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Drug ReportsBeractant
Beractant
Survanta (beractant) is an unknown pharmaceutical. Beractant was first approved as Survanta on 1991-07-01. 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
Survanta
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name
Status
Last Update
survantaBiologic Licensing Application2022-07-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
newborn respiratory distress syndromeD012127P22
Agency Specific
FDA
EMA
Expiration
Code
beractant, Survanta, AbbVie Inc.
2098-07-02Orphan excl.
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
17 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_1000637J801444312
Newborn respiratory distress syndromeD012127P221444312
SyndromeD013577132216
Premature birthD047928EFO_0003917O6011124
Bronchopulmonary dysplasiaD001997P27.811113
Respiratory insufficiencyD012131HP_0002093J96.9112
Lung diseasesD008171HP_0002088J98.411
Patent ductus arteriosusD004374HP_0001643Q25.011
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
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Total
Birth weightD001724EFO_0004344111
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hyaline membrane diseaseD006819EFO_1000644P22.011
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HemorrhageD006470MP_0001914R5811
Pulmonary hypertensionD006976EFO_0001361I27.2011
Respiratory tract diseasesD01214011
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBeractant
INN
Description
Beractant, also known by the trade name of Survanta, is a modified bovine pulmonary surfactant containing bovine lung extract (phospholipids, neutral lipids, fatty acids, and bovine surfactant proteins), to which synthetic DPPC, tripalmitin and palmitic acid are added. The composition provides 25 mg/mL phospholipids, 0.5 to 1.75 mg/mL triglycerides, 1.4 to 3.5 mg/mL free fatty acids, and <1.0 mg/mL total surfactant proteins. As an intratracheal suspension, it can be used for the prevention and treatment of neonatal respiratory distress syndrome. Survanta is manufactured by Abbvie.
Classification
Small molecule
Drug classpulmonary surfactants; tachykinin (neurokinin) receptor antagonists
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Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID108778-82-1
RxCUI46967
ChEMBL IDCHEMBL1201624
ChEBI ID
PubChem CID
DrugBankDB06761
UNII ID
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Additional graphs summarizing 783 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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361 adverse events reported
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