Salix submits efficacy supplement for XIFAXAN NDA for Non-C IBS and IBS-related bloating

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company has submitted an efficacy supplement to NDA 21-361 for XIFAXAN® (rifaximin) 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating. By regulation, the Food and Drug Administration (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.

Source:

Salix Pharmaceuticals, Ltd.,

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post
You might also like...
What is the efficacy of the BCG vaccine against SARS-CoV-2 infection?