Source facts
FDA issued an approval letter for CARDIOGEN-82 on 2026-05-13. The source metadata identifies NDA 019414 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
CARDIOGEN-82 — FDA Approval Letter (NDA 019414)
Issued to BRACCO. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for CARDIOGEN-82?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 019414.
- 3Submission: supplement.
- 4Sponsor: BRACCO.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the CARDIOGEN-82 approval letter
Is CARDIOGEN-82 FDA approved?
This letter documents an FDA approval action: FDA approved NDA 019414 for CARDIOGEN-82, sponsored by BRACCO, on May 13, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 019414?
NDA 019414 is the application under which FDA issued this approval letter for CARDIOGEN-82 to BRACCO. The letter is dated May 13, 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.