NDAINJECTIONINJECTABLE
Approved
Aug 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
5/8 — Partial
CEREBYX (fosphenytoin sodium) by Pfizer is accordingly, its anticonvulsant effects are attributable to phenytoin. Approved for generalized tonic-clonic status epilepticus, prevention, treatment of seizures occurring during neurosurgery. First approved in 1996.
Drug data last refreshed 8h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CEREBYX (fosphenytoin sodium) is an intravenous anticonvulsant prodrug of phenytoin used to treat generalized tonic-clonic status epilepticus and prevent seizures during neurosurgery. It works by blocking voltage-dependent sodium channels in neuronal membranes, reducing sustained high-frequency neuronal discharges characteristic of seizure activity.
$0.051MPart D
LOE ApproachingDeclining
Declining commercial footprint with LOE approaching signals consolidation of brand team and shift toward maintenance mode or transition planning.
Mechanism of Action
accordingly, its anticonvulsant effects are attributable to phenytoin. The precise mechanism by which phenytoin exerts its therapeutic effect has not been established but is thought to involve the voltage-dependent blockade of membrane sodium channels resulting in a reduction in sustained…
Indications (3)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.