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Ranbaxy gets tentative USFDA nod for AIDS drug Lamivudine

Our Bureau

New Delhi , May 31

RANBAXY Laboratories Ltd (RLL) on Tuesday announced that it has received a tentative approval to manufacture and market Lamivudine tablets, 150 mg, from the US Food and Drug Administration.

This is Ranbaxy's and India's first tentative approval from the USFDA under its expedited review process to support Pepfar (President's emergency plan for AIDS relief).

In combination with other anti retroviral agents (ARVs), Lamivudine tablets are indicated for the treatment of HIV infection.

Pepfar is a US Government HIV/AIDS initiative with an aim to achieving the goal of treating at least two million people with anti-retroviral therapy, preventing seven million new infections, and caring for 10 million persons infected with and affected by HIV.

The emergency plan focuses its efforts in 15 countries in Africa, Asia and the Caribbean.

All Ranbaxy ARVs, including Lamivudine 150mg, are manufactured at the company's manufacturing facilities and inspected and approved by some of the most stringent agencies in the world, including the USFDA.

Commenting on this development, Dr Brian W. Tempest, CEO and Managing Director, RLL, 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 pre-qualification for the same products."

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