The Food and Drug Administration yesterday gave tentative approval to the first generic version of the drug AZT, which won FDA approval 18 years ago as the first therapy to prolong the lives of AIDS patients.
The 300-milligram tablets, manufactured by Ranbaxy Laboratories Ltd. of Gurgaon, India, under the generic name zidovudine, cannot be marketed for now in the United States because of patent restrictions.
But the FDA approved the generic drug as safe and effective, allowing it to be sold in two years when the patent expires.
The drug “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,” the FDA said.
“This action today … adds yet another valuable product to the growing list of effective and safe quality medicines available for consideration for purchase under the president’s emergency plan,” said Dr. Murray M. Lumpkin, the FDA’s acting deputy commissioner for international and special programs.
The President’s Emergency Plan for AIDS Relief, which President Bush announced in his 2003 State of the Union address, is providing $15 billion over five years, with a special focus on 15 of the world’s hardest-hit nations, including South Africa, Zimbabwe and India.
Martin Delaney, director of Project Inform, a San Francisco-based group involved in efforts to get effective AIDS medications to needy patients, said the FDA’s action yesterday “creates the chance for the U.S. program to get this drug more cheaply for use in Third World countries.”
AZT or azidothymidine (trade name Retrovir), was approved by the FDA in March 1987. Approval came several months after a clinical trial of the drug in AIDS patients was cut short when patients on placebos were found to be dying at a far higher rate than those on AZT.
At that time, the anti-retroviral therapy was manufactured by Burroughs Welcome Co. But drug giant GlaxoSmithKline eventually acquired the drug and the patent rights after a series of business moves, which included buying Burroughs Welcome.
Mr. Delaney also noted that the patent rights GlaxoSmithKline now holds on Retrovir are “running out,” which means generic versions of the famous HIV therapy can be sold in this country in the future.
The FDA says the zidovudine tablets are the 10th product for which the agency has given either full or tentative approval for use in association with the president’s emergency AIDS plan. One product has been given full approval while nine have been tentatively approved.