Good news!
Jan. 26th, 2005 03:56 pm![[personal profile]](https://www.dreamwidth.org/img/silk/identity/user.png){kind=small}
quesarahU.S. Drug Agency Approves Low-Cost, Generic Aids Drugs
United States Department of State (Washington, DC)
PRESS RELEASE
January 26, 2005
Posted to the web January 26, 2005
Washington, DC
Decision could open door to wider availability of drug treatment
The U.S. Food and Drug Administration (FDA) announced January 25 that an AIDS drug manufactured in South Africa meets U.S. standards for quality, safety and efficacy.
The tentative approval means that the cheaper drug, although not eligible for sale in the United States due to patent and/or exclusivity concerns, becomes a suitable candidate for purchase with U.S. aid. Availability of less expensive drugs could allow AIDS-assistance dollars to stretch further, and thus provide treatment for more patients.
FDA review of the foreign-manufactured drug was conducted in order to ensure the drug meets quality, safety and efficacy standards. Only medicines that meet those standards are eligible for purchase with funds provided by the President's Emergency Plan for AIDS Relief. Aspen Pharmacare makes the treatment, which combines three medicines in a one-dose package.
"Through an expedited review process, FDA has worked diligently to approve a product with great public health significance," said Dr. Lester Crawford, acting FDA commissioner. "Our contributions to the goals of the emergency plan are an integral part of that effort."
In a separate press statement, U.S. Global AIDS Coordinator Randall Tobias called the FDA's approval of the generic co-packaged anti-retroviral drug product made in South Africa "another step in ensuring that families throughout the world receive the same quality of drugs that we provide to our own families in the U.S."
Further information about U.S. initiatives on HIV/AIDS is available at http://www.state.gov/s/gac/
United States Department of State (Washington, DC)
PRESS RELEASE
January 26, 2005
Posted to the web January 26, 2005
Washington, DC
Decision could open door to wider availability of drug treatment
The U.S. Food and Drug Administration (FDA) announced January 25 that an AIDS drug manufactured in South Africa meets U.S. standards for quality, safety and efficacy.
The tentative approval means that the cheaper drug, although not eligible for sale in the United States due to patent and/or exclusivity concerns, becomes a suitable candidate for purchase with U.S. aid. Availability of less expensive drugs could allow AIDS-assistance dollars to stretch further, and thus provide treatment for more patients.
FDA review of the foreign-manufactured drug was conducted in order to ensure the drug meets quality, safety and efficacy standards. Only medicines that meet those standards are eligible for purchase with funds provided by the President's Emergency Plan for AIDS Relief. Aspen Pharmacare makes the treatment, which combines three medicines in a one-dose package.
"Through an expedited review process, FDA has worked diligently to approve a product with great public health significance," said Dr. Lester Crawford, acting FDA commissioner. "Our contributions to the goals of the emergency plan are an integral part of that effort."
In a separate press statement, U.S. Global AIDS Coordinator Randall Tobias called the FDA's approval of the generic co-packaged anti-retroviral drug product made in South Africa "another step in ensuring that families throughout the world receive the same quality of drugs that we provide to our own families in the U.S."
Further information about U.S. initiatives on HIV/AIDS is available at http://www.state.gov/s/gac/
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Date: 2005-01-27 01:16 am (UTC)no subject
Date: 2005-01-27 06:08 am (UTC)