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PEMAZYRE (nda213736)- (4.5MG,9MG,13.5MG)

PEMIGATINIB INCYTE CORP
4.5MG,9MG,13.5MG
No No
2040-Aug-30 2025-Apr-17
None None
None No
PEMAZYRE is a kinase inhibitor 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.
0 0 0
Total Other Developers 3
Drugs with Suitability No
4.5MG ** ** - - -
9MG ** ** - - -
13.5MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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