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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
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.
Incyte Corporation
1801 Augustine Cut-Off
Wilmington, Delaware 19803
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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