Stem definition | Drug id | CAS RN |
---|---|---|
systemic antifungal agents, miconazole derivatives | 5510 | 1340593-59-0 |
None
None
Date | Agency | Company | Orphan |
---|---|---|---|
April 26, 2022 | FDA | MYCOVIA PHARMACEUTICALS INC |
None
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 |
None
None
None
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 |