Dalvance, Xydalba(dalbavancin)
Dalvance, Xydalba (dalbavancin) is an unknown pharmaceutical. Dalbavancin was first approved as Dalvance on 2014-05-23. It is used to treat bacterial infections, infectious skin diseases, staphylococcal infections, and streptococcal infections in the USA. It has been approved in Europe to treat bacterial skin diseases and soft tissue infections.
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Commercial
Trade Name
FDA
EMA
Dalvance
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dalbavancin hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DALVANCE | Allergan | N-021883 RX | 2014-05-23 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dalvance | New Drug Application | 2018-10-05 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DALBAVANCIN HYDROCHLORIDE, DALVANCE, ALLERGAN | |||
| 2024-07-22 | NPP | ||
| 2024-05-23 | GAIN | ||
| 2019-05-23 | NCE | ||
HCPCS
Code | Description |
|---|---|
| J0875 | Injection, dalbavancin, 5 mg |
Clinical
Clinical Trials
28 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacterial infections | D001424 | A49 | 3 | — | 1 | 1 | 2 | 7 | |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | — | 2 | 1 | 1 | — | 4 |
| Gram-positive bacterial infections | D016908 | — | 1 | 1 | 1 | — | 2 | ||
| Infectious arthritis | D001170 | EFO_1001351 | M00 | — | — | — | 1 | — | 1 |
| Soft tissue infections | D018461 | — | — | — | 1 | — | 1 | ||
| Sinusitis | D012852 | EFO_0007486 | J32 | — | — | — | 1 | — | 1 |
| Feline infectious peritonitis | D016766 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | 4 | 1 | — | — | 4 |
| Wound infection | D014946 | — | — | 3 | — | — | 3 | ||
| Surgical wound infection | D013530 | — | — | 3 | — | — | 3 | ||
| Abscess | D000038 | EFO_0003030 | — | — | 3 | — | — | 3 | |
| Cellulitis | D002481 | EFO_0003035 | L03.90 | — | — | 3 | — | — | 3 |
| Methicillin-resistant staphylococcus aureus | D055624 | — | — | 1 | — | — | 1 | ||
| Staphylococcal skin infections | D013207 | EFO_1001849 | L00 | — | — | 1 | — | — | 1 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | 1 | — | — | 1 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | 1 | 1 | — | — | 1 |
| Intravenous substance abuse | D015819 | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endocarditis | D004696 | EFO_0000465 | I33 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Peritonitis | D010538 | EFO_0008588 | K65 | — | — | — | — | 1 | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | DALBAVANCIN |
| INN | dalbavancin |
| Description | Dalbavancin is a semisynthetic glycopeptide used for the treatment of acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of designated Gram-positive microorganisms including MRSA. It has a role as an antibacterial drug and an antimicrobial agent. It is a carbohydrate acid derivative, a monosaccharide derivative, a glycopeptide and a semisynthetic derivative. |
| Classification | Small molecule |
| Drug class | vancomycin-related compounds |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CN[C@H]1C(=O)N[C@@H]2Cc3ccc(cc3)Oc3cc4cc(c3O[C@@H]3O[C@H](C(=O)O)[C@@H](O)[C@H](O)[C@H]3NC(=O)CCCCCCCCC(C)C)Oc3ccc(cc3Cl)[C@@H](O)[C@@H]3NC(=O)[C@H](NC(=O)[C@@H]4NC(=O)[C@@H](NC2=O)c2cc(cc(O)c2Cl)Oc2cc1ccc2O)c1ccc(O)c(c1)-c1c(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@@H]2O)cc(O)cc1[C@@H](C(=O)NCCCN(C)C)NC3=O |
Identifiers
| PDB | — |
| CAS-ID | 171500-79-1 |
| RxCUI | 1539239 |
| ChEMBL ID | CHEMBL3301669 |
| ChEBI ID | 82721 |
| PubChem CID | 16134627 |
| DrugBank | DB06219 |
| UNII ID | 808UI9MS5K (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Dalvance - Allergan
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Dalvance - Warner Chilcott
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,490 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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71,656 adverse events reported
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