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South Africa may ban common anti-HIV drug

South Africa may ban common anti-HIV drug

South Africa will ban the AIDS drug Viramune unless manufacturers can provide new data to prove its safety, officials announced Wednesday. Viramune, one of the world's most commonly used anti-HIV drugs to help block mother-to-child transmissions, was the first antiretroviral drug approved for use in South Africa last year after activists won a court order forcing the government to provide it to HIV-positive mothers. About 100,000 HIV-positive babies are born every year in South Africa. South Africa's Medicines Control Council told German drug manufacturer Boehringer Ingelheim that because of procedural flaws it had rejected a 1999 Ugandan study used to demonstrate Viramune's effectiveness in blocking mother-to-child transmissions. MCC chief Precious Matsoso said unless the company provided additional safety and effectiveness data within 90 days, the government would revoke the drug's temporary approval. Boehringer spokesperson Kevin McKenna said the company had already submitted all available data to MCC. "We shall continue to try to work with the MCC to clarify these technical problems," McKenna said. "But it will be very difficult for us to produce that evidence. There are no other studies. There is no other information available." The U.S. government raised similar doubts about the Ugandan study last year. Boehringer Ingelheim has since dropped an application to have Viramune approved for mother-to-child use in the United States.

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