23 June, 2005 00:11 GMT
Nevirapine belongs to a class of drugs called non-nucleoside reverse transcriptase inhibitors that help block the HIV reproduction. The safety of the drug -- often used to prevent mother-to-baby transmission of the AIDS virus -- had been disputed due to its side effects.
The United States
Food and Drug Administration (FDA) on Monday tentatively approved two generic versions of Boehringer Ingelheim's nevirapine, enabling use of the HIV drugs under President Bush's Emergency Plan for AIDS Relief.
The first generic versions of nevirapine (Viramune) are produced and sold by Indian companies Ranbaxy Laboratories and Aurobindo Pharma. The FDA said in a statement the products "meet all quality, safety and efficacy standards required for marketing in the United States."
Side-Effects Controversy
However, as the drugs are still patent-protected in the United States, they can be purchased and used in other countries under Bush's plan launched in 2003 to fight AIDS around the world.
The five-year, 15 billion US dollar program is designed to prevent 7 million new HIV infections, treat 2 million HIV-infected people and provide care for 10 million HIV carriers, AIDS orphans and vulnerable children with a focus in 15 countries, mostly in Africa.
Nevirapine belongs to a class of drugs called non-nucleoside reverse transcriptase inhibitors that help block the HIV reproduction. The safety of the drug -- often used to prevent mother-to-baby transmission of the AIDS virus -- had been disputed due to its side effects.
US and international authorities have said nevirapine's benefits outweigh it side effects, including liver damage.
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