Quick answers
- What is Fulvestrant used for?
- The FDA-approved label (Faslodex, AstraZeneca Pharmaceuticals LP, September 25, 2020) says: “Monotherapy FASLODEX is indicated for the treatment of: • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fulvestrant have a boxed warning?
- No. None of the 21 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Fulvestrant?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated August 14, 2026). Ask your pharmacist about alternatives.
- Has Fulvestrant been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started July 15, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Fulvestrant?
- 21 companies list prescription products of Fulvestrant in the FDA NDC Directory, including Sandoz Inc, Sagent Pharmaceuticals and BluePoint Laboratories.
What Fulvestrant is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Monotherapy FASLODEX is indicated for the treatment of: • Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or • HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. …
— FDA label: Faslodex, AstraZeneca Pharmaceuticals LP, effective September 25, 2020. Read the full label on DailyMed →
The FDA has 21 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 21 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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.
- Sandoz Inc2 products
- Sagent Pharmaceuticals2 products
- BluePoint Laboratories2 products
- Amneal Pharmaceuticals LLC2 products
- Avyxa Pharma, LLC1 product
- Accord Healthcare Inc.1 product
- Dr. Reddy's Laboratories Inc.1 product
- Glenmark Pharmaceuticals Inc., USA1 product
- Xiromed, LLC1 product
- NorthStar Rx LLC1 product
- Alembic Pharmaceuticals Inc.1 product
- Hikma Pharmaceuticals USA Inc.1 product
- AstraZeneca Pharmaceuticals LP1 product
- Athenex Pharmaceutical Division, LLC.1 product
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 product
- Fresenius Kabi USA, LLC1 product
- Avenacy Inc.1 product
- Eugia US LLC1 product
- Zydus Pharmaceuticals USA Inc.1 product
- Zydus Lifesciences Limited1 product
- Meitheal Pharmaceuticals 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 |
|---|---|---|---|
| NDA021344 FASLODEX | Astrazeneca | April 25, 2002 | 30, latest January 19, 2021 2021: Labeling · 2020: Efficacy · 2020: Efficacy |
| NDA210063 CLIGAVYX | Avyxa Holdings | August 19, 2019 | 3, latest November 21, 2025 2025: Labeling · 2021: Labeling · 2021: Labeling |
| NDA210326 FULVESTRANT | Fresenius Kabi USA | May 20, 2019 | 2, latest May 12, 2021 2021: Labeling · 2021: Efficacy |
Generic approvals (12)
- ANDA210044Amneal · March 4, 2019
- ANDA205935Sandoz · May 14, 2019
- ANDA207754Glenmark Pharms · August 22, 2019
- ANDA209714Hbt Labs Inc · November 21, 2019
- ANDA211422Chia Tai Tianqing · February 7, 2020
- ANDA209246DR Reddys · August 7, 2020
- ANDA211689Accord Hlthcare · November 17, 2020
- ANDA215234Zydus Pharms · July 29, 2021
- ANDA213553Xiromed · August 13, 2021
- ANDA214682Jiangsu Hansoh Pharm · February 10, 2022
- ANDA215077Alembic · December 22, 2022
- ANDA215169Eugia Pharma · June 30, 2023
Shortage status
To be discontinued · updated August 14, 2026 · first posted August 14, 2026
| Product | Fulvestrant, Injection, 250 mg per 5mL (NDC 63323-715-05) |
|---|---|
| Company | Fresenius Kabi USA, LLC |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 15, 2022 · Class II · Terminated · D-1351-2022
Failed Impurities/Degradation Specifications
Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus Pharmaceuticals (USA ) — Zydus Pharmaceuticals (USA) Inc
-
August 27, 2021 · Class II · Terminated · D-0820-2021
Lack of Assurance of Sterility
Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32 — Glenmark Pharmaceuticals Inc., USA
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 727762, 727954 |
|---|---|
| SPL set ID of the quoted label | 83d7a440-e904-4e36-afb5-cb02b1c919f7 |
| FDA labels (SPL) | 21 |
| FDA applications | NDA021344, NDA210063, NDA210326, 12 ANDA |
| Active ingredients (FDA) | FULVESTRANT |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Faslodex, AstraZeneca Pharmaceuticals LP, effective September 25, 2020; 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 →