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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: siltuximab
Trade Name: SYLVANT
Date Designated: 05/26/2006
Orphan Designation: Treatment of Castleman's disease
Orphan Designation Status: Designated/Approved
Recordati Rare Diseases Inc.
440 Route 22 East
Bridgewater, New Jersey 08807
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: siltuximab
Trade Name: SYLVANT
Marketing Approval Date: 04/23/2014
Approved Labeled Indication: Treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.
Exclusivity End Date: 04/23/2021 
Exclusivity Protected Indication* :  Treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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