FDA — authorised 23 December 2019
- Marketing authorisation holder: ALLERGAN
- Status: approved
🇺🇸 Ubrelvy in United States
FDA authorised Ubrelvy on 23 December 2019
Marketing authorisations
FDA — authorised 3 March 2021
- Application: NDA211765
- Marketing authorisation holder: ABBVIE
- Indication: Labeling
- Status: approved
FDA
- Application: ANDA219088
- Marketing authorisation holder: AUROBINDO PHARMA LIMITED
- Local brand name: UBROGEPANT
- Indication: TABLET
- Status: approved
Ubrelvy 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 Ubrelvy approved in United States?
Yes. FDA authorised it on 23 December 2019; FDA authorised it on 3 March 2021; FDA has authorised it.
Who is the marketing authorisation holder for Ubrelvy in United States?
ALLERGAN holds the US marketing authorisation.