FDA — authorised 8 June 2017
- Application: BLA761032
- Marketing authorisation holder: VALEANT LUXEMBOURG
- Indication: REMS
- Status: approved
🇺🇸 Kyntheum in United States
FDA authorised Kyntheum on 8 June 2017
Marketing authorisation
Kyntheum in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Kyntheum approved in United States?
Yes. FDA authorised it on 8 June 2017.
Who is the marketing authorisation holder for Kyntheum in United States?
VALEANT LUXEMBOURG holds the US marketing authorisation.