[en attendant la traduction!CB]
Vers l'autorisation d'une association antirétrovirale du sud-africain
Aspen Pharmacare aux Etats-Unis
http://www.fda.gov/bbs/topics/news/2005/NEW01152.html
FDA News
FOR IMMEDIATE RELEASE
P05-02
January 25, 2005
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
FDA Grants Tentative Approval to Generic AIDS Drug Regimen for Potential
Purchase Under the President's Emergency Plan for AIDS Relief
The Food and Drug Administration (FDA) today announced the tentative
approval of a co-packaged antiretroviral drug regimen manufactured by
Aspen Pharmacare of South Africa for the treatment of HIV-1 infection in
adults. The agency's tentative approval means that although existing
patents and/or exclusivity prevent U.S. marketing of Aspen's product, it
meets FDA's quality, safety and efficacy standards for U.S. marketing.
This action makes this product available for potential procurement by
President Bush's Emergency Plan for AIDS Relief.
Today's action is the first tentative approval of an HIV drug regimen
manufactured by a non-U.S.-based generic pharmaceutical company. Once
Aspen 's marketing application was complete on January 13, 2005, FDA
completed its review within two weeks.
"Today's action honors the commitment of the Department of Health and
Human Services and Secretary Thompson to the President's Emergency Plan
for AIDS Relief," said Dr. Lester M. Crawford, Acting FDA Commissioner.
"The goal of the emergency plan is to make safe, effective and
affordable quality drugs available quickly for patients with HIV/AIDS."
"Through an expedited review process, FDA has worked diligently to
approve a product with great public health significance. Our
contributions to the goals of the emergency plan are an integral part of
that effort," added Dr. Crawford.
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. It targets three specific
areas related to HIV/AIDS:
Prevention of HIV transmission;
Treatment of AIDS and associated conditions;
Care, including palliative care for HIV infected-individuals, and care
for orphans and vulnerable children.
The tentatively approved regimen consists of co-packaged
lamivudine/zidovudine fixed dose combination tablets and nevirapine
tablets. Lamivudine/zidovudine fixed dose combination tablets are a
version of the already approved Combivir tablets manufactured by
GlaxoSmithKline, and nevirapine tablets are a version of Viramune
tablets manufactured by Boehringer-Ingelheim. The new co-packaged
product consists of two tablets (lamivudine/zidovudine and nevirapine)
each to be taken twice daily, after the initial two-week initiation
phase of this nevirapine regimen.
More information on HIV and AIDS is available online at FDA's website:
http://www.fda.gov/oashi/aids/hiv.html.