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Treats generalized tonic-clonic status epilepticus and prevention and treatment of…. Sold as Cerebyx, Sesquient. Every FDA application for this active ingredient: 2 branded and 14 generic.
As of Nov 15, 2026, FDA lists 16 applications for Fosphenytoin Sodium (sold as Cerebyx, Sesquient), first approved Aug 5, 1996, with 1 new use approved and 2 published complete response letters.
First approved: Aug 5, 1996
Applications: 16
New uses approved: 1
Complete response letters: 2
Medicare spending, 2025: $15K
First approved in Japan: Jul 1, 2011
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Cerebyx
Part D
$9K
-80%
0
Fosphenytoin Sodium
Part D
$6K
-48%
0
FDA Drug Safety Communications
One communication since 2020 that name this drug; see all communications
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Parke Davis
Hikma
Fresenius Kabi USA
Lupin