Source facts
FDA issued an approval letter for DATSCAN on 2026-04-16. The source metadata identifies NDA 022454 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
DATSCAN — FDA Approval Letter (NDA 022454)
Issued to GE HLTHCARE INC. Application is approved as submitted.
Issued
April 16, 2026Application
NDA 505b1 • 022454
Product
DATSCAN
Company
GE HLTHCARE INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for DATSCAN?
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 022454.
- 3Submission: supplement.
- 4Sponsor: GE HLTHCARE INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the DATSCAN approval letter
Is DATSCAN FDA approved?
This letter documents an FDA approval action: FDA approved NDA 022454 for DATSCAN, sponsored by GE HLTHCARE INC, on April 16, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 022454?
NDA 022454 is the application under which FDA issued this approval letter for DATSCAN to GE HLTHCARE INC. The letter is dated April 16, 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.