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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212306
Company: KARYOPHARM THERAPS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XPOVIO SELINEXOR 20MG TABLET;ORAL Prescription None Yes No
XPOVIO SELINEXOR 40MG TABLET;ORAL Prescription None Yes No
XPOVIO SELINEXOR 50MG TABLET;ORAL Prescription None Yes No
XPOVIO SELINEXOR 60MG TABLET;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/03/2019 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212306s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212306Orig1s000rplLTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212306Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/15/2022 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212306s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212306Orig1s011ltr.pdf
03/28/2022 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212306s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212306Orig1s010ltr.pdf
12/18/2020 SUPPL-5 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212306s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212306Orig1s005ltr.pdf
06/22/2020 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212306s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212306Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/15/2022 SUPPL-11 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212306s011lbl.pdf
07/15/2022 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212306s011lbl.pdf
03/28/2022 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212306s010lbl.pdf
12/18/2020 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212306s005lbl.pdf
06/22/2020 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212306s001lbl.pdf
07/03/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212306s000lbl.pdf
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