FDA — authorised 21 February 2020
- Application: BLA761119
- Marketing authorisation holder: Lundbeck Seattle BioPharmaceuticals, Inc.
- Local brand name: VYEPTI
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 ALD403 in United States
FDA authorised ALD403 on 21 February 2020
Marketing authorisation
Other Neurology approved in United States
Frequently asked questions
Is ALD403 approved in United States?
Yes. FDA authorised it on 21 February 2020.
Who is the marketing authorisation holder for ALD403 in United States?
Lundbeck Seattle BioPharmaceuticals, Inc. holds the US marketing authorisation.