The US Food and Drug Administration has tentatively approved two generic versions of Boehringer Ingelheim’s Viramune (nevirapine).

The agency said it was giving the tentative nod to versions of the major drug manufactured by India’s Ranbaxy Laboratories and Aurobindo Pharma. These are the first copycat versions of this product and will now be available under the US Emergency Plan for AIDS Relief, which aims to improve access to essential AIDS therapies in the developing world [[18/05/04e]]. They will not be available for sale in the USA, because Viramune is still patent protected.

The FDA says that the plan is currently providing $15 billion dollars to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest hit countries. It 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.

Viramune belongs to the class of drugs known as non-nucleoside reverse transcriptase inhibitors, which helps keep the AIDS virus from reproducing. It is used in combination with other antiretroviral agents for the treatment of HIV-1 infection. The drug found itself at the centre of a furore in South Africa – the country’s government was forced to supply the product to pregnant women to prevent the transmission of HIV to their babies [[08/07/02a]]. The country’s government had a controversial stance on AIDS and previously said that supplying the drug to all pregnant women with HIV was too expensive [[28/11/01a]].