ACTELION: REMS supplement approved for TRACLEER
ACTELION: REMS supplement approved for TRACLEER. Dated 8 days ago, it is in the active follow-up window. Score 65/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 7 published fields of this record are shown below. Locked: 499 related FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | ACTELION |
| Product | TRACLEER |
| Generic / ingredient | BOSENTAN |
| Approval | Drug labeling or REMS supplement |
| Application | NDA021290 supplement 51 |
| Decided | 2026-10-27 |
| Panel / class | TABLET, ORAL |
| Peer records CSV (500 records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-10-27
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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65 / 100 Score
- Decided in the last 30 days.
- New labeling to print and distribute.
What is the FdaApprovalPulse record for ACTELION?
The FDA approved TRACLEER (NDA021290 supplement 51) for ACTELION on 2026-10-27: drug labeling or REMS supplement.
How does ACTELION compare to other FdaApprovalPulse records?
It is fresh: dated 8 days ago, inside the window where early outreach matters most.
ACTELION vs. top 3 peers
Related records
FdaApprovalPulse: Drug labeling or REMS supplement
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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.