← FDA DRUG APPROVALS

FDA NDA · NDA213702

ZEPZELCA

lurbinectedin

Sponsor: JAZZ

APPLICATION
NDA213702
TYPE
NDA
ORIGINAL APPROVAL
2020-06-15
LATEST ACTION
2026-02-27
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ZEPZELCA · ReferencePrescription
LURBINECTEDIN 4MG/VIAL · POWDER · INTRAVENOUS

Approval history

2026-02-27Labeling · Supplement 12 · standard — Letter ↗AP
2025-10-02Efficacy · Supplement 11 · priority — Label ↗AP
2025-04-30Labeling · Supplement 10 · standard — Letter ↗AP
2023-07-28Labeling · Supplement 8 · standard — Label ↗AP
2022-04-01Labeling · Supplement 4 · standard — Letter ↗AP
2020-06-15Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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