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The Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS) today announced the tentative approval of efavirenz tablets manufactured by Aurobindo Pharma LTD. of Hyderabad, India. This product is the first tentatively approved generic version of Sustiva Tablets (manufactured by Bristol-Myers Squibb). Efavirnez will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).
"HHS and this Administration are working diligently to end the suffering of those with HIV/AIDS. By making these safe and effective treatments available through the PEPFAR program as quickly as possible, we are helping to combat this worldwide problem," said Health and Human Services Secretary Mike Leavitt.
The Emergency Plan for AIDS Relief, which President 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. It targets three specific areas related to HIV/AIDS:
Efavirenz is in the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which helps keep the AIDS virus from reproducing in cells. This antiretroviral drug is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.
The agency's tentative approval means that although existing patents and/or exclusivity prevent marketing of these products in the United States, they meet all of FDA's quality, safety and efficacy standards required for marketing in the United States. More information on HIV and AIDS is available online at FDA's website: http://www.fda.gov/oashi/aids/hiv.html.
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