Several AIDS Drugs Tentatively Approved
Posted on: Wednesday, 21 September 2005, 03:01 CDT
The FDA has tentatively approved several generic AIDS drugs under a relief plan intended to target prevention, treatment, and care programs to countries that are among the most afflicted by the disease.
Since June 2005, a half dozen drug applications have received tentative FDA approval, meaning that the products will now be available for consideration for purchase and use outside the United States under the President's Emergency Plan for AIDS Relief (PEPFAR). The plan, which President Bush first announced in his 2003 State of the Union Address, is providing $15 billion to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest-hit countries. The PEPFAR plan is designed to prevent 7 million new HIV infections, treat at least 2 million HIV-infected people, and care for 10 million people infected and affected by HIV/ AIDS, including orphans and other children who are vulnerable.
The FDA's tentative approval of these drugs means that although existing patents and exclusivity prevent them from being marketed in the United States, the drugs meet all the FDA's quality, safety, and effectiveness standards required for marketing in this country. See www.fda.gov/oashi/aids/hiv. html for more information on HIV/ AIDS and the drugs used to treat the disease.
Copyright Superintendent of Documents Sep/Oct 2005
Source: FDA Consumer
Related Articles
- Medicare Prescription Drug Plans Not Fully Compliant With Federal Regulations, According to Tufts Center for the Study of Drug Development
- GAO to Enquire into FDA's Drug Approval Policies
- FDA: New Merck HIV-Fighting Drug Is Safe
- More Methadone Clinics Built in China to Curtail AIDS/HIV Spreading
- China Spends More on AIDS/HIV Prevention, Control
- Computer Program to Aid Hunt for Drug Plan
- Aetna Announces Alliance With Standard Life to Market Medicare Prescription Drug Plans; Consumers to Have Local Access to the Plans Through Independent Agents
- Medicare Drug Plans to Be Unveiled Next Month
- Senators Hone Medicare Drug Plan
- Senators Close Gaps in Medicare Drug Plan
 |
 |
User Comments (0)
RSS Feeds