Vizamyl

Used in scans for cognitive impairment. NDA 203137, held by Ge Healthcare. Flutemetamol F-18.

As of Nov 13, 2026, NDA 203137 (Vizamyl), held by Ge Healthcare, was first approved by FDA on Oct 25, 2013, with 9 approved supplements and 0 published complete response letters.

First approved: Oct 25, 2013
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

VIZAMYL is indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer's disease (AD) and other causes of cognitive decline Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below


Jun 23, 2025	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 25, 2013	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Products

2 strengths and forms


Vizamyl40.5mCi/10ML (4.05mCi/ML) · injectable;intravenous	Flutemetamol F-18	DiscontinuedReference drug
Vizamyl121.5mCi/30ML (4.05mCi/ML) · injectable;intravenous	Flutemetamol F-18	RxReference drug

All 10 submissions, including labeling and manufacturing supplements


Jun 23, 2025	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 10, 2025	Supplement 32Labeling · Standard review	Approved	Letter Label
Jan 10, 2020	Supplement 13Labeling · Standard review	Approved	Letter Label
Feb 22, 2017	Supplement 8Labeling · Standard review	Approved	Letter Label
Nov 21, 2016	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 7, 2016	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 7, 2016	Supplement 5Labeling · Standard review	Approved	Letter Label
Feb 3, 2015	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 4, 2014	Supplement 2Labeling · Standard review	Approved	Label Letter
Oct 25, 2013	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 203137
Drugs@FDA: Overview at FDA
Company: GE Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters