FDA — authorised 20 April 2000
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: approved
🇺🇸 Lantus in United States
FDA authorised Lantus on 20 April 2000
Marketing authorisations
FDA — authorised 5 September 2014
- Application: BLA021081
- Marketing authorisation holder: SANOFI AVENTIS US
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 25 October 2018
- Application: BLA206538
- Marketing authorisation holder: SANOFI US SERVICES
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 15 November 2019
- Application: BLA205692
- Marketing authorisation holder: ELI LILLY AND CO
- Indication: Labeling
- Status: approved
FDA — authorised 17 December 2021
- Application: BLA761215
- Marketing authorisation holder: ELI LILLY CO
- Indication: Type 2 - New Active Ingredient
- Status: approved
FDA — authorised 30 May 2023
- Application: BLA761201
- Marketing authorisation holder: MYLAN PHARMS INC
- Indication: Labeling
- Status: approved
Lantus 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 Lantus approved in United States?
Yes. FDA authorised it on 20 April 2000; FDA authorised it on 5 September 2014; FDA authorised it on 25 October 2018.
Who is the marketing authorisation holder for Lantus in United States?
SANOFI AVENTIS US holds the US marketing authorisation.