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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Gentamicin impregnated PMMA beads on surgical wire
Date Designated: 01/31/1991
Orphan Designation: Treatment of chronic osteomyelitis of post-traumatic, postoperative, or hematogenous origin.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Lipha Pharmaceuticals, Inc.
9 West 57th Street
Suite 3825
New York, New York 10019
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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