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 chronic severe. Sold as Inflectra, Zymfentra. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 2 applications for Infliximab-Dyyb (sold as Inflectra, Zymfentra), first approved Apr 5, 2016, with 1 new use approved and 0 published complete response letters.
First approved: Apr 5, 2016
Applications: 2
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $107M
First approved in the EU: Aug 13, 1999
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
RemicadeA drug with a new dosage indicated for the treatment of Crohn’s disease. · Mitsubishi Tanabe Pharma Corporation · May 18, 2017
RemicadeA drug with a new dosage indicated for plaque psoriasis, psoriatic arthritis, pustular psoriasis, and erythrodermic psoriasis in patients who have not… · Mitsubishi Tanabe Pharma Corporation · May 13, 2016
RemicadeA drug with a new additional indication and a new dosage for the treatment of acute-phase Kawasaki's disease in patients who have not responded sufficiently… · Mitsubishi Tanabe Pharma Corporation · Dec 21, 2015
RemicadeA drug with new additional indications and a new dosage for the treatment of entero-Behcet's disease, neuro-Behcet's disease, and vasculo- Behcet's disease… · Mitsubishi Tanabe Pharma Corporation · Aug 24, 2015 · Review report
RemicadeA drug with a new dosage indicated for the treatment of Crohn's disease. · Mitsubishi Tanabe Pharma Corporation · Aug 17, 2011
RemicadeA drug with a new additional indication and a new dosage for the treatment of moderate to severe ulcerative colitis (for use only in patients who have not… · Mitsubishi Tanabe Pharma Corporation · Jun 18, 2010
RemicadeA drug with a new additional indication and a new dosage for the treatment of ankylosing spondylitis in patients who have not responded sufficiently to… · Mitsubishi Tanabe Pharma Corporation · Apr 16, 2010
RemicadeA drug with new additional indications and a new dosage for the treatment of plaque psoriasis, psoriatic arthritis, pustular psoriasis, and erythrodermic… · Mitsubishi Tanabe Pharma Corporation · Jan 20, 2010
Clinical Trials
2 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
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
