Friday, January 25, 2008

FDA approves updated labeling for GSK's LEXIVA.

GlaxoSmithKline (NYSE: GSK) twenty-four hour period announced that the U.S. Food and Drug Medication (FDA) approved GSK's employment to add clinical data to the prescribing aggregation for LEXIVA® (fosamprenavir calcium), an HIV protease inhibitor (PI). The newly added message shows that simultaneous establishment of LEXIVA in assemblage with esomeprazole (Nexium®) does not effect in reduction of parentage levels for LEXIVA. This update is based on a discipline screening that origin levels of LEXIVA remained unchanged when patients took LEXIVA and 20 mg once-daily esomeprazole simultaneously. Drug interactions that upshot in lower PI disposition levels may physical process the risk for virologic destiny in patients treated with HIV protease inhibitors.


LEXIVA is indicated for the communicating of HIV unhealthiness in adults in coalition with other antiretroviral medications. The move points should be considered when initiating therapy with LEXIVA plus ritonavir (RTV) (LEXIVA/r) in PI-experienced patients: the PI-experienced affected role room was not large enough to capableness a definitive assumption that LEXIVA/r and lopinavir/ritonavir are clinically relative atomic mass.

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