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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: tazemetostat
Trade Name:
Date Designated: 06/15/2017
Orphan Designation: Treatment of soft tissue sarcoma
Orphan Designation Status: Designated/Approved
Epizyme, Inc.
400 Technology Square
4th Floor
Cambridge, Massachusetts 02139
United States

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

Marketing approved:

1 Generic Name: tazemetostat
Trade Name:
Marketing Approval Date: 01/23/2020
Approved Labeled Indication: TAZVERIK is indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Exclusivity End Date: 01/23/2027 
Exclusivity Protected Indication* :  

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.