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Policy & Politics
Aurobindo Pharma Receives Tentative FDA Approval to Produce Generic Antiretroviral Stavudine for PEPFAR

July 5, 2005

FDA on Friday granted tentative approval to Indian drug manufacturer Aurobindo Pharma to produce the generic antiretroviral stavudine for use under the President's Emergency Plan for AIDS Relief, Reuters reports. Stavudine, manufactured by Bristol-Myers Squibb under the brand name Zerit, is used in combination with other antiretrovirals to treat HIV infection (Reuters, 7/1). HHS in May 2004 announced plans for a new FDA fast-track review program to speed the delivery of low-cost antiretroviral drugs -- including fixed-dose combination drugs -- to nations covered under PEPFAR. The expedited process is meant to encourage drug makers to produce generic medications to improve access to drugs in remote areas of severely affected countries and ensure the drugs' safety (Kaiser Daily HIV/AIDS Report, 6/21). The tentative approval designation means the generic drug meets FDA safety and efficacy standards but cannot be sold in the United States because of existing patents or exclusivity agreements. HHS Secretary Mike Leavitt said in a statement, "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," adding, "Stavudine is another treatment in the expanding arsenal in the global fight against AIDS" (FDA release, 7/1).

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