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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: trabectedin
Trade Name: Yondelis
Date Designated: 09/30/2004
Orphan Designation: Treatment of soft tissue sarcoma
Orphan Designation Status: Designated/Approved
Janssen Research & Development, LLC
920 Route 202 South
Raritan, New Jersey 08869
United States

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

Marketing approved:

1 Generic Name: trabectedin
Trade Name: Yondelis
Marketing Approval Date: 10/23/2015
Approved Labeled Indication: For the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen
Exclusivity End Date: 10/23/2022 
Exclusivity Protected Indication* :  For the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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