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.
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
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.
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).
the scheme, the US government procures drugs to make affordable medicines
available in developing countries facing the AIDS epidemic.
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.
is one of the four companies identified by the Bill Gates Foundation to supply
ARVs for its anti-AIDS campaign in the developing countries.