FDA — authorised 24 August 2011
- Application: BLA103000
- Marketing authorisation holder: ALLERGAN
- Indication: Efficacy
- Status: approved
🇺🇸 Botox in United States
FDA authorised Botox on 24 August 2011
Marketing authorisations
FDA
- Marketing authorisation holder: ALLERGAN
- Status: approved
Botox 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 Botox approved in United States?
Yes. FDA authorised it on 24 August 2011; FDA has authorised it.
Who is the marketing authorisation holder for Botox in United States?
ALLERGAN holds the US marketing authorisation.