FDA — authorised 14 June 1996
- Marketing authorisation holder: LILLY
- Status: approved
🇺🇸 Humalog in United States
FDA authorised Humalog on 14 June 1996
Marketing authorisations
FDA — authorised 14 June 1996
- Application: BLA020563
- Marketing authorisation holder: LILLY
- Local brand name: HUMALOG
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 December 2017
- Application: BLA209196
- Marketing authorisation holder: SANOFI-AVENTIS US
- Local brand name: ADMELOG SOLOSTAR
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
Humalog 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 Humalog approved in United States?
Yes. FDA authorised it on 14 June 1996; FDA authorised it on 14 June 1996; FDA authorised it on 11 December 2017.
Who is the marketing authorisation holder for Humalog in United States?
LILLY holds the US marketing authorisation.