Flutemetamol (18F) Indications/Contra | FAERs | Orange Book | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4301 | 765922-62-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
used for PET imaging of brain fibrillar amyloid beta
|
Drug dosage:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 25, 2013 | FDA | GE HEALTHCARE | |
| Sept. 27, 2017 | PMDA | Nihon Medi-Physics Co Ltd |
FDA Adverse Event Reporting System
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Positron emission tomography | indication | 82918005 |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.2 | acidic |
| pKa2 | 3.58 | Basic |
| pKa3 | 2.7 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Vizamyl | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17156-067 | SOLUTION | 4.05 mCi | INTRAVENOUS | NDA | 16 sections |