FDA — authorised 22 October 2012
- Application: NDA202834
- Marketing authorisation holder: CATALYST PHARMS
- Local brand name: FYCOMPA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Perampanel 1 week titration in United States
FDA authorised Perampanel 1 week titration on 22 October 2012
Marketing authorisations
FDA — authorised 29 April 2016
- Application: NDA208277
- Marketing authorisation holder: CATALYST PHARMS
- Local brand name: FYCOMPA
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Status: approved
Perampanel 1 week titration in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Perampanel 1 week titration 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 Perampanel 1 week titration in United States?
CATALYST PHARMS holds the US marketing authorisation.