FDA — authorised 22 July 2014
- Application: NDA205437
- Marketing authorisation holder: AMGEN INC
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Otezla in United States
FDA authorised Otezla on 22 July 2014
Marketing authorisation
Otezla 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 Otezla approved in United States?
Yes. FDA authorised it on 22 July 2014.
Who is the marketing authorisation holder for Otezla in United States?
AMGEN INC holds the US marketing authorisation.