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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212306
Company: KARYOPHARM THERAPS

Medication Guide

Products on NDA 212306

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212306

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

Labels for NDA 212306

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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