The approval, for lamivudine tablets 150mg, is Ranbaxy’s first tentative approval under the expedited review process of the US President’s emergency plan for AIDS relief (PEPFAR) program.
In combination with other antiretroviral agents, lamivudine, marketed as Epivir by GlaxoSmithKline, is indicated for the treatment of HIV infection.
“We are pleased and proud of our achievement in being granted US FDA tentative approval for lamivudine,” said Dr Brian Tempest, CEO and managing director of Ranbaxy. “This formulation now qualifies as our first product to be included among a portfolio of drugs to be associated with the PEPFAR initiative.”
PEPFAR, the largest international health initiative in history by a government dedicated to a single disease, is America’s unprecedented five-year, $15 billion dollar commitment to bring hope to those suffering from HIV/AIDS globally. Under the program, the US works with partners in host nations, helping build capacity in support of each country’s national strategy.