The Food and Drug Administration within the U.S. Department of Health and Human Services (HHS/FDA) recently announced the tentative approval of zidovudine tablets manufactured by Ranbaxy Laboratories Limited of Guragon, India. This product contains 300 mg of zidovudine in each tablet, and is the first generic version of the already-approved Retrovir brand of the product manufactured by GlaxoSmithKline. Because of the tentative approval by HHS/ FDA, this Ranbaxy generic product will now be available for consideration for purchase and use outside the United States under the President’s Emergency Plan for AIDS Relief.
“This action today by HHS/FDA 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 Murray M. Lumpkin, M.D., Acting Deputy Commissioner (International and Special Programs) at the FDA. “We are especially appreciative of HHS/FDA’s Office of Generic Drugs for the exceptional work they continue to do to help assure that patients this program serves receive medications they can trust and that can indeed help improve the quality of their lives.”
The Emergency Plan for AIDS Relief, which President Bush first announced in his 2003 State of the Union Address, is currently providing $15 billion to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest-hit countries. The President’s Emergency Plan is designed to prevent seven million new HIV infections, treat at least two million HIV-infected people, and care for ten million HIV-affected individuals, AIDS orphans and vulnerable children. It targets three specific areas related to HIV/AIDS:
1. Prevention of HIV transmission;
2. Treatment of AIDS and associated conditions;
3. Care, including palliative care for HIV infected-individuals, and care for orphans and vulnerable children.
Zidovudine is in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which help keep the AIDS virus from reproducing. This anti-retroviral drug is intended to be used with other anti-retroviral agents for the treatment of HIV-1 infection.
The agency’s tentative approval means that although existing patents and/or exclusivity prevent marketing of this product in the United States, it meets all of HHS/FDA’s quality, safety and efficacy standards for U.S. marketing.