FDA — authorised 21 November 2019
- Marketing authorisation holder: SK LIFE SCIENCE INC
- Status: approved
🇺🇸 Xcopri in United States
FDA authorised Xcopri on 21 November 2019
Marketing authorisations
FDA — authorised 21 November 2019
- Application: NDA212839
- Marketing authorisation holder: SK LIFE
- Local brand name: XCOPRI
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Xcopri, a medication developed by SK LIFE, for the treatment of epilepsy. This approval was granted on April 5, 2024, following a standard review process. Xcopri is the local brand name for the drug, and the marketing authorization holder is SK LIFE.
FDA
- Application: ANDA219403
- Marketing authorisation holder: ZENARA PHARMA PRIVATE LTD
- Local brand name: CENOBAMATE
- Indication: TABLET
- Status: approved
FDA
- Application: ANDA219473
- Marketing authorisation holder: AUROBINDO PHARMA LIMITED
- Local brand name: CENOBAMATE
- Indication: TABLET
- Status: approved
Xcopri in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Xcopri approved in United States?
Yes. FDA authorised it on 21 November 2019; FDA authorised it on 21 November 2019; FDA has authorised it.
Who is the marketing authorisation holder for Xcopri in United States?
SK LIFE SCIENCE INC holds the US marketing authorisation.