← FDA DRUG APPROVALS

FDA NDA · NDA203137

VIZAMYL

flutemetamol f-18

Sponsor: GE HEALTHCARE

APPLICATION
NDA203137
TYPE
NDA
ORIGINAL APPROVAL
2013-10-25
LATEST ACTION
2025-06-23
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

VIZAMYL · ReferencePrescription
FLUTEMETAMOL F-18 121.5mCi/30ML (4.05mCi/ML) · INJECTABLE · INTRAVENOUS
VIZAMYL · ReferenceDiscontinued
FLUTEMETAMOL F-18 40.5mCi/10ML (4.05mCi/ML) · INJECTABLE · INTRAVENOUS

Approval history

2025-06-23Efficacy · Supplement 24 · standard — Letter ↗AP
2025-06-10Labeling · Supplement 32 · standard — Label ↗AP
2020-01-10Labeling · Supplement 13 · standard — Letter ↗AP
2017-02-22Labeling · Supplement 8 · standard — Letter ↗AP
2016-11-21Manufacturing (CMC) · Supplement 6 · standardAP
2016-06-07Manufacturing (CMC) · Supplement 3 · standardAP
2016-04-07Labeling · Supplement 5 · standard — Letter ↗AP
2015-02-03Manufacturing (CMC) · Supplement 1 · standardAP
2014-12-04Labeling · Supplement 2 · standard — Letter ↗AP
2013-10-25Type 1 - New Molecular Entity · Original · standard — Review ↗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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