Quick answers
- What is Fosaprepitant used for?
- The FDA-approved label (Emend, Merck Sharp & Dohme LLC, February 20, 2026) says: “EMEND ® for injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fosaprepitant have a boxed warning?
- No. None of the 24 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Fosaprepitant?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated April 8, 2026). Ask your pharmacist about alternatives.
- Has Fosaprepitant been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started January 10, 2024 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Fosaprepitant?
- 21 companies list prescription products of Fosaprepitant in the FDA NDC Directory, including Dr. Reddy's Laboratories Inc., BluePoint Laboratories and Hikma Pharmaceuticals USA Inc..
What Fosaprepitant is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
EMEND ® for injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. …
— FDA label: Emend, Merck Sharp & Dohme LLC, effective February 20, 2026. Read the full label on DailyMed →
The FDA has 24 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.
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 24 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.
- Dr. Reddy's Laboratories Inc.3 products
- BluePoint Laboratories3 products
- Hikma Pharmaceuticals USA Inc.2 products
- Novadoz Pharmaceuticals LLC2 products
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.1 product
- Steriscience Specialties Private Limited1 product
- Qilu Pharmaceutical Co., Ltd.1 product
- NorthStar RxLLC1 product
- Mylan Institutional LLC1 product
- Avenacy, LLC1 product
- Baxter Healthcare Corporation1 product
- BE Pharmaceuticals Inc.1 product
- Actavis Pharma, Inc.1 product
- Camber Pharmaceuticals, Inc.1 product
- Merck Sharp & Dohme LLC1 product
- Bryant Ranch Prepack1 product
- Eugia US LLC1 product
- Amneal Pharmaceuticals LLC1 product
- NorthStar Rx LLC1 product
- Avyxa Pharma, LLC1 product
- Fresenius Kabi USA, LLC1 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 |
|---|---|---|---|
| NDA022023 EMEND | Merck and Co Inc | January 25, 2008 | 18, latest May 2, 2022 2022: Efficacy · 2019: Labeling · 2018: Efficacy |
| NDA210064 FOSAPREPITANT DIMEGLUMINE | Teva Pharms USA | September 5, 2019 | — |
| NDA216686 FOCINVEZ | Steriscience | August 22, 2023 | 2, latest March 30, 2026 2026: Labeling · 2025: Labeling |
| NDA220436 NAVITRUX | Avyxa Holdings | June 24, 2026 | — |
Generic approvals (11)
- ANDA206197Fresenius Kabi USA · June 9, 2016
- ANDA204015Mylan Labs Ltd · September 5, 2019
- ANDA205020Apotex · September 5, 2019
- ANDA209965Msn · September 5, 2019
- ANDA211860Baxter Hlthcare Corp · September 5, 2019
- ANDA212309Be Pharms · September 5, 2019
- ANDA213106Qilu Pharm Hainan · September 8, 2020
- ANDA211160DR Reddys · December 9, 2020
- ANDA210625Eugia Pharma · January 12, 2021
- ANDA212143Chia Tai Tianqing · March 3, 2021
- ANDA214616Aspiro · July 29, 2021
Shortage status
To be discontinued · updated April 8, 2026 · first posted April 8, 2026
| Product | Fosaprepitant Dimeglumine, Injection, 150 mg/5 mL (NDC 63323-972-10) |
|---|---|
| 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.
-
January 10, 2024 · Class II · Terminated · D-0262-2024
Lack of Sterility Assurance: Aseptic process simulation failure.
Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 203 New Edition Court — BE PHARMACEUTICALS AG
-
July 13, 2020 · Class III · Terminated · D-1391-2020
Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10 — Fresenius Kabi USA, LLC
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) | 1731077, 1731082, 2745874 |
|---|---|
| SPL set ID of the quoted label | 8d66803a-6811-4c29-9c57-e16acfa87f21 |
| FDA labels (SPL) | 24 |
| FDA applications | NDA022023, NDA210064, NDA216686, NDA220436, 11 ANDA |
| Active ingredients (FDA) | FOSAPREPITANT DIMEGLUMINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Emend, Merck Sharp & Dohme LLC, effective February 20, 2026; 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 →