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Sold as Halaven. Every FDA application for this active ingredient: 1 branded and 11 generic.
As of Nov 15, 2026, FDA lists 12 applications for Eribulin Mesylate (sold as Halaven), first approved Nov 15, 2010, with 2 new uses approved and 0 published complete response letters.
First approved: Nov 15, 2010
Applications: 12
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $23.3M
First approved in the EU: Mar 17, 2011
First approved in Japan: Apr 22, 2011
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 5 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
HalavenA drug with a new additional indication for the treatment of soft tissue sarcoma. · Eisai Co., Ltd. · Feb 29, 2016 · Review report
Halaven, new ingredientA drug with a new active ingredient indicated for the treatment of inoperable or recurrent breast cancer. · Eisai Co., Ltd. · Apr 22, 2011 · Review report
Clinical Trials
81 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
Baxter Hlthcare Corp
Sandoz