FDA Approves Updated Labeling for LEXIVA 18.11.2005 15:02:00
CAMBRIDGE, Mass. and RTP, N.C., Nov. 18 /PRNewswire-FirstCall/ -- GlaxoSmithKline and Vertex Pharmaceuticals Incorporated today announced that the U.S. Food and Drug Administration (FDA) approved GSK's application to add clinical data to the prescribing information for LEXIVA(R) (fosamprenavir calcium), an HIV protease inhibitor (PI). The newly added information shows that simultaneous administration of LEXIVA in combination with esomeprazole (Nexium(R)) does not result in lowering of blood levels for LEXIVA. This update is based on a study showing that blood levels of LEXIVA remained unchanged when patients took LEXIVA and 20 mg once-daily esomeprazole simultaneously. Drug interactions that result in lower PI blood levels may increase the risk for virologic failure in patients treated with HIV protease inhibitors.