← FDA DRUG APPROVALS

FDA BLA · BLA761208

TIVDAK

tisotumab vedotin

Sponsor: SEAGEN

APPLICATION
BLA761208
TYPE
BLA
ORIGINAL APPROVAL
2021-09-20
LATEST ACTION
2025-11-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TIVDAKPrescription
TISOTUMAB VEDOTIN-TFTV 40MG · INJECTABLE · INJECTION

Approval history

2025-11-12Labeling · Supplement 10 · standard — Label ↗AP
2024-04-29Efficacy · Supplement 7 · priority — Label ↗AP
2023-07-26Labeling · Supplement 5 · standard — Letter ↗AP
2021-09-20Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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