Ranbaxy receives tentative FDA approval to manufacture and market Zidovudine tablets

Jul 15 2005

India's Ranbaxy Laboratories has announced that it has received tentative approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Zidovudine Tablets USP, 300 mg.

This is the first approval granted by the USFDA for generic Zidovudine. This is also Ranbaxy's third tentative approval from the USFDA under the latter's expedited review process under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). Zidovudine Tablets are indicated for use in combination with other antiretroviral (ARV) agents in the treatment of HIV infection.

Ranbaxy's Zidovudine Tablets are manufactured at the company's state-of- the-art manufacturing facilities that have also been approved by the USFDA. The Contract Research Organizations (CROs) used by Ranbaxy to carry out bio- equivalence studies for its ARVs are audited by, and file their studies routinely with, some of the most stringent regulatory authorities around the world.

Commenting on this development, Dr. Brian W. Tempest, CEO and Managing Director, RLL, said, "We are committed to making quality ARVs available to HIV/AIDS patients throughout the world. We are pleased with the speed with which USFDA has moved in approving our products and will continue to work with them for the approval of our remaining ARVs in support of PEPFAR. Simultaneously, we are extending full cooperation to WHO, so that they can also approve the same products under their pre-qualification program."

Generic ARVs are essential to winning the worldwide struggle against HIV/AIDS, an epidemic now infecting approximately 40 million people around the globe. More than 20 million individuals have so far succumbed to this devastating disease.