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

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

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Positron emission tomography indication 82918005

Acid dissociation constants calculated using MoKa v3.0.0

None

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 RX INJECTABLE INTRAVENOUS 7351401 Jan. 24, 2023 DIAGNOSTIC RADIOIMAGING
40.5mCi/10ML (4.05mCi/ML) VIZAMYL GE HEALTHCARE N203137 Oct. 25, 2013 RX 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 RX INJECTABLE INTRAVENOUS 7270800 Sept. 3, 2025 DIAGNOSTIC RADIOIMAGING

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
121.5mCi/30ML (4.05mCi/ML) VIZAMYL GE HEALTHCARE N203137 Oct. 25, 2013 RX INJECTABLE INTRAVENOUS Oct. 25, 2018 NEW CHEMICAL ENTITY
40.5mCi/10ML (4.05mCi/ML) VIZAMYL GE HEALTHCARE N203137 Oct. 25, 2013 RX INJECTABLE INTRAVENOUS Oct. 25, 2018 NEW CHEMICAL ENTITY

Bioactivity Summary:

None

External reference:

IDSource
C2983948 UMLSCUI
7342 IUPHAR_LIGAND_ID
D10231 KEGG_DRUG
DB09151 DRUGBANK_ID
CHEMBL2042122 ChEMBL_ID
456996004 SNOMEDCT_US
456997008 SNOMEDCT_US
29778 MMSL
d08135 MMSL
1486025 RXNORM
016452 NDDF
15950376 PUBCHEM_CID
L49M066S0O UNII
C581552 MESH_SUPPLEMENTAL_RECORD_UI
CHEBI:76611 CHEBI

Pharmaceutical products:

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