FDA OKs 3-Drug Combo Pill to Treat HIV
Posted on: Friday, 30 June 2006, 18:00 CDT
WASHINGTON - The first three-drug combination pill to treat HIV as part of foreign AIDS relief efforts won federal approval Friday.
The twice-daily pills combine three drugs already widely used to treat human immunodeficiency virus: lamivudine, zidovudine and nevirapine. The generic pill is made by India's Aurobindo Pharma Ltd.
The pills cannot be sold in the United States for patent and/or exclusivity reasons, although they meet all U.S. standards for safety and efficacy, according to the Food and Drug Administration. The pills are eligible for distribution in 15 other countries under the President's Emergency Plan for AIDS Relief, or PEPFAR.
President Bush unveiled the program in 2003.
Combining multiple drugs in a single pill should help HIV-positive adults maintain a treatment regimen - something that is more difficult when several drugs must be taken individually each day, according to the FDA.
The FDA has approved more than 20 treatments for distribution under PEPFAR.
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On the Net:
Food and Drug Administration: http://www.fda.gov/
U.S. Global AIDS Coordinator: http://www.state.gov/s/gac/
Source: Associated Press/AP Online
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