FDA — authorised 10 March 2021
- Application: BLA103846
- Marketing authorisation holder: ELAN PHARM
- Indication: Labeling
- Status: approved
🇺🇸 Myobloc in United States
FDA authorised Myobloc on 10 March 2021
Marketing authorisations
FDA
- Marketing authorisation holder: ELAN PHARM
- Status: approved
Myobloc 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 Myobloc approved in United States?
Yes. FDA authorised it on 10 March 2021; FDA has authorised it.
Who is the marketing authorisation holder for Myobloc in United States?
ELAN PHARM holds the US marketing authorisation.