Aurobindo receives tentative FDA OK for abacavir sulfate/lamivudine
This article was originally published in Scrip
Executive Summary
Aurobindo Pharmahas received tentative approval from the US FDAto manufacture and market abacavir sulfate/lamivudine tablets 600mg/300mg, a generic version of GlaxoSmithKline's Epzicom tablets. The product was reviewed under the President's emergency plan for AIDS relief (PEPFAR), Aurobindo informed the Bombay Stock Exchange. The product represents Aurobindo's 76th ANDA approval by the FDA.