| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5399 | 620-67-7 |
None
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 0.00 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 30, 2020 | FDA | ULTRAGENYX PHARM INC |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Rhabdomyolysis | 61.44 | 57.59 | 13 | 55 | 43938 | 63445016 |
None
None
None
| Source | Code | Description |
|---|---|---|
| ATC | A16AX17 | ALIMENTARY TRACT AND METABOLISM OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS Various alimentary tract and metabolism products |
| FDA CS | M0021969 | Triglycerides |
| FDA EPC | N0000194023 | Medium-chain Triglyceride |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Disorder of fatty acid metabolism | indication | 39929009 | |
| Long-chain fatty acid transport deficiency | indication | 426387005 |
None
None
None
None
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 100% w/w | DOJOLVI | ULTRAGENYX PHARM INC | N213687 | June 30, 2020 | RX | LIQUID | ORAL | June 30, 2025 | NEW CHEMICAL ENTITY |
| 100% w/w | DOJOLVI | ULTRAGENYX PHARM INC | N213687 | June 30, 2020 | RX | LIQUID | ORAL | June 30, 2027 | INDICATED AS A SOURCE OF CALORIES AND FATTY ACIDS FOR THE TREATMENT OF PEDIATRIC AND ADULT PATIENTS WITH MOLECULARLY CONFIRMED LONG-CHAIN FATTY ACID OXIDATION DISORDERS (LC-FAOD) |
None
| ID | Source |
|---|---|
| D11465 | KEGG_DRUG |
| 2P6O7CFW5K | UNII |
| C2604598 | UMLSCUI |
| CHEMBL4297585 | ChEMBL_ID |
| 69286 | PUBCHEM_CID |
| DB11677 | DRUGBANK_ID |
| 11431 | IUPHAR_LIGAND_ID |
| 018432 | NDDF |
| 926370002 | SNOMEDCT_US |
| 926378009 | SNOMEDCT_US |
| 4039553 | VANDF |
| 1313234 | RXNORM |
| 336029 | MMSL |
| 38592 | MMSL |
| d09588 | MMSL |
| C531010 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10893 | INN_ID |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| DOJOLVI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69794-050 | LIQUID | 0.96 g | ORAL | NDA | 25 sections |
| DOJOLVI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69794-050 | LIQUID | 0.96 g | ORAL | NDA | 25 sections |
| DOJOLVI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69794-050 | LIQUID | 0.96 g | ORAL | NDA | 25 sections |