AUROBINDO RECEIVES TENTATIVE FDA APPROVAL UNDER PEPFAR
The FDA has granted tentative approval to an Indian firm's lamivudine tablets, a generic version of GlaxoSmithKline's HIV-1 treatment, Epivir.
Manufactured by Aurobindo Pharma of Hyderabad, India, the lamivudine generic will be made available for purchase under President Bush's Emergency Plan for AIDS Relief (PEPFAR), the FDA said. A member of the nucleoside reverse transcriptase inhibitors drug class, lamivudine is used in combination with other antiretroviral agents to treat HIV-1 infection by blocking the HIV from infecting uninfected cells in the body.
Launched in 2003, PEPFAR is a five-year, $15 billion plan, including nearly $10 billion in new money, to support global efforts combating AIDS in Africa and the Caribbean. The plan aims to provide AIDS drugs to 2 million HIV-infected patients.
This is the second application for generic Epivir that has received tentative approval, FDA said. In January, the FDA granted tentative approval for Aspen Pharmacare of South Africa's HIV-1 treatment regimen consisting of co-packaged lamivudine/zidovudine fixed-dose combination tablets and nevirapine tablets.