FDA Grants Tentative Approval for Matrix’s Antiretroviral Drug Abacavir
India-based Matrix Laboratories recently received tentative approval from FDA to produce 300 milligram tablets of the antiretroviral drug abacavir sulfate, Reuters/Yahoo! Asia News reports (Reuters/Yahoo! Asia News, 4/10). The drug is used in combination with other antiretroviral drugs to treat HIV-1 infection. Abacavir is the generic version of GlaxoSmithKline's Ziagen (Kaiser Daily HIV/AIDS Report, 5/25/06). The tentative approval designation means the drug meets FDA safety and efficacy standards but cannot be sold in the U.S. because of existing patents or exclusivity agreements, although it can be used by relief organizations outside the U.S. under the President's Emergency Plan for AIDS Relief (Kaiser Daily HIV/AIDS Report, 6/29/06).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.