Search Orphan Drug Designations and Approvals
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Generic Name: | tazemetostat | ||||||||||||||||
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Trade Name: | |||||||||||||||||
Date Designated: | 06/15/2017 | ||||||||||||||||
Orphan Designation: | Treatment of soft tissue sarcoma | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | tazemetostat |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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