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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Humanized IgG4 monoclonal antibody against total complement component 1, subcomponent s
Date Designated: 03/28/2018
Orphan Designation: Treatment of immune thrombocytopenia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Recordati Rare Diseases Inc.
440 Route 22 E, Suite 205
Bridgewater, New Jersey 08807
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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