FDA — authorised 16 April 2004
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: approved
🇺🇸 Apidra in United States
FDA authorised Apidra on 16 April 2004
Marketing authorisations
FDA — authorised 20 December 2018
- Application: BLA021629
- Marketing authorisation holder: SANOFI AVENTIS US
- Indication: Labeling
- Status: approved
Apidra 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 Apidra approved in United States?
Yes. FDA authorised it on 16 April 2004; FDA authorised it on 20 December 2018.
Who is the marketing authorisation holder for Apidra in United States?
SANOFI AVENTIS US holds the US marketing authorisation.