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.
Sold as Entyvio. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 3 applications for Vedolizumab (sold as Entyvio), first approved May 20, 2014, with 1 new use approved and 1 published complete response letter.
First approved: May 20, 2014
Applications: 3
New uses approved: 1
Complete response letters: 1
Medicare spending, 2025: $1.04B
First approved in the EU: May 22, 2014
First approved in Japan: Jul 2, 2018
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 49 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Entyvio PensDrugs with a new indication for the maintenance therapy of moderate to severe active Crohn’s disease (for use only in patients who have not sufficiently… · Takeda Pharmaceutical Company Limited · Sep 25, 2023
Entyvio Pens, new approvalDrugs with a new route of administration indicated for the maintenance therapy of moderate to severe ulcerative colitis (for use only in patients who have… · Takeda Pharmaceutical Company Limited · Mar 27, 2023
EntyvioA drug with a new additional indication for the treatment and maintenance therapy of moderate to severe active Crohn's disease (for use only in patients who… · Takeda Pharmaceutical Company Limited · May 22, 2019
Entyvio, new ingredientA drug with a new active ingredient indicated for the treatment and maintenance therapy of moderate to severe ulcerative colitis (for use only in patients… · Takeda Pharmaceutical Company Limited · Jul 2, 2018
Clinical Trials
63 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
MLNO0002 SCProduct Quality, Human Factors, Non-Proprietary Name
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
