Ranbaxy gets US FDA approval for lamivudine
EPP News Bureau – New Delhi
Ranbaxy Laboratories (RL) announced that it has received a tentative approval from the US Food and Drug Administration (FDA) to manufacture and market lamivudine tablets.
This is Ranbaxy’s and India’s first tentative approval from the US FDA under its expedited review process to support the US President’s Emergency Plan for AIDS Relief initiative (pepfar). In combination with other anti-retroviral agents (ARVs), lamivudine tablets are indicated for the treatment of HIV infection, according to a press release.
All Ranbaxy ARVs including lamivudine tablets 150 mg are manufactured at the company’s state-of-the-art manufacturing facilities inspected and approved by some of the most stringent agencies in the world, including the US FDA, the release added.
Commenting on this development, Dr Brian W Tempest, CEO and managing director, RL, said, ‘‘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 US FDA in support of PEPFAR.
In tandem we are also pursuing WHO prequalification for the same products.’’