SEAGEN: efficacy supplement approved for TUKYSA
SEAGEN: efficacy supplement approved for TUKYSA. Dated 28 days ago, it is in the active follow-up window. Score 75/100. 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 | SEAGEN |
| Product | TUKYSA |
| Generic / ingredient | TUCATINIB |
| Approval | Drug efficacy supplement (new indication or use) |
| Application | NDA213411 supplement 10 |
| Decided | 2026-10-07 |
| Panel / class | TABLET, ORAL |
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| 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: 2026-10-07
- 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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75 / 100 Score
- Decided in the last 30 days.
- New indication or use: a relaunch.
What is the FdaApprovalPulse record for SEAGEN?
The FDA approved TUKYSA (NDA213411 supplement 10) for SEAGEN on 2026-10-07: drug efficacy supplement (new indication or use).
How does SEAGEN compare to other FdaApprovalPulse records?
It is 28 days old, still within a typical 45-day follow-up window. Its Score of 75/100 puts it among the stronger signals in this feed.
SEAGEN vs. top 3 peers
| Organization | Record date |
|---|---|
| SEAGEN | 2026-10-07 |
| SUN PHARMA GLOBAL | 2026-10-29 |
| PFIZER | 2026-10-26 |
| PFIZER | 2026-10-26 |
Related records
FdaApprovalPulse: Drug efficacy supplement (new indication or use)
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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.