FDA — authorised 25 September 2015
- Application: BLA203314
- Marketing authorisation holder: NOVO
- Local brand name: TRESIBA
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
🇺🇸 Insulin Degludec U100 in United States
FDA authorised Insulin Degludec U100 on 25 September 2015
Marketing authorisations
FDA
- Status: approved
Insulin Degludec U100 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 Insulin Degludec U100 approved in United States?
Yes. FDA authorised it on 25 September 2015; FDA has authorised it.
Who is the marketing authorisation holder for Insulin Degludec U100 in United States?
NOVO holds the US marketing authorisation.