FDA — authorised 22 October 2012
- Application: NDA202834
- Marketing authorisation holder: CATALYST PHARMS
- Local brand name: FYCOMPA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Fycompa in United States
FDA authorised Fycompa on 22 October 2012
Marketing authorisations
FDA — authorised 22 October 2012
- Marketing authorisation holder: EISAI INC
- Status: approved
FDA — authorised 29 April 2016
- Application: NDA208277
- Marketing authorisation holder: CATALYST PHARMS
- Local brand name: FYCOMPA
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 23 May 2025
- Application: ANDA209801
- Marketing authorisation holder: TEVA PHARMS USA INC
- Status: approved
FDA — authorised 11 July 2025
- Application: ANDA218152
- Marketing authorisation holder: MSN
- Status: approved
FDA — authorised 25 November 2025
- Application: ANDA218178
- Marketing authorisation holder: MSN
- Status: approved
FDA — authorised 25 November 2025
- Application: ANDA209538
- Marketing authorisation holder: TARO
- Status: approved
Fycompa 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 Fycompa approved in United States?
Yes. FDA authorised it on 22 October 2012; FDA authorised it on 22 October 2012; FDA authorised it on 29 April 2016.
Who is the marketing authorisation holder for Fycompa in United States?
CATALYST PHARMS holds the US marketing authorisation.