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Sesquient FDA Approval History

FDA Approved: Yes (First approved November 5, 2020)
Brand name: Sesquient
Generic name: fosphenytoin sodium
Dosage form: for Injection
Company: Sedor Pharmaceuticals, LLC
Treatment for: Status Epilepticus

Sesquient (fosphenytoin sodium for injection) is a Captisol-enabledâ„¢, room-temperature stable formulation of fosphenytoin sodium indicated for the treatment of status epilepticus in adults and children.

  • Sesquient is ready-to-dilute and allows for point-of-care storage, making it fast and efficient to administer in emergency settings.
  • Sesquient is indicated for the treatment of generalized tonic-clonic status epilepticus in adult patients; for the prevention and treatment of seizures occurring during neurosurgery in adult patients; and for short-term substitution for oral phenytoin in patients 2 years of age and older. Sesquient should be used only when oral phenytoin administration is not possible.
  • The Sesquient product label carries a boxed warning that advises the risk of adverse cardiovascular reactions (including severe hypotension and cardiac arrhythmias) associated with rapid intravenous administration. Careful cardiac monitoring is required during and after treatment with Sesquient.
  • Common adverse reactions in adults include pruritus, nystagmus, dizziness, somnolence, and ataxia. Common adverse reactions in children include vomiting, nystagmus, and ataxia.

Development Timeline for Sesquient

DateArticle
Nov  9, 2020Approval FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients
May 30, 2018Sedor Pharmaceuticals Files NDA for CE-Fosphenytoin for Status Epilepticus

Further information

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