Source facts
FDA issued an approval letter for VANFLYTA on 2026-05-01. The source metadata identifies NDA 216993 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
VANFLYTA — FDA Approval Letter (NDA 216993)
Issued to DAIICHI SANKYO INC. Application is approved as submitted.
Issued
May 1, 2026Application
NDA 505b1 • 216993
Product
VANFLYTA
Company
DAIICHI SANKYO INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for VANFLYTA?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 216993.
- 3Submission: supplement.
- 4Sponsor: DAIICHI SANKYO INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the VANFLYTA approval letter
Is VANFLYTA FDA approved?
This letter documents an FDA approval action: FDA approved NDA 216993 for VANFLYTA, sponsored by DAIICHI SANKYO INC, on May 1, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 216993?
NDA 216993 is the application under which FDA issued this approval letter for VANFLYTA to DAIICHI SANKYO INC. The letter is dated May 1, 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.