FDA — authorised 7 May 2001
- Application: NDA021001
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: AXERT
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Axert in United States
FDA authorised Axert on 7 May 2001
Marketing authorisations
FDA
- Status: approved
Axert 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 Axert approved in United States?
Yes. FDA authorised it on 7 May 2001; FDA has authorised it.
Who is the marketing authorisation holder for Axert in United States?
JANSSEN PHARMS holds the US marketing authorisation.