FDA — authorised 25 October 2018
- Application: BLA206538
- Marketing authorisation holder: SANOFI US SERVICES
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Humulin in United States
FDA authorised Humulin on 25 October 2018
Marketing authorisations
FDA — authorised 20 December 2018
- Application: BLA021629
- Marketing authorisation holder: SANOFI AVENTIS US
- Indication: Labeling
- Status: approved
FDA — authorised 21 October 2019
- Application: BLA208751
- Marketing authorisation holder: NOVO
- Indication: Efficacy
- Status: approved
FDA — authorised 15 November 2019
- Application: BLA205692
- Marketing authorisation holder: ELI LILLY AND CO
- Indication: Labeling
- Status: approved
FDA — authorised 15 November 2019
- Application: BLA205747
- Marketing authorisation holder: ELI LILLY AND CO
- Indication: Labeling
- Status: approved
Humulin 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 Humulin approved in United States?
Yes. FDA authorised it on 25 October 2018; FDA authorised it on 20 December 2018; FDA authorised it on 21 October 2019.
Who is the marketing authorisation holder for Humulin in United States?
SANOFI US SERVICES holds the US marketing authorisation.