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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Pemigatinib
Trade Name: PEMAZYRE
Date Designated: 03/12/2018
Orphan Designation: Treatment of cholangiocarcinoma
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: Pemigatinib
Trade Name: PEMAZYRE
Marketing Approval Date: 04/17/2020
Approved Labeled Indication: PEMAZYRE is indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test
Exclusivity End Date: 04/17/2027 
Exclusivity Protected Indication* :  For the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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