← FDA DRUG APPROVALS

FDA NDA · NDA215833

PLUVICTO

lutetium lu 177 vipivotide tetraxetan

Sponsor: NOVARTIS

APPLICATION
NDA215833
TYPE
NDA
ORIGINAL APPROVAL
2022-03-23
LATEST ACTION
2026-04-07
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

PLUVICTO · ReferencePrescription
LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN 27mCi/ML · SOLUTION · INTRAVENOUS

Approval history

2026-04-07Labeling · Supplement 35 · standard — Letter ↗AP
2025-03-28Labeling · Supplement 24 · standard — Label ↗AP
2025-03-28Efficacy · Supplement 21 · standard — Label ↗AP
2022-03-23Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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