Prescription medicine
Eribulin Brand names: Halaven
Eribulin (Halaven) is a prescription medicine with an FDA approval on record since 2010. FDA's NDC Directory lists it from 14 generic labelers.
- Generic listed
Check it at the source: the eribulin FDA label on DailyMed (effective November 7, 2025, Eisai Inc.); the NDA 201532 record on Drugs@FDA; every eribulin label on DailyMed.
Highlights of the record
FDA label of November 7, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageHALAVEN is a microtubule inhibitor indicated for the treatment of patients with: Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.
Forms and strengths
- 0.5 mg/ml
- 1 mg/2ml
Injection; solution.
On the market
- Earliest approval on file
- November 15, 2010 Halaven, Eisai Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first April 5, 2024; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 16 of which 14 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- July 8, 2027 Halaven injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,719 through July 30, 2026
What is eribulin used for?
From the label: indications and usageHALAVEN is a microtubule inhibitor indicated for the treatment of patients with: Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. ( 1.1 ) Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. ( 1.2 ) 1.1 Me tastatic Breast Cancer HALAVEN is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. […]
Conditions named in the indications of eribulin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Microtubule Inhibitor.
Source: FDA drug label (Halaven), Eisai Inc., effective November 7, 2025 (SPL set 31ce4750-ded5-4a0b-95e9-f229fa6bc822), via openFDA; the full label on DailyMed
What does the patient leaflet for eribulin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about HALAVEN?HALAVEN can cause serious side effects, including: Low white blood cell count (neutropenia). This can lead to serious infections that could lead to death. Your healthcare provider will check your blood cell counts before you receive each dose of HALAVEN and during treatment. Call your healthcare provider right away if you develop any of these symptoms of infection: ° fever (temperature above 100.5°F) ° chills ° cough ° burning or pain when you urinate N umbness, tingling, or pain in your hands or feet ( peripheral neuropathy). Peripheral neuropathy is common with HALAVEN and sometimes can be severe. Tell your healthcare provider if you have new or worsening symptoms of peripheral neuropathy. Your healthcare provider may delay, decrease your dose, or stop treatment with HALAVEN if you have side effects. See “ What are possible side effects of HALAVEN?” for more information about side effects.
Source: FDA drug label (Halaven), Eisai Inc., effective November 7, 2025 (SPL set 31ce4750-ded5-4a0b-95e9-f229fa6bc822), via openFDA; the full label on DailyMed
Is there a generic for eribulin (Halaven)?
The FDA approved the first generic eribulin on April 5, 2024. 10 generic applications are approved; 10 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists eribulin from 14 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Halaven injection, the last expiring on July 8, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2010 earliest approval on file
- 2024 first generic approved
- 2027 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the eribulin label say about other medicines?
The eribulin label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Ketoconazole | drug interactions | Clinically meaningful differences in exposure (AUC) were not observed in patients with advanced solid tumors when HALAVEN was administered with or without ketoconazole (a strong inhibitor of CYP3A4 and a P-gp inhibitor) and when HALAVEN was administered with or without rifampin (a CYP3A4 inducer) [see Clinical … |
| Rifampin | drug interactions | Clinically meaningful differences in exposure (AUC) were not observed in patients with advanced solid tumors when HALAVEN was administered with or without ketoconazole (a strong inhibitor of CYP3A4 and a P-gp inhibitor) and when HALAVEN was administered with or without rifampin (a CYP3A4 inducer) [see Clinical … |
Source: FDA drug label (Halaven), Eisai Inc., effective November 7, 2025 (SPL set 31ce4750-ded5-4a0b-95e9-f229fa6bc822), via openFDA; the full label on DailyMed
What do FAERS reports show for eribulin?
The FDA Adverse Event Reporting System holds 3,719 reports that list eribulin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 659 are coded as a death and 1,947 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as eribulin?
12 other medicines are given the same way (intravenous) and in the same FDA class as eribulin or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Docetaxel | Breast cancer | 14 labelers | n/a | A presentation being discontinued |
| Paclitaxel | Breast cancer | 20 labelers | n/a | No current entry |
| Gemcitabine | Breast cancer | 10 labelers | n/a | No current entry |
| Trastuzumab | Breast cancer | none listed | n/a | No current entry |
| Margetuximab | Breast cancer | none listed | n/a | No current entry |
| Trastuzumab emtansine | Breast cancer | none listed | n/a | No current entry |
| Trastuzumab-strf | Breast cancer | none listed | n/a | No current entry |
| Fulvestrant | Breast cancer | 1 labeler | n/a | A presentation being discontinued |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to eribulin
- 12 medicines for the same use
- Other microtubule inhibitors
- the pharmacologic class, with prices and generics
- Eribulin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other