An Indian company's generic version of a Bristol-Myers Squibb drug used to treat HIV was tentatively approved by the U.S. Food and Drug Administration on Friday for use overseas. The action allows Aurobindo Pharma's version of Sustiva, known chemically as efavirenz, to be used as part of U.S. President George W. Bush's plan to fight AIDS in 15 countries, mostly in Africa.
Health and Human Services Secretary Mike Leavitt said in a statement that the U.S. government was trying to make more drugs available for the President's Emergency Plan for AIDS Relief (PEPFAR).
The five-year, $15 billion program launched in 2003 aims to pay for treatment for 2 million AIDS sufferers and provide care for 10 million others. The tentative approval means the generic drug meets the FDA's safety and efficacy standards but cannot be sold in the United States because of patent or exclusivity constraints. Efavirenz, a type of non-nucleoside reverse transcriptase inhibitor, is used with other antiretroviral drugs to keep the AIDS virus from multiplying. Aurobindo Pharma is based in Ameerpet, Sanjeeva, India.
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