FDA — authorised 22 May 2006
- Application: NDA021338
- Marketing authorisation holder: THE MEDICINES CO
- Local brand name: IONSYS
- Indication: SYSTEM — IONTOPHORESIS, TRANSDERMAL
- Status: approved
🇺🇸 i.v. fentanyl and AeroLEF in United States
FDA authorised i.v. fentanyl and AeroLEF on 22 May 2006
Marketing authorisation
i.v. fentanyl and AeroLEF 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 i.v. fentanyl and AeroLEF approved in United States?
Yes. FDA authorised it on 22 May 2006.
Who is the marketing authorisation holder for i.v. fentanyl and AeroLEF in United States?
THE MEDICINES CO holds the US marketing authorisation.