Ranbaxy Laboratories Limited has received a tentative approval from the US FDA to manufacture and market Lamivudine Tablets, 150 mg.
According to a release, this is India's first tentative approval from the US FDA under its expedited review process to support President's Emergency Plan for AIDS Relief (PEPFAR). In combination with other anti retroviral agents (ARVs), Lamivudine Tablets are indicated for the treatment of HIV infection.
Commenting on this development, Dr. Brian W. Tempest, CEO and managing director, said, "We are pleased with the tentative approval for Lamivudine granted by the US FDA. This is a major step in making our life saving ARV medicines available to more and more HIV/AIDS patients in the developing world."