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KYPROLIS (nda202714)- (10MG/VIAL,30MG/VIAL,60MG/VIAL)

CARFILZOMIB ONYX PHARMS AMGEN
10MG/VIAL,30MG/VIAL,60MG/VIAL
Yes No
2033-Feb-27 2017-Jul-20
2019-Jul-20 None
None No
Kyprolis is a proteasome inhibitor that is indicated: • for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy in combination with o Lenalidomide and dexamethasone; or o Dexamethasone; or o Daratumumab and dexamethasone; or o Daratumumab and hyaluronidase-fihj and dexamethasone; or o Isatuximab and dexamethasone. • as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
1 3 0
Total Other Developers 18
Drugs with Suitability No
10MG/VIAL ** ** - - -
30MG/VIAL ** ** - - -
60MG/VIAL ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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