Source facts
FDA issued an approval letter for XPOVIO on 2026-05-04. The source metadata identifies NDA 212306 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
XPOVIO — FDA Approval Letter (NDA 212306)
Issued to KARYOPHARM THERAPS. Application is approved as submitted.
Issued
May 4, 2026Application
NDA 505b1 • 212306
Product
XPOVIO
Company
KARYOPHARM THERAPS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for XPOVIO?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 212306.
- 3Submission: supplement.
- 4Sponsor: KARYOPHARM THERAPS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the XPOVIO approval letter
Is XPOVIO FDA approved?
This letter documents an FDA approval action: FDA approved NDA 212306 for XPOVIO, sponsored by KARYOPHARM THERAPS, on May 4, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 212306?
NDA 212306 is the application under which FDA issued this approval letter for XPOVIO to KARYOPHARM THERAPS. The letter is dated May 4, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.