Source facts
FDA issued an approval letter for KRAZATI on 2026-03-27. The source metadata identifies NDA 216340 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
KRAZATI — FDA Approval Letter (NDA 216340)
Issued to BRISTOL. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for KRAZATI?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 216340.
- 3Submission: supplement.
- 4Sponsor: BRISTOL.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the KRAZATI approval letter
Is KRAZATI FDA approved?
This letter documents an FDA approval action: FDA approved NDA 216340 for KRAZATI, sponsored by BRISTOL, on March 27, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 216340?
NDA 216340 is the application under which FDA issued this approval letter for KRAZATI to BRISTOL. The letter is dated March 27, 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.