By regulation, the FDA has 60 days to conduct a filing review to determine if the application is sufficiently complete to permit a substantive review.
Salix has requested Priority Review for this application. By regulation, the FDA should determine the review classification for this application within the 60-day period referenced above.
Xifaxan 550mg is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients = 18 years of age. In the trials of Xifaxan for HE, 91% of the patients were using lactulose concomitantly.
Rifaximin is a gut-selective antibiotic with negligible systemic absorption and broad-spectrum activity in vitro against both gram-positive and gram-negative pathogens. Rifaximin has a similar tolerability profile to that of placebo.
Rifaximin tablets 200mg, which Salix markets in the US under the trade name Xifaxan (rifaximin) tablets 200mg, currently is approved for the treatment of patients, 12 years of age or older, with travelers’ diarrhea (TD) caused by non–invasive strains of Escherichia coli.
Rifaximin is approved in over 30 countries worldwide. Salix acquired rights to market rifaximin in North America from Alfa Wassermann SpA in Bologna, Italy. Alfa Wassermann has marketed Rifaximin in Italy under the trade name Normix for over 20 years.