Hardbeatnews, WASHINGTON, D.C., Fri. June 24, 2005: Caribbean and other victims of the deadly AIDS disease may soon be able to benefit from two other drugs used in to help stem the disease.
The US Food and Drug Administration this week announced that for the first time it was giving the tentative approval to nevirapine tablets manufactured by Ranbaxy Laboratories Limited, Guragon, India and Aurobindo Pharma Limited of Hyderabad, India.
Nevirapine is in the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which helps keep the AIDS virus from reproducing. The tentative approval means the drug meets FDA norms for efficacy, safety and quality, and can be part of the US President's program to supply low-cost AIDS drugs to the poorest and developing countries. As such, they are now eligible to be considered for purchase and use outside US.
"These are the first generic versions of Viramune Tablets manufactured by Boehringer Ingelheim. These products will now be available for consideration for purchase under the president's emergency plan for AIDS relief," an FDA official said.
The Emergency Plan for AIDS Relief, which President George 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.
The PEPFAR plan is designed to prevent seven million new HIV infections, treat at least two million HIV-infected people, and care for ten million HIV-affected individuals, AIDS orphans and vulnerable children.
The agency's tentative approval means that although existing patents and/or exclusivity prevent the marketing of Aurobindo's and Ranbaxy's products in the United States, these products meet all of FDA's quality, safety and efficacy standards required for marketing in the United States. As such, they are now eligible to be considered for purchase and use outside the United States. – Hardbeatnews.com
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