FDA — authorised 22 May 2006
- Application: NDA021338
- Marketing authorisation holder: THE MEDICINES CO
- Local brand name: IONSYS
- Indication: SYSTEM — IONTOPHORESIS, TRANSDERMAL
- Status: approved
🇺🇸 Fentanyl ITS in United States
FDA authorised Fentanyl ITS on 22 May 2006
Marketing authorisations
FDA
- Status: approved
Fentanyl ITS in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Fentanyl ITS approved in United States?
Yes. FDA authorised it on 22 May 2006; FDA has authorised it.
Who is the marketing authorisation holder for Fentanyl ITS in United States?
THE MEDICINES CO holds the US marketing authorisation.