🇺🇸 Adalimumab (Humira) in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised Adalimumab (Humira) on 31 December 2002

Marketing authorisation

FDA — authorised 31 December 2002

Application: BLA125057
Marketing authorisation holder: ABBVIE INC
Local brand name: HUMIRA
Indication: SYRINGE
Status: approved

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Other Immunology approved in United States

Frequently asked questions

Is Adalimumab (Humira) approved in United States?

Yes. FDA authorised it on 31 December 2002.

Who is the marketing authorisation holder for Adalimumab (Humira) in United States?

ABBVIE INC holds the US marketing authorisation.