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 Erbitux. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Cetuximab (sold as Erbitux), first approved Feb 12, 2004, with 8 new uses approved and 0 published complete response letters.
First approved: Feb 12, 2004
Applications: 1
New uses approved: 8
Complete response letters: 0
Medicare spending, 2025: $192M
First approved in the EU: Jun 29, 2004
First approved in Japan: Jul 16, 2008
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 53 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
ErbituxA drug with a new additional dosage indicated for the treatment of unresectable, advanced or recurrent colon or rectal cancer with wild-type RAS and head… · Merck Biopharma Co., Ltd. · Sep 26, 2022
ErbituxA drug with a new indication for the treatment of unresectable, advanced or recurrent colon or rectal cancer with wild-type RAS . · Merck Biopharma Co., Ltd. · Sep 20, 2019
ErbituxA drug with a new additional indication for the treatment of head and neck cancer. · Merck Serono Co., Ltd. · Dec 21, 2012
Erbitux, new ingredientA drug containing a new active ingredient indicated for the treatment of EGFR-expressing, unresectable and advanced/recurrent colorectal carcinomas. · Merck KGaA · Jul 16, 2008
Clinical Trials
292 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
