Source facts
FDA issued an approval letter for TRACLEER on 2026-03-04. The source metadata identifies NDA 021290, NDA 209279 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
TRACLEER — FDA Approval Letter (NDA 021290)
Issued to ACTELION. Application is approved as submitted.
Assyro regulatory brief
FreeWhat did FDA decide for TRACLEER?
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.
- 2Applications: NDA 021290, NDA 209279.
- 3Submission: supplement.
- 4Sponsor: ACTELION.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the TRACLEER approval letter
Is TRACLEER FDA approved?
This letter documents an FDA approval action: FDA approved NDA 021290 for TRACLEER, sponsored by ACTELION, on March 4, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 021290?
NDA 021290 is the application under which FDA issued this approval letter for TRACLEER to ACTELION. The letter is dated March 4, 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.