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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: sodium fusidate
Date Designated: 10/23/2013
Orphan Designation: Treatment of patients with prosthetic joint infections
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Cempra Pharmaceuticals, Inc.
6340 Quadrangle Drive
Suite 100
Chapel Hill, North Carolina 27517
United States

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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