fluciclovine (18F) 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5153 | 222727-39-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
a radiotracer containing a synthetic amino acid analogue of L-leucine radiolabeled with fluorine F 18 with diagnostic imaging use
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 27, 2016 | FDA | BLUE EARTH DIAGNOSTICS LTD | |
| March 23, 2021 | PMDA | Nihon Medi-Physics Co., Ltd. |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | V09IX12 | VARIOUS DIAGNOSTIC RADIOPHARMACEUTICALS TUMOUR DETECTION Other diagnostic radiopharmaceuticals for tumour detection |
| FDA MoA | N0000175869 | Positron Emitting Activity |
| FDA EPC | N0000177914 | Radioactive Diagnostic Agent |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Positron emission tomography | indication | 82918005 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 2.29 | acidic |
| pKa2 | 8.18 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 9-221mCi/ML | AXUMIN | BLUE EARTH | N208054 | May 27, 2016 | RX | SOLUTION | INTRAVENOUS | 10953112 | Nov. 28, 2026 | METHOD OF DIAGNOSING TUMORS USING POSITRON EMISSION TOMOGRAPHY |
| 9-221mCi/ML | AXUMIN | BLUE EARTH | N208054 | May 27, 2016 | RX | SOLUTION | INTRAVENOUS | 9387266 | Nov. 28, 2026 | METHOD OF DIAGNOSING TUMORS USING POSITRON EMISSION TOMOGRAPHY |
| 9-221mCi/ML | AXUMIN | BLUE EARTH | N208054 | May 27, 2016 | RX | SOLUTION | INTRAVENOUS | 10124079 | Dec. 30, 2035 | POSITRON EMISSION TOMOGRAPHY DIAGNOSTIC AGENT IN ADULTS WITH SUSPECTED PROSTATE CANCER RECURRENCE BASED ON ELEVATED BLOOD PROSTATE SPECIFIC ANTIGEN LEVELS FOLLOWING PRIOR TREATMENT |
| 9-221mCi/ML | AXUMIN | BLUE EARTH | N208054 | May 27, 2016 | RX | SOLUTION | INTRAVENOUS | 10716868 | Dec. 30, 2035 | POSITRON EMISSION TOMOGRAPHY DIAGNOSTIC AGENT IN ADULTS WITH SUSPECTED PROSTATE CANCER RECURRENCE BASED ON ELEVATED BLOOD PROSTATE SPECIFIC ANTIGEN LEVELS FOLLOWING PRIOR TREATMENT |
| 9-221mCi/ML | AXUMIN | BLUE EARTH | N208054 | May 27, 2016 | RX | SOLUTION | INTRAVENOUS | 10933147 | Dec. 30, 2035 | POSITRON EMISSION TOMOGRAPHY DIAGNOSTIC AGENT IN ADULTS WITH SUSPECTED PROSTATE CANCER RECURRENCE BASED ON ELEVATED BLOOD PROSTATE SPECIFIC ANTIGEN LEVELS FOLLOWING PRIOR TREATMENT |
| 9-221mCi/ML | AXUMIN | BLUE EARTH | N208054 | May 27, 2016 | RX | SOLUTION | INTRAVENOUS | 10967077 | Dec. 30, 2035 | POSITRON EMISSION TOMOGRAPHY DIAGNOSTIC AGENT IN ADULTS WITH SUSPECTED PROSTATE CANCER RECURRENCE BASED ON ELEVATED BLOOD PROSTATE SPECIFIC ANTIGEN LEVELS FOLLOWING PRIOR TREATMENT |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| 4039164 | VANDF |
| C1311253 | UMLSCUI |
| CHEBI:134703 | CHEBI |
| CHEMBL254468 | ChEMBL_ID |
| 450601 | PUBCHEM_CID |
| DB13146 | DRUGBANK_ID |
| C117460 | MESH_SUPPLEMENTAL_RECORD_UI |
| 1796118 | RXNORM |
| 241468 | MMSL |
| 31685 | MMSL |
| d08439 | MMSL |
| 016882 | NDDF |
| 457000009 | SNOMEDCT_US |
| 457001008 | SNOMEDCT_US |
| 9243 | INN_ID |
| 38R1Q0L1ZE | UNII |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Axumin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69932-001 | INJECTION, SOLUTION | 221 mCi | INTRAVENOUS | NDA | 26 sections |
| Axumin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69932-001 | INJECTION, SOLUTION | 221 mCi | INTRAVENOUS | NDA | 26 sections |
| Axumin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69932-001 | INJECTION, SOLUTION | 221 mCi | INTRAVENOUS | NDA | 26 sections |