Aurobindo Receives Tentative FDA Approval to Produce Three-Drug Combination Antiretroviral Treatment for PEPFAR

FDA on Friday granted tentative approval to Indian drug manufacturer Aurobindo Pharma to produce a generic pill that combines the antiretroviral drugs lamivudine, zidovidune and nevirapine, VOA News reports (VOA News, 7/2). The tentative approval designation means the 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 (Kaiser Daily HIV/AIDS Report, 6/29). According to FDA, the twice-daily pill might make it easier for people living with HIV/AIDS to adhere to their treatment regimens, the AP/Fox News reports (AP/Fox News, 6/30). The new treatment includes a warning that it might cause liver failure, severe rash or acid build-up in the blood (Reuters, 6/30).

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