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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 the version of Stavudine Capsules manufactured by Aurobindo Pharma LTD. Hyderabad, India. The Aurobindo version of Stavudine is the first generic version of the already approved Zerit capsules brand of Stavudine manufactured by Bristol-Myers Squibb. Because of its tentative approval by FDA, this Aurobindo generic version will now be available for consideration for purchase and use outside the United States under the President’s Emergency Plan for AIDS Relief (PEPFAR).
“We are pleased to announce another completed drug review by HHS and the Administration in our continuing efforts to make available safe and effective AIDS treatments, “ said Health and Human Services Secretary Mike Leavitt. “Stavudine is another treatment in the expanding arsenal in the global fight against AIDS.”
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 President’s Emergency 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:
Stavudine is in the class of drugs called Nucleoside Reverse Transcripts Inhibitors (NRTIs). NRTIs help keep the AIDS virus from reproducing. Stavudine 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 U.S., they meet all of FDA’s quality, safety and efficacy standards. 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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