Aurobindo Pharma Receives Tentative FDA Approval to Produce Pediatric Version of Generic Antiretroviral Stavudine for PEPFAR
December 22, 2005
FDA on Wednesday granted tentative approval to Indian drug manufacturer Aurobindo Pharma to produce the generic antiretroviral drug stavudine for pediatric use, the AP/Washington Post reports (AP/Washington Post, 12/21). Stavudine, manufactured by Bristol-Myers Squibb under the brand name Zerit, is used in combination with other antiretrovirals to treat HIV infection (Kaiser Daily HIV/AIDS Report, 7/5). The tentative approval designation means the generic drug meets FDA safety and efficacy standards but cannot be sold in the U.S. because of existing patents or exclusivity agreements, although it can be used by relief organizations outside the U.S. under the President's Emergency Plan for AIDS Relief (Xinhuanet, 12/22).
This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.