Quick answers
- What is Eribulin mesylate used for?
- The FDA-approved label (Halaven, Eisai Inc., November 7, 2025) says: “HALAVEN 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Eribulin mesylate have a boxed warning?
- No. None of the 16 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Eribulin mesylate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Eribulin mesylate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Eribulin mesylate?
- 16 companies list prescription products of Eribulin mesylate in the FDA NDC Directory, including Apotex Corp., Sandoz Inc and Hikma Pharmaceuticals USA Inc..
What Eribulin mesylate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
HALAVEN 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. …
— FDA label: Halaven, Eisai Inc., effective November 7, 2025. Read the full label on DailyMed →
The FDA has 16 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 16 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Solution |
|---|---|
| Route | Intravenous |
| Prescription products | 17 in the FDA NDC Directory |
| Brand names | Halaven |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Apotex Corp.2 products
- Sandoz Inc1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Sun Pharmaceutical Industries Limited1 product
- NorthStar Rx LLC1 product
- Dr.Reddys Laboratories Inc1 product
- Glenmark Pharmaceuticals Inc., USA1 product
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 product
- Long Grove Pharmaceuticals, LLC1 product
- Baxter Healthcare Company1 product
- BSP Pharmaceuticals SpA1 product
- BluePoint Laboratories1 product
- Gland Pharma Limited1 product
- XGen Pharmaceuticals DJB, Inc.1 product
- Kindos Pharmaceuticals Co., Ltd.1 product
- Eisai Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA201532 HALAVEN | Eisai Inc | November 15, 2010 | 16, latest September 13, 2022 2022: Efficacy · 2021: Labeling · 2021: Labeling |
Generic approvals (9)
- ANDA218047Gland · April 5, 2024
- ANDA218281Jiangxi Kvvit Pharm · June 28, 2024
- ANDA214850Long Grove Pharms · July 18, 2024
- ANDA217250Baxter Hlthcare Corp · October 1, 2024
- ANDA218743Chia Tai Tianqing · March 4, 2025
- ANDA214310Sandoz · June 9, 2025
- ANDA217473DR Reddys · July 3, 2025
- ANDA218142Glenmark Pharms · August 5, 2025
- ANDA219054Xgen Pharms · March 16, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1045456, 1045460 |
|---|---|
| SPL set ID of the quoted label | 31ce4750-ded5-4a0b-95e9-f229fa6bc822 |
| FDA labels (SPL) | 16 |
| FDA applications | NDA201532, 9 ANDA |
| Active ingredients (FDA) | ERIBULIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Halaven, Eisai Inc., effective November 7, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →