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 • Unresectable hepatocellular carcinoma. Sold as Nexavar. Every FDA application for this active ingredient: 1 branded and 6 generic.
As of Nov 15, 2026, FDA lists 7 applications for Sorafenib Tosylate (sold as Nexavar), first approved Dec 1, 2005, with 6 new uses approved and 0 published complete response letters.
First approved: Dec 1, 2005
Applications: 7
New uses approved: 6
Complete response letters: 0
Medicare spending, 2025: $19.5M
First approved in the EU: Jul 19, 2006
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
NexavarA drug with a revised indication for the treatment of unresectable thyroid cancer. · Bayer Yakuhin, Ltd. · Feb 29, 2016
NexavarA drug with a new additional indication for the treatment of unresectable differentiated thyroid carcinoma. · Bayer Yakuhin, Ltd. · Jun 20, 2014
NexavarA drug with a new additional indication for the treatment of unresectable hepatocellular carcinoma. · Bayer Yakuhin, Ltd. · May 20, 2009
Clinical Trials
6 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
Bayer Hlthcare
Mylan
Apotex