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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Roseburia hominis
Date Designated: 08/04/2014
Orphan Designation: Treatment of ulcerative colitis in pediatric patients age 0 through 16 years
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 04/21/2023
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
4D Pharma Research Ltd
Life Sciences Innovation Bldg
Cornhill Road
Scotland
United Kingdom

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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