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Fosphenytoin
Cerebyx (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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Cerebyx (generic drugs available since 2007-08-06, discontinued: 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 Application2022-05-10
fosphenytoinANDA2023-03-31
sesquientNew Drug Application2020-11-13
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
epilepsyEFO_0000474D004827G40.9
seizuresHP_0007359D012640G40.4
status epilepticusEFO_0008526D013226G41
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
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
8 clinical trials
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Mock data
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
VomitingD014839HP_0002013R11.1—14——4
Drug-related side effects and adverse reactionsD064420T88.7—11——1
Uterine cervical neoplasmsD002583—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gallbladder neoplasmsD005706EFO_0004606C23—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—1————1
Indications Without Phase
No data
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)
Structure (InChI/SMILES or Protein Sequence)
O=C1NC(c2ccccc2)(c2ccccc2)C(=O)N1COP(=O)(O)O
Identifiers
PDB—
CAS-ID93390-81-9
RxCUI72236
ChEMBL IDCHEMBL1201336
ChEBI ID5165
PubChem CID56339
DrugBankDB01320
UNII IDB4SF212641 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 1,325 documents
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Safety
Black-box Warning
Black-box warning for: Cerebyx, Fosphenytoin, Sesquient
Adverse Events
Top Adverse Reactions
Mock data
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298 adverse events reported
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