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 Gadavist. Every FDA application for this active ingredient: 1 branded and 6 generic.
As of Nov 15, 2026, FDA lists 7 applications for Gadobutrol (sold as Gadavist), first approved Mar 14, 2011, with 4 new uses approved and 0 published complete response letters.
First approved: Mar 14, 2011
Applications: 7
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $6.1M
First approved in Japan: Mar 26, 2015
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Product
Part
Spending, 2025
Change
Beneficiaries
Gadavist
Part B
$6.1M
-9%
236,774
Approvals in Japan (PMDA)
First approved in Japan 48 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Gadovist IV, new ingredientDrugs with a new active ingredient indicated for visibility of brain/spinal cord and trunk/extremities in magnetic resonance computer tomographic imaging as… · Bayer Yakuhin, Ltd. · Mar 26, 2015
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
Bayer Hlthcare