Ranbaxy Laboratories (RLL) has received a tentative approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Lamivudine tablets, 150 mg. According to a release issued by Ranbaxy to the BSE, the tentative approval from the USFDA is the company's and India's first under its expedited review process to support PEPFAR. In combination with other anti retroviral agents (ARVs), Lamivudine tablets are indicated for the treatment of HIV infection.Dr. Brian W. Tempest, CEO and MD, of Ranbaxy, said, "We are pleased with the tentative approval for Lamivudine granted by the USFDA. This is a major step in making our life saving ARV medicines available to more and more HIV/AIDS patients in the developing world. We will continue with our efforts to obtain speedy approval for all our ARVs with the USFDA in support of PEPFAR. In tandem we are also pursuing WHO prequalification for the same products", the release said.
