Tentative approval of lamivudine/zidovudine copackaged with abacavir sulfate
The Food and Drug Administration granted tentative approval on July 26, 2006 for lamivudine/zidovudine tablets, co-packaged with abacavir sulfate tablets, for treatment of HIV, manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India.
The lamivudine/zidovudine combination is a generic formulation of the approved combination product, Combivir, manufactured by GlaxoSmithKline, which combines the two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in a single tablet. Abacavir sulfate, which is also an NRTI, is a generic formulation of the approved product, Ziagen, also manufactured by GlaxoSmithKline. The application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR). "Tentative Approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, though it may not be marketed in the U.S. because of existing patents and/or exclusivity rights. Tentative approval, however, does make the product eligible for consideration for purchase under the PEPFAR program. Richard Klein Office of Special Health Issues Food and Drug Administration Kimberly Struble Division of Antiviral Drug Products Food and Drug Administration