FDA — authorised 25 September 2015
- Marketing authorisation holder: NOVO NORDISK INC
- Status: approved
🇺🇸 Tresiba in United States
FDA authorised Tresiba on 25 September 2015
Marketing authorisations
FDA — authorised 25 September 2015
- Application: BLA203314
- Marketing authorisation holder: NOVO
- Local brand name: TRESIBA
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
Tresiba in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Tresiba approved in United States?
Yes. FDA authorised it on 25 September 2015; FDA authorised it on 25 September 2015.
Who is the marketing authorisation holder for Tresiba in United States?
NOVO NORDISK INC holds the US marketing authorisation.