Flutemetamol (18F) Indications/Contra | FAERs | Orange Book | BioActivity |

Stem definitionDrug idCAS RN
4301 765922-62-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • Flutemetamol (18F)
  • 18F-Flutemetamol
  • flutemetamol F 18 injection
  • flutemetamol F 18
  • vizamyl
  • flutemetamol F18
  • flutemetamol F-18
used for PET imaging of brain fibrillar amyloid beta
  • Molecular weight: 273.32
  • Formula: C14H11FN2OS
  • CLOGP: 4.30
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 2
  • TPSA: 45.15
  • ALOGS: -4.31
  • ROTB: 2

Drug dosage:

None

Approvals:

DateAgencyCompanyOrphan
Oct. 25, 2013 FDA GE HEALTHCARE
Sept. 27, 2017 PMDA Nihon Medi-Physics Co Ltd

FDA Adverse Event Reporting System

None

Pharmacologic Action:

SourceCodeDescription
ATC V09AX04 VARIOUS
DIAGNOSTIC RADIOPHARMACEUTICALS
CENTRAL NERVOUS SYSTEM
Other central nervous system diagnostic radiopharmaceuticals
FDA EPC N0000177914 Radioactive Diagnostic Agent
FDA MoA N0000000205 Radiopharmaceutical Activity
CHEBI has role CHEBI:37336 radioactive imaging agent

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Positron emission tomography indication 82918005

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.2 acidic
pKa2 3.58 Basic
pKa3 2.7 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
121.5mCi/30ML (4.05mCi/ML) VIZAMYL GE HEALTHCARE N203137 Oct. 25, 2013 RX INJECTABLE INTRAVENOUS 7351401 Jan. 24, 2023 DIAGNOSTIC RADIOIMAGING
121.5mCi/30ML (4.05mCi/ML) VIZAMYL GE HEALTHCARE N203137 Oct. 25, 2013 RX INJECTABLE INTRAVENOUS 8691185 Jan. 24, 2023 DIAGNOSTIC RADIOIMAGING
40.5mCi/10ML (4.05mCi/ML) VIZAMYL GE HEALTHCARE N203137 Oct. 25, 2013 DISCN INJECTABLE INTRAVENOUS 7351401 Jan. 24, 2023 DIAGNOSTIC RADIOIMAGING
40.5mCi/10ML (4.05mCi/ML) VIZAMYL GE HEALTHCARE N203137 Oct. 25, 2013 DISCN INJECTABLE INTRAVENOUS 8691185 Jan. 24, 2023 DIAGNOSTIC RADIOIMAGING
121.5mCi/30ML (4.05mCi/ML) VIZAMYL GE HEALTHCARE N203137 Oct. 25, 2013 RX INJECTABLE INTRAVENOUS 7270800 Sept. 3, 2025 DIAGNOSTIC RADIOIMAGING
40.5mCi/10ML (4.05mCi/ML) VIZAMYL GE HEALTHCARE N203137 Oct. 25, 2013 DISCN INJECTABLE INTRAVENOUS 7270800 Sept. 3, 2025 DIAGNOSTIC RADIOIMAGING

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
C2983948 UMLSCUI
D10231 KEGG_DRUG
456997008 SNOMEDCT_US
456996004 SNOMEDCT_US
4038255 VANDF
29778 MMSL
d08135 MMSL
1486025 RXNORM
016452 NDDF
L49M066S0O UNII
9169 INN_ID
DB09151 DRUGBANK_ID
CHEBI:76611 CHEBI
CHEMBL2042122 ChEMBL_ID
15950376 PUBCHEM_CID
C581552 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Vizamyl HUMAN PRESCRIPTION DRUG LABEL 1 17156-067 SOLUTION 4.05 mCi INTRAVENOUS NDA 16 sections