Summaries of health policy coverage from major news organizations
Aurobindo Pharma Receives Tentative FDA Approval To Produce Three-Drug Combination Pack for PEPFAR
FDA has granted tentative approval to Indian drug manufacturer Aurobindo Pharma to produce a generic, three-drug combination pack of the antiretroviral drugs abacavir, lamivudine and zidovudine, India's Business Standard reports. The combination pack will contain a tablet of 150 mg of lamivudine and 300 mg of zidovudine co-packaged with a 300 mg tablet of abacavir, according to the Business Standard (Business Standard, 8/2). 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 (Kaiser Daily HIV/AIDS Report, 7/13).
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