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Drug ReportsCalfactant
Calfactant
Infasurf (calfactant) is an unknown pharmaceutical. Calfactant was first approved as Infasurf on 1998-07-01. It is used to treat newborn respiratory distress syndrome in the USA.
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FDA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
Infasurf
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name
Status
Last Update
infasurfBiologic Licensing Application2023-09-26
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
newborn respiratory distress syndrome—D012127P22
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
20 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Respiratory distress syndromeD012128EFO_1000637J80—141511
Newborn respiratory distress syndromeD012127—P22—141511
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bronchopulmonary dysplasiaD001997—P27.8122—15
SyndromeD013577———11—13
Acute lung injuryD055371EFO_0004610——12——2
HyperplasiaD006965EFO_0000536———1——1
Lung injuryD055370—S27.30—11——1
Premature birthD047928EFO_0003917O60——1——1
Lung transplantationD016040———11——1
Primary graft dysfunctionD055031———11——1
Perinatal deathD066087HP_0003811———1——1
Intratracheal intubationD007442————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung diseasesD008171HP_0002088J98.4—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
BronchiolitisD001988HP_0011950—1————1
Connective tissue diseasesD003240EFO_1001986M351————1
Skin and connective tissue diseasesD017437——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FibrosisD005355——————11
Cystic fibrosisD003550EFO_0000390E84————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCalfactant
INN—
Description
Calfactant, also known as Infasurf, is an intratracheal suspension derived from the natural surfactant in calf lungs. It is used in premature infants with lung surfactant deficiency that causes infant respiratory distress syndrome (IRDS).
Classification
Small molecule
Drug classpulmonary surfactants; tachykinin (neurokinin) receptor antagonists
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID183325-78-2
RxCUI232539
ChEMBL IDCHEMBL1201447
ChEBI ID—
PubChem CID—
DrugBankDB06415
UNII ID—
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 523 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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103 adverse events reported
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