 |
 |
 |
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
|
FOR IMMEDIATE RELEASE |
Media
Inquiries: |
The Food and Drug Administration within the U.S. Department of Health and Human Services (HHS/FDA) today announced the tentative approval of the fixed-dose combination drug product lamivudine and zidovudine tablets manufactured by Aurobindo Pharma Ltd. of Hyderabad, India. This fixed-dose combination product contains 150 milligrams of lamivudine and 300 mg of zidovudine in each tablet, and is the first generic version of the already-approved Combivir brand of the product manufactured by GlaxoSmithKline. Because of the tentative approval by HHS/ FDA, this Aurobindo 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 .
"FDA's action underscores our Department's continuing commitment to the patients being served by President Bush's Emergency Plan. We are extremely pleased to have the first generic lamivudine/zidovudine fixed-dose combination product now available for consideration for use in our efforts to make quality AIDS treatments available to patients in the countries aided by the President's Emergency Plan," said Health and Human Services Secretary Mike Leavitt. "This product is a critical part of the arsenal in the global fight against HIV/AIDS."
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:
Lamivudine and zidovudine are in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which help keep the AIDS virus from reproducing. This fixed-dose combination anti-retroviral drug is intended to be used with other antiretroviral 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. More information
on HIV and AIDS is available online at HHS/FDA's
website: http://www.fda.gov/oashi/aids/hiv.html.
####
RSS Feed for FDA News Releases [what's this?]
Get
free weekly updates about FDA press releases, recalls, speeches, testimony
and more.