Prescription medicine
Fosaprepitant Brand names: Focinvez, Navitrux, Emend
Fosaprepitant (Emend) is a prescription medicine with an FDA approval on record since 2008. FDA's NDC Directory lists it from 16 generic labelers.
- Generic listed
- A presentation discontinued
Check it at the source: the fosaprepitant FDA label on DailyMed (effective July 29, 2026, AVYXA Pharma, LLC); the NDA 22023 record on Drugs@FDA; every fosaprepitant label on DailyMed.
Highlights of the record
FDA label of July 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageNAVITRUX, 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.
Forms and strengths
- 150 mg
- 150 mg/5ml
- 150 mg/50ml
Injection (powder) (lyophilized) for solution; injection.
On the market
- Earliest approval on file
- January 25, 2008 Emend, Merck And Co Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 18 first June 9, 2016; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 21 of which 16 under generic applications, 5 under brand applications, repackagers included
- Last listed patent
- January 11, 2039 Focinvez injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- 3 since 2019 0 Class I among all firms' recalls; latest January 10, 2024
- FAERS reports
- 13,668 through July 30, 2026
What is fosaprepitant used for?
From the label: indications and usageNAVITRUX, 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. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use NAVITRUX has not been studied for the treatment of established nausea and vomiting. […]
FDA pharmacologic class: Substance P/Neurokinin-1 Receptor Antagonist.
Source: FDA drug label (NAVITRUX), AVYXA Pharma, LLC, effective July 29, 2026 (SPL set a41b7c3a-1376-43a7-b5b9-6ba2eba1e169), via openFDA; the full label on DailyMed
Is there a generic for fosaprepitant (Emend)?
The FDA approved the first generic fosaprepitant on June 9, 2016. 18 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists fosaprepitant from 16 labelers under a generic (ANDA) application and from 5 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 no patent for Emend injection; a patent listed only for Focinvez injection runs to January 11, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2008 earliest approval on file
- 2016 first generic approved
- 2039 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is fosaprepitant in shortage?
No fosaprepitant presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated April 8, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Fosaprepitant Dimeglumine, Injection, 150 mg/5 mL (NDC 63323-972-10) | Fresenius Kabi USA, LLC | To Be Discontinued | April 8, 2026 |
Every fosaprepitant presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has fosaprepitant been recalled?
The FDA's Enforcement Report lists 3 recalls naming fosaprepitant since 2019: 0 Class I (the most serious), 2 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 10, 2024 | Class II | BE PHARMACEUTICALS AG | Lack of Sterility Assurance: Aseptic process simulation failure. |
| July 13, 2020 | Class III | Fresenius Kabi USA, LLC | Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as … |
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fosaprepitant label say about other medicines?
The fosaprepitant label names 27 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name fosaprepitant. 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 |
|---|---|---|
| Alprazolam | drug interactions | Clinical Impact; Increased exposure to midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) may increase the risk of adverse reactions [see ]. |
| Aprepitant | contraindications | Inhibition of CYP3A4 by aprepitant, the active moiety, could result in elevated plasma concentrations of this drug, which is a CYP3A4 substrate, potentially causing serious or life-threatening reactions, such as QT prolongation, a known adverse reaction of pimozide [see Warnings and Precautions (5.1) ]. |
| Carbamazepine | drug interactions | Examples; rifampin, carbamazepine, phenytoin |
| Clarithromycin | drug interactions | Examples; Moderate inhibitor: diltiazem Strong inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir |
| Dexamethasone | drug interactions | Clinical Impact; Increased dexamethasone exposure [see ]. |
| Diltiazem | drug interactions | Examples; Moderate inhibitor: diltiazem Strong inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir |
| Docetaxel | drug interactions | Etoposide, vinorelbine, paclitaxel, and docetaxel ● No dosage adjustment needed. |
| Etoposide | drug interactions | Etoposide, vinorelbine, paclitaxel, and docetaxel ● No dosage adjustment needed. |
| Granisetron | drug interactions | Examples; ondansetron, granisetron, dolasetron |
| Ifosfamide | drug interactions | Intervention; Vinblastine, vincristine, or ifosfamide or other chemotherapeutic agents ● Monitor for chemotherapeutic-related adverse reactions. Etoposide, vinorelbine, paclitaxel, and docetaxel ● No dosage adjustment needed. |
| Itraconazole | drug interactions | Examples; Moderate inhibitor: diltiazem Strong inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir |
| Ketoconazole | drug interactions | Examples; Moderate inhibitor: diltiazem Strong inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir |
| Methylprednisolone | drug interactions | Clinical Impact; Increased methylprednisolone exposure [see ]. |
| Midazolam | drug interactions | Clinical Impact; Increased exposure to midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) may increase the risk of adverse reactions [see ]. |
Every other medicine the fosaprepitant label names
| Medicine named | Section | What the label says |
|---|---|---|
| Nefazodone | drug interactions | Examples; Moderate inhibitor: diltiazem Strong inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir |
| Nelfinavir | drug interactions | Examples; Moderate inhibitor: diltiazem Strong inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir |
| Ondansetron | drug interactions | Examples; ondansetron, granisetron, dolasetron |
| Paclitaxel | drug interactions | Etoposide, vinorelbine, paclitaxel, and docetaxel ● No dosage adjustment needed. |
| Phenytoin | drug interactions | Examples; rifampin, carbamazepine, phenytoin |
| Pimozide | contraindications | … life-threatening reactions, such as QT prolongation, a known adverse reaction of pimozide [see Warnings and Precautions (5.1) ]. |
| Rifampin | drug interactions | Examples; rifampin, carbamazepine, phenytoin |
| Ritonavir | drug interactions | Examples; Moderate inhibitor: diltiazem Strong inhibitors: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir |
| Triazolam | drug interactions | Clinical Impact; Increased exposure to midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) may increase the risk of adverse reactions [see ]. |
| Vinblastine | drug interactions | Intervention; Vinblastine, vincristine, or ifosfamide or other chemotherapeutic agents ● Monitor for chemotherapeutic-related adverse reactions. … |
| Vincristine | drug interactions | Intervention; Vinblastine, vincristine, or ifosfamide or other chemotherapeutic agents ● Monitor for chemotherapeutic-related adverse reactions. … |
| Vinorelbine | drug interactions | Etoposide, vinorelbine, paclitaxel, and docetaxel ● No dosage adjustment needed. |
| Warfarin | drug interactions | Clinical Impact; Decreased warfarin exposure and prolongation of prothrombin time (INR) [see, ]. |
Source: FDA drug label (NAVITRUX), AVYXA Pharma, LLC, effective July 29, 2026 (SPL set a41b7c3a-1376-43a7-b5b9-6ba2eba1e169), via openFDA; the full label on DailyMed
What do FAERS reports show for fosaprepitant?
The FDA Adverse Event Reporting System holds 13,668 reports that list fosaprepitant among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,220 are coded as a death and 7,095 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 next?
- Other substance p/neurokinin-1 receptor antagonists
- the pharmacologic class, with prices and generics
- Fosaprepitant side effects
- the label's list beside FAERS reports
- Fosaprepitant shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other