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XPOVIO (nda212306)- (20MG,40MG,50MG,60MG)

SELINEXOR KARYOPHARM THERAPS
20MG,40MG,50MG,60MG
No No
2035-Aug-14 2024-Jul-03
None None
None No
XPOVIO is a nuclear export inhibitor indicated: • In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. • In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. • For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
0 0 0
Total Other Developers None
Drugs with Suitability No
20MG ** ** - - -
40MG ** ** - - -
50MG ** ** - - -
60MG ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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