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FDA BLA · BLA761196

ZYNLONTA

loncastuximab tesirine

Sponsor: ADC Therapeutics SA

APPLICATION
BLA761196
TYPE
BLA
ORIGINAL APPROVAL
2021-04-23
LATEST ACTION
2026-02-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ZYNLONTAPrescription
LONCASTUXIMAB TESIRINE-LPYL 10MG · INJECTABLE · INJECTION

Approval history

2026-02-20Labeling · Supplement 13 · standard — Letter ↗AP
2026-01-16Labeling · Supplement 12 · standard — Label ↗AP
2022-10-12Labeling · Supplement 4 · standard — Letter ↗AP
2022-10-12Labeling · Supplement 5 · standard — Letter ↗AP
2021-04-23Type 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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