USFDA gives tentative nod for Ranbaxy drug

Our Corporate Bureau
01 June 2005

New Delhi: Ranbaxy Laboratories has said it has received a tentative approval from the US Food and Drug Administration (USFDA) to manufacture and market Lamivudine tablets (150 mg) in the US, which are used in the treatment of HIV in combination with other anti-retroviral agents.

This is the first product reviewed under the expedited review provisions of the US president's 'emergency plan for AIDS relief' (PEPFAR) Programme. Lamivudine tablets are used in the treatment of HIV infection in combination with other antiretroviral agents.

"We are pleased and proud of our achievement in being granted US FDA tentative approval for Lamivudine. We will continue to add products to this program to help patients afflicted with HIV AIDS," said Brian W Tempest, CEO and managing director, Ranbaxy Laboratories.

This is the first time an Indian company has received approval from the USFDA under its expedited review process to support the US President's Emergency Plan for AIDS Relief Initiative (PEPFAR).

Under the scheme, the US government procures drugs to make affordable medicines available in developing countries facing the AIDS epidemic.

For Ranbaxy getting a tentative nod from the USFDA is an achievement especially since last year, the World Health Organisation had removed Ranbaxy from the list of companies supplying anti-AIDS drugs to it. Since then, the company re-started the process of registering its products with the WHO.