← FDA DRUG APPROVALS

FDA NDA · NDA212306

XPOVIO

selinexor

Sponsor: KARYOPHARM THERAPS

APPLICATION
NDA212306
TYPE
NDA
ORIGINAL APPROVAL
2019-07-03
LATEST ACTION
2026-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

XPOVIO · ReferencePrescription
SELINEXOR 10MG · TABLET · ORAL
XPOVIO · ReferencePrescription
SELINEXOR 50MG · TABLET · ORAL
XPOVIO · ReferencePrescription
SELINEXOR 20MG · TABLET · ORAL
XPOVIO · ReferencePrescription
SELINEXOR 80MG · TABLET · ORAL
XPOVIO · ReferencePrescription
SELINEXOR 60MG · TABLET · ORAL
XPOVIO · ReferencePrescription
SELINEXOR 40MG · TABLET · ORAL

Approval history

2026-04-23Efficacy · Supplement 18 · standard — Letter ↗AP
2025-09-26Labeling · Supplement 16 · standard — Label ↗AP
2025-03-10Manufacturing (CMC) · Supplement 13 — Letter ↗AP
2022-07-15Labeling · Supplement 11 · standard — Letter ↗AP
2022-03-28Labeling · Supplement 10 · standard — Letter ↗AP
2020-12-18Efficacy · Supplement 5 · standard — Label ↗AP
2020-06-22Efficacy · Supplement 1 · priority — Label ↗AP
2019-07-03Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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