figure), a nucleoside analog reverse-transcriptase inhibitor that blocks the enzyme reverse transcriptase, which is important for HIV replication. HIV-infected patients who take lamivudine with other anti-HIV treatments develop fewer 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, MD. “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 the FDA's normal requirements for manufacturing quality and clinical safety and efficacy. The agency says it 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 <6 months. After receiving approval or tentative approval under this expedited process, a generic antiretroviral quickly passes on to the prequalification list maintained by the Secretariat of the World Health Organization (WHO), because of a confidentiality agreement that allows the FDA to share data from its evaluations with the WHO team in Geneva. Generic antiretrovirals given federal approval or tentative approval are also immediately eligible for procurement by recipients of grants from the Global Fund to Fight AIDS, Tuberculosis, and Malaria. In 2003, President Bush launched the Emergency Plan for AIDS Relief to combat global HIV/AIDS. At that time, approximately 50,000 people in sub-Saharan Africa were receiving antiretroviral treatment. Today, the Emergency Plan reaches >1.7 million persons worldwide with antiretroviral treatment, the vast majority of them in sub-Saharan Africa, and supports care for >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. For more information, see www.pepfar.gov or http://www.fda.gov/oia/pepfar.htm