Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
Reuters NewMedia - November 30, 2004
The two, lamivudine and lamivudine combined with zidovudine, were returned to the list of WHO approved products after fresh inspections proved they were bioequivalent to their patented counterparts, Jim Kim, director of WHO's HIV department, told a news briefing. "These are two extremely important drugs," Kim said.
With their return, some 50 life-extending antiretroviral drugs are on the list, set up two years ago to guide buying by aid agencies battling the epidemic in Africa and Asia.
Earlier this month, two other Indian firms, Hetero Drugs and Ranbaxy opted to withdraw their generic antiretrovirals following similar concerns about laboratory test findings.
Both concerns say they plan to repeat the studies and resubmit the results for consideration by WHO.
The United Nations agency last August began routine inspections of contract research organizations, independent labs which do bioequivalence testing, the last stage of the lengthy process of approving a product.
The WHO has launched a campaign to get antiretrovirals to three million people in the developing world by the end of 2005. Only 440,000 of the six million AIDS patients are getting them.
The WHO has said that countries should suspend the use of de-listed medicines and switch to other prequalified products.
But if these were difficult to obtain immediately, it was recommended patients continue the use of de-listed products.
041130
RE041165
Copyright © 2004 - Reuters, Ltd. All rights reserved. Republication or redistribution of Reuters content is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Contact Reuters.
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, the National Library of Medicine, Pacific Life Foundation and donations from users like you.
Always watch for outdated information. This article first appeared in 2004. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 2004. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .