AEGiS-UPI: HIV-AIDS drug gains tentative FDA approval United Press InternationalImportant note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.
Click here to return to United Press International main menu
DonateNow
Print this article




HIV-AIDS drug gains tentative FDA approval

United Press International - October 29, 2008


WASHINGTON, Oct. 29 (UPI) -- The U.S. Food and Drug Administration has tentatively approved the 75th anti-retroviral generic drug of the president's emergency plan for AIDS relief.

Marketed by Macleods Pharmaceuticals Ltd. of Kachigam, Daman, in India, the FDA said the drug -- generic lamivudine -- is a nucleoside analog reverse-transcriptase inhibitor that blocks an enzyme called reverse transcriptase that's important to human immunodeficiency virus production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop fewer opportunistic infections, the FDA said.

However, the FDA said tentative approval means that although existing patents and/or marketing exclusivity prevent the approval of the product in the United States at this time, the product meets all of the FDA's normal requirements for manufacturing quality, clinical safety and efficacy.


081029
UP081022


Copyright © 2008 - United Press International. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through United Press International, Permissions Desk, 1510 H St. N.W. Washington DC 2005. Main Phone Switchboard: 202-898-8000 FAX: 202-898-8057 or 202-898-8147 Email: info@upi.com.

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from the Elton John AIDS Foundation, National Library of Medicine, and donations from users like you.

Always watch for outdated information. This article first appeared in 2008. 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, 2008. 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. .