Search Orphan Drug Designations and Approvals
-
Generic Name: | rifaximin | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Trade Name: | Xifaxan | ||||||||||||||||
Date Designated: | 02/10/1998 | ||||||||||||||||
Orphan Designation: | Treatment of hepatic encephalopathy | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-