Indian generic drugmaker Ranbaxy plans to submit three generic HIV antiretroviral drugs to the U.S. Food and Drug Administration by the end of the year so that the medications can be purchased and distributed through the five-year, $15 billion President's Emergency Plan for AIDS Relief. The company also will resubmit the drugs to the World Health Organization by the end of the year for inclusion in WHO's list of prequalified HIV treatments. The generic drugs--two different fixed-dose combinations of 3TC, d4T, and Viramune, and a two-drug combination pill of 3TC and AZT--had been dropped from the WHO list in August after inspections showed labs testing the drugs failed to meet international standards of clinical and laboratory practices.
Ranbaxy hopes the drugs will be available for use in WHO's "three by five" program, which aims to have 3 million HIV-positive people worldwide on antiretroviral therapy by the end of 2005. If approved by the FDA, the drugs also would be available to treat poor HIV-positive people in 15 developing nations through PEPFAR. The federal program to date has refused to buy generic drugs because they haven't been through the rigorous FDA approval process. The generic drugs will not be available in the United States.