FDA — authorised 20 April 2004
- Application: NDA021264
- Marketing authorisation holder: MDD US
- Local brand name: APOKYN
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
🇺🇸 Safinamide (as add-on therapy) in United States
FDA authorised Safinamide (as add-on therapy) on 20 April 2004
Marketing authorisation
Other Neurology approved in United States
Frequently asked questions
Is Safinamide (as add-on therapy) approved in United States?
Yes. FDA authorised it on 20 April 2004.
Who is the marketing authorisation holder for Safinamide (as add-on therapy) in United States?
MDD US holds the US marketing authorisation.