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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: retifanlimab-dlwr
Trade Name: Zynyz
Date Designated: 10/26/2020
Orphan Designation: Treatment of Merkel cell carcinoma
Orphan Designation Status: Designated/Approved
Incyte Corporation
1801 Augustine Cut-Off
Wilmington, Delaware 19803
United States

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

Marketing approved:

1 Generic Name: retifanlimab-dlwr
Trade Name: Zynyz
Marketing Approval Date: 03/22/2023
Approved Labeled Indication: treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)
Exclusivity End Date: 03/22/2030 
Exclusivity Protected Indication* :  treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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