🇺🇸 Apidra in United States

FDA authorised Apidra on 16 April 2004

Marketing authorisations

FDA — authorised 16 April 2004

  • Application: BLA021629
  • Marketing authorisation holder: SANOFI AVENTIS US
  • Status: supplemented

FDA

  • 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 has authorised it.

Who is the marketing authorisation holder for Apidra in United States?

SANOFI AVENTIS US holds the US marketing authorisation.