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 22h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CEREBYX (fosphenytoin sodium) is an injectable anticonvulsant prodrug that is rapidly converted to phenytoin in the body. It is indicated for acute seizure management, including generalized tonic-clonic status epilepticus, seizure prevention, and treatment of seizures during neurosurgery. The drug works by blocking voltage-dependent sodium channels to reduce sustained high-frequency neuronal discharges.
$0.051BPart D
LOE ApproachingDeclining
Small Part D footprint and LOE-approaching status indicate a contracted team focused on defending market share against generics rather than growth initiatives.
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.