FDA to Allow Generic Version of Life-Prolonging AIDS Drug

On Wednesday, the Food and Drug Administration gave tentative approval to the first generic version of AZT, which the agency approved 18 years ago as the first antiretroviral to treat HIV. The 300-milligram tablets, manufactured by India's Ranbaxy Laboratories Ltd. under the name zidovudine, cannot be marketed in the United States due to patent restrictions.

But FDA approved zidovudine as safe and effective, allowing it to be sold in two years when the patent expires. FDA said zidovudine "meets all of FDA's quality, safety and efficacy standards for U.S. marketing" and "will now be available for consideration for purchase and use outside the United States under the President's Emergency Plan for AIDS Relief [PEPFAR]."

Martin Delaney, director of ProjectInform, a San Francisco-based group involved in efforts to get effective HIV/AIDS medications to needy patients, said FDA's action "creates the chance for the U.S. program to get this drug more cheaply for use in Third World countries."

FDA says zidovudine is the tenth product for which the agency has given either full or tentative approval for use in association with PEPFAR, a $15 billion, five-year program to fight HIV/AIDS in 15 hard-hit nations. One product has been granted full approval; the other nine have tentative approval.

AZT gained FDA approval in March 1987, several months after an AZT trial was cut short when patients on placebos were found to be dying at a far higher rate than those on AZT. At the time, Burroughs Welcome Co. manufactured AZT. Currently, GlaxoSmithKline manufactures the drug and holds the patent rights.

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