Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats moderately to severely active Crohn's disease. Sold as Yuflyma. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Adalimumab-Aaty (sold as Yuflyma), first approved May 23, 2023, with 0 new uses approved and 2 published complete response letters.
First approved: May 23, 2023
Applications: 1
New uses approved: 0
Complete response letters: 2
Medicare spending, 2025: $111M
Orphan exclusivity until: Feb 24, 2028
First approved in the EU: Sep 1, 2003
First approved in Japan: Apr 16, 2008
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 181 months before the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
HumiraDrugs with a new indication and a new dosage for the treatment of non-radiographic axial spondyloarthritis in patients who have not responded sufficiently… · AbbVie GK · Feb 20, 2025
HumiraDrugs with a new indication and a new dosage, including a new additional pediatric dosage, for the treatment of moderate or severe ulcerative colitis (for… · AbbVie GK · Sep 27, 2021
HumiraDrugs with a new indication and a new dosage for the treatment of pyoderma gangrenosum. · AbbVie GK · Nov 27, 2020
HumiraDrugs with a new dosage indicated for the treatment of hidradenitis suppurativa. · AbbVie GK · May 29, 2020
HumiraDrugs with a new additional indication and a new dosage for the treatment of hidradenitis suppurativa. · AbbVie GK · Feb 21, 2019
HumiraDrugs with a new additional indication and a new dosage indicated for the treatment of pustular psoriasis in patients who have not responded sufficiently to… · AbbVie GK · Mar 23, 2018
HumiraDrugs with a new additional indication and a new dosage for the treatment of non-infectious intermediate, posterior, and panuveitis in patients who have not… · AbbVie GK · Sep 28, 2016 · Review report
HumiraA drug with a new dosage indicated for the treatment of Crohn's disease. · AbbVie GK · Jun 20, 2016
Clinical Trials
1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all
CT-P17Facility Inspections Deficiencies, Product Quality, Center For Devices And Radiological Health
Approved
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
