Source facts
FDA issued an approval letter for OGSIVEO on 2026-03-12. The source metadata identifies NDA 217677 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
OGSIVEO — FDA Approval Letter (NDA 217677)
Issued to SPRINGWORKS. Application is approved as submitted.
Issued
March 12, 2026Application
NDA 505b1 • 217677
Product
OGSIVEO
Company
SPRINGWORKS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for OGSIVEO?
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 217677.
- 3Submission: supplement.
- 4Sponsor: SPRINGWORKS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the OGSIVEO approval letter
Is OGSIVEO FDA approved?
This letter documents an FDA approval action: FDA approved NDA 217677 for OGSIVEO, sponsored by SPRINGWORKS, on March 12, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 217677?
NDA 217677 is the application under which FDA issued this approval letter for OGSIVEO to SPRINGWORKS. The letter is dated March 12, 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.