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Carnexiv Approval History

  • FDA approved: Yes (First approved October 7th, 2016)
  • Brand name: Carnexiv
  • Generic name: carbamazepine
  • Dosage form: Injection
  • Company: Lundbeck Inc.
  • Treatment for: Seizures

Carnexiv (carbamazepine) is an intravenous injection formulation of the antiepileptic drug carbamazepine indicated as short-term replacement therapy for oral carbamazepine when oral administration is temporarily not feasible.

Carnexiv is administered via intravenous infusion over 30 minutes, every six hours. The total daily dosage of Carnexiv should be 70 percent of the total daily dose of oral carbamazepine, and patients should be switched back to their previous oral carbamazepine regimen as soon as clinically appropriate.

Common side effects include dizziness, somnolence, blurred vision, double vision, headache, infusion-related reactions, infusion site pain, and anemia.

Development History and FDA Approval Process for Carnexiv

DateArticle
Oct  7, 2016Approval FDA Approves Carnexiv (carbamazepine) injection as Intravenous Short-Term Replacement Therapy for Certain Seizure Types
Apr 22, 2016FDA Accepts Lundbeck Resubmission of New Drug Application for Carnexiv (carbamazepine)

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