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Xcopri FDA Approval History

Last updated by Judith Stewart, BPharm on April 14, 2024.

FDA Approved: Yes (First approved November 21, 2019)
Brand name: Xcopri
Generic name: cenobamate
Dosage form: Tablets
Company: SK Life Science, Inc.
Treatment for: Seizures

Xcopri (cenobamate) is an antiepileptic drug for the treatment of partial-onset seizures in adult patients.

Development timeline for Xcopri

Apr 11, 2024Approval Xcopri (cenobamate) Receives FDA Approval for Alternate Methods of Administration That Include Crushed Tablet in Liquid Suspension Taken Orally or Through a Nasogastric Tube
Nov 21, 2019Approval FDA Approves Xcopri (cenobamate) for the Treatment of Partial-Onset Seizures in Adults
Nov 13, 2019Results of a Randomized Study of the Safety and Efficacy of Cenobamate in Adults with Uncontrolled Focal Seizures Published in The Lancet Neurology
Feb  4, 2019SK Life Science Announces FDA Acceptance of NDA Submission for Cenobamate, an Investigational Antiepileptic Drug

Further information

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