Tentative approval of co-packaged lamivudine/zidovudine fixed dose combination tablets and nevirapine tablets

Jan 26 2005

The Food and Drug Administration (FDA) has 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.