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 relapsing forms of multiple sclerosis. Sold as Tysabri. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Natalizumab (sold as Tysabri), first approved Nov 23, 2004, with 5 new uses approved and 0 published complete response letters.
First approved: Nov 23, 2004
Applications: 1
New uses approved: 5
Complete response letters: 0
Medicare spending, 2025: $204M
First approved in the EU: Jun 27, 2006
First approved in Japan: Mar 24, 2014
Safety program: REMS
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 112 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Tysabri, new ingredientA drug with a new active ingredient indicated for the prevention of relapse and for delaying the accumulation of physical disability in multiple sclerosis. · Biogen Idec Japan Ltd. · Mar 24, 2014
Safety Programs (REMS)
FDA requires these when a drug's risks need more than a label: training, enrollment or extra checks before it is prescribed or dispensed
Program
Updated
Tysabri REMSRestricted: prescribers, pharmacies or patients must be certified or enrolled · Medication Guide for patients
Mar 27, 2025
Clinical Trials
11 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
