| Stem definition | Drug id | CAS RN |
|---|---|---|
| systemic antifungal agents, miconazole derivatives | 5510 | 1340593-59-0 |
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 26, 2022 | FDA | MYCOVIA PHARMACEUTICALS INC |
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None
None
None
| Source | Code | Description |
|---|---|---|
| ATC | J02AC06 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOTICS FOR SYSTEMIC USE ANTIMYCOTICS FOR SYSTEMIC USE Triazole and tetrazole derivatives |
| FDA CS | M0002083 | Azoles |
| FDA EPC | N0000175487 | Azole Antifungal |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Recurrent vulvovaginal candidiasis (RVVC) | indication | 708126004 | |
| Lactation | contraindication | 63158009 | |
| Pregnancy, function | contraindication | 289908002 |
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| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 150MG | VIVJOA | MYCOVIA PHARMS | N215888 | April 26, 2022 | RX | CAPSULE | ORAL | 8754227 | April 22, 2031 | VIVJOA IS INDICATED TO REDUCE THE INCIDENCE OF RECURRENT VULVOVAGINAL CANDIDIASIS (RVVC) IN FEMALES WITH A HISTORY OF RVVC WHO ARE NOT OF REPRODUCTIVE POTENTIAL |
| 150MG | VIVJOA | MYCOVIA PHARMS | N215888 | April 26, 2022 | RX | CAPSULE | ORAL | 11247981 | May 9, 2033 | VIVJOA IS INDICATED TO REDUCE THE INCIDENCE OF RECURRENT VULVOVAGINAL CANDIDIASIS (RVVC) IN FEMALES WITH A HISTORY OF RVVC WHO ARE NOT OF REPRODUCTIVE POTENTIAL |
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 150MG | VIVJOA | MYCOVIA PHARMS | N215888 | April 26, 2022 | RX | CAPSULE | ORAL | April 26, 2027 | NEW CHEMICAL ENTITY |
| 150MG | VIVJOA | MYCOVIA PHARMS | N215888 | April 26, 2022 | RX | CAPSULE | ORAL | April 26, 2032 | GENERATING ANTIBIOTIC INCENTIVES NOW |
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Cytochrome P450 3A4 | Enzyme | INHIBITOR | IC50 | 4.19 | SCIENTIFIC LITERATURE | ||||
| Cytochrome P450 2C9 | Enzyme | INHIBITOR | IC50 | 4 | SCIENTIFIC LITERATURE | ||||
| Cytochrome P450 2C19 | Enzyme | INHIBITOR | IC50 | 4.14 | SCIENTIFIC LITERATURE | ||||
| Lanosterol 14-alpha demethylase | Enzyme | INHIBITOR | Kd | 7.41 | SCIENTIFIC LITERATURE | DRUG LABEL |
| ID | Source |
|---|---|
| CHEBI:188153 | CHEBI |
| VT1 | PDB_CHEM_ID |
| CHEMBL3311228 | ChEMBL_ID |
| C000599187 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB13055 | DRUGBANK_ID |
| 019048 | NDDF |
| 4041587 | VANDF |
| C4519300 | UMLSCUI |
| D11785 | KEGG_DRUG |
| 10138 | INN_ID |
| 77050711 | PUBCHEM_CID |
| 2602577 | RXNORM |
| 40649 | MMSL |
| d09883 | MMSL |
| VHH774W97N | UNII |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| VIVJOA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 74695-823 | CAPSULE | 150 mg | ORAL | NDA | 32 sections |