SLXP - Salix Pharmaceuticals Ltd. Gets FDA Approval For XIFAXAN®
RALEIGH, N.C.--(BUSINESS WIRE)--Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the U.S. Food and Drug Administration (FDA) has granted marketing approval for XIFAXAN® (rifaximin) 550 mg tablets for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients 18 years of age or older.
HE is a serious disorder caused by chronic liver failure, resulting in cognitive, psychiatric and motor impairments. This approval was supported by findings from the largest randomized trial of maintenance therapy in HE conducted to date, which assessed the efficacy and safety of XIFAXAN 550 mg tablets and demonstrated a statistically significant and clinically meaningful reduction in the risk of overt HE recurrence.ii The labeling for XIFAXAN 550 mg tablets includes data on both the risk reduction of overt HE recurrence as well as risk reduction of HE-related hospitalization.
http://finance.yahoo.com/news/FDA-Approves-XIFAXAN-550-MG-bw-3571437432.html?x=0&.v=1
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