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| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5861 | 863887-89-2 |
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 27, 2024 | FDA | GE HealthCare |
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| Source | Code | Description |
|---|---|---|
| ATC | V09GX06 | VARIOUS DIAGNOSTIC RADIOPHARMACEUTICALS CARDIOVASCULAR SYSTEM Other cardiovascular system diagnostic radiopharmaceuticals |
| FDA MoA | N0000175869 | Positron Emitting Activity |
| FDA EPC | N0000177914 | Radioactive Diagnostic Agent |
| CHEBI has role | CHEBI:35554 | cardiovascular drug |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Positron emission tomography for myocardial perfusion imaging | indication | 82918005 |
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| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 5-55mCi/ML | FLYRCADO | GE HLTHCARE | N215168 | Sept. 27, 2024 | RX | SOLUTION | INTRAVENOUS | 9161997 | Feb. 4, 2026 | METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) FOR CARDIAC IMAGING |
| 5-55mCi/ML | FLYRCADO | GE HLTHCARE | N215168 | Sept. 27, 2024 | RX | SOLUTION | INTRAVENOUS | 8226929 | June 21, 2028 | METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) FOR CARDIAC IMAGING |
| 5-55mCi/ML | FLYRCADO | GE HLTHCARE | N215168 | Sept. 27, 2024 | RX | SOLUTION | INTRAVENOUS | 9603951 | May 2, 2031 | METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) FOR CARDIAC IMAGING |
| 5-55mCi/ML | FLYRCADO | GE HLTHCARE | N215168 | Sept. 27, 2024 | RX | SOLUTION | INTRAVENOUS | 8936777 | June 30, 2031 | METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) FOR CARDIAC IMAGING |
| 5-55mCi/ML | FLYRCADO | GE HLTHCARE | N215168 | Sept. 27, 2024 | RX | SOLUTION | INTRAVENOUS | 9687571 | Nov. 1, 2032 | METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) FOR CARDIAC IMAGING |
| 5-55mCi/ML | FLYRCADO | GE HLTHCARE | N215168 | Sept. 27, 2024 | RX | SOLUTION | INTRAVENOUS | 12527884 | May 13, 2042 | METHOD OF POSITRON EMISSION TOMOGRAPHY (PET) FOR CARDIAC DISEASES |
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 5-55mCi/ML | FLYRCADO | GE HLTHCARE | N215168 | Sept. 27, 2024 | RX | SOLUTION | INTRAVENOUS | Sept. 27, 2029 | NEW CHEMICAL ENTITY |
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Mitochondrial complex I (NADH dehydrogenase) | Enzyme | OTHER | IC50 | 7.78 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| CHEMBL2107799 | ChEMBL_ID |
| C525920 | MESH_SUPPLEMENTAL_RECORD_UI |
| C5419355 | UMLSCUI |
| CHEBI:752868 | CHEBI |
| 9248 | INN_ID |
| 11405965 | PUBCHEM_CID |
| TY3V24C029 | UNII |
| 2700762 | RXNORM |
| D10009 | KEGG_DRUG |
| 389546 | MMSL |
| 43227 | MMSL |
| d10225 | MMSL |
| 019872 | NDDF |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Flyrcado | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0407-8787 | INJECTION | 55 mCi | INTRAVENOUS | NDA | 25 sections |
| Flyrcado | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0407-8787 | INJECTION | 55 mCi | INTRAVENOUS | NDA | 25 sections |