FDA — authorised 22 October 2012
- Application: NDA202834
- Marketing authorisation holder: CATALYST PHARMS
- Status: supplemented
🇺🇸 Fycompa in United States
FDA authorised Fycompa on 22 October 2012 · 2,968 US adverse-event reports
Marketing authorisations
FDA — authorised 29 April 2016
- Application: NDA208277
- Marketing authorisation holder: CATALYST PHARMS
- Status: supplemented
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 27 March 2025 – 27 March 2026
- Total reports: 2,968
Most-reported reactions
- Seizure — 700 reports (23.58%)
- Aggression — 356 reports (11.99%)
- Off Label Use — 343 reports (11.56%)
- Somnolence — 331 reports (11.15%)
- Drug Ineffective — 272 reports (9.16%)
- Dizziness — 268 reports (9.03%)
- Fatigue — 203 reports (6.84%)
- Epilepsy — 172 reports (5.8%)
- Irritability — 165 reports (5.56%)
- Suicidal Ideation — 158 reports (5.32%)
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 29 April 2016; FDA has authorised it.
Who is the marketing authorisation holder for Fycompa in United States?
CATALYST PHARMS holds the US marketing authorisation.