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Drug ReportsFosphenytoin
Fosphenytoin
Cerebyx, Fosphenytoin (fosphenytoin) is a small molecule pharmaceutical. Fosphenytoin was first approved as Cerebyx on 1996-08-05. It is used to treat epilepsy, seizures, and status epilepticus in the USA.
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Clinical
Drug
Target
Variants
Financial
Trends
Safety
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Cerebyx, Fosphenytoin (discontinued: Fosphenytoin, Sesquient)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fosphenytoin sodium
Tradename
Company
Number
Date
Products
CEREBYXPfizerN-020450 RX1996-08-05
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
cerebyxNew Drug Application2024-08-21
fosphenytoinANDA2023-03-31
fosphenytoin sodiumANDA2024-10-25
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
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FDA Information
Fosphenytoin Sodium, Sesquient, Lupin
94935822033-02-27DP
76357732029-03-13DP
84100772029-03-13DP
92000882029-03-13DP
97508222029-03-13DP
ATC Codes
N: Nervous system drugs
N03: Antiepileptics
N03A: Antiepileptics
N03AB: Hydantoin derivatives, antiepileptics
N03AB05: Fosphenytoin
HCPCS
Code
Description
Q2009
Injection, fosphenytoin, 50 mg phenytoin equivalent
S0078
Injection, fosphenytoin sodium, 750 mg
Clinical
Clinical Trials
14 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SeizuresD012640HP_0002069G40.41225
Status epilepticusD013226EFO_0008526G41213
Traumatic brain injuriesD000070642S06112
Brain injuriesD001930S06.9112
HemorrhageD006470MP_0001914R58112
Subarachnoid hemorrhageD013345EFO_0000713I60112
EmergenciesD00463011
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EpilepsyD004827EFO_0000474G40.922
Acute painD059787R5211
Herpes zosterD006562EFO_0006510B0211
Herpes simplexD006561B0011
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C95111
LymphomaD008223C85.9111
NeuroblastomaD009447EFO_0000621111
AnemiaD000740HP_0001903D64.9111
Immunologic deficiency syndromesD007153HP_0002721D84.9111
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GlioblastomaD005909EFO_000051511
GliomaD005910EFO_000052011
GliosarcomaD01831611
AstrocytomaD001254EFO_000027111
OligodendrogliomaD009837EFO_000063111
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Brain diseasesD001927HP_0001298G93.4011
NeuralgiaD009437EFO_000943011
Trigeminal neuralgiaD014277EFO_1001219G50.011
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFosphenytoin
INNfosphenytoin
Description
Fosphenytoin is an imidazolidine-2,4-dione.
Classification
Small molecule
Drug classphosphoro-derivatives; antiepileptics (hydantoin derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
O=C1NC(c2ccccc2)(c2ccccc2)C(=O)N1COP(=O)(O)O
Identifiers
PDB
CAS-ID93390-81-9
RxCUI
ChEMBL IDCHEMBL1201336
ChEBI ID5165
PubChem CID56339
DrugBankDB01320
UNII IDB4SF212641 (ChemIDplus, GSRS)
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 1,583 documents
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Safety
Black-box Warning
Black-box warning for: Cerebyx, Fosphenytoin
Adverse Events
Top Adverse Reactions
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1,702 adverse events reported
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