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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: rifaximin
Trade Name: Xifaxan
Date Designated: 02/10/1998
Orphan Designation: Treatment of hepatic encephalopathy
Orphan Designation Status: Designated/Approved
Salix Pharmaceuticals, Inc.
400 Somerset Corporate Blvd
Somerset, New Jersey 08807
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: rifaximin
Trade Name: Xifaxan
Marketing Approval Date: 03/24/2010
Approved Labeled Indication: Reduction in the risk of overt hepatic encephalopathy (HE) recurrence in patients greater than or equal to 18 years of age
Exclusivity End Date: 03/24/2017 
Exclusivity Protected Indication* :  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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