Summaries of health policy coverage from major news organizations
Aurobindo Pharma Receives Tentative FDA Approval To Produce Generic Antiretroviral Efavirenz for PEPFAR
FDA on Friday granted tentative approval to Indian drug manufacturer Aurobindo Pharma to produce the generic antiretroviral efavirenz for use under the President's Emergency Plan for AIDS Relief, Reuters reports. Efavirenz, manufactured by Bristol-Myers Squibb under the brand name Sustiva, is used in combination with other antiretrovirals to treat HIV infection (Reuters, 6/24). 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 it cannot be sold in the United States because of existing patents or exclusivity agreements (Reuters, 6/24). HHS Secretary Mike Leavitt said in a statement that the government is "working diligently to end the suffering of those with HIV/AIDS," adding, "By making these safe and effective treatments available through the PEPFAR program as quickly as possible, we are helping to combat this worldwide problem" (FDA release, 6/24).
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