FDA — authorised 24 August 2017
- Application: NDA208944
- Marketing authorisation holder: SUPERNUS PHARMS
- Local brand name: GOCOVRI
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Gocovri in United States
FDA authorised Gocovri on 24 August 2017
Marketing authorisations
FDA — authorised 26 August 2024
- Application: ANDA214897
- Marketing authorisation holder: ZYDUS
- Local brand name: AMANTADINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
Gocovri in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Gocovri approved in United States?
Yes. FDA authorised it on 24 August 2017; FDA authorised it on 26 August 2024; FDA has authorised it.
Who is the marketing authorisation holder for Gocovri in United States?
SUPERNUS PHARMS holds the US marketing authorisation.