FDA — authorised 16 June 2005
- Application: BLA021536
- Marketing authorisation holder: NOVO NORDISK INC
- Local brand name: LEVEMIR FLEXPEN
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
🇺🇸 Levemir in United States
FDA authorised Levemir on 16 June 2005
Marketing authorisations
FDA — authorised 19 October 2005
- Application: BLA021878
- Marketing authorisation holder: NOVO NORDISK
- Local brand name: LEVEMIR
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Levemir 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 Levemir approved in United States?
Yes. FDA authorised it on 16 June 2005; FDA authorised it on 19 October 2005; FDA has authorised it.
Who is the marketing authorisation holder for Levemir in United States?
NOVO NORDISK INC holds the US marketing authorisation.