Quick answers
- What is Rolapitant used for?
- The FDA-approved label (Varubi, Luria Therapeutics LLC, September 8, 2026) says: “VARUBI ® is indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Rolapitant have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Rolapitant?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Rolapitant been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Rolapitant?
- 2 companies list prescription products of Rolapitant in the FDA NDC Directory, including TerSera Therapeutics LLC and Luria Therapeutics LLC.
What Rolapitant is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VARUBI ® is indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. …
— FDA label: Varubi, Luria Therapeutics LLC, effective September 8, 2026. Read the full label on DailyMed →
The FDA has 2 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 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Varubi |
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.
- TerSera Therapeutics LLC1 product
- Luria Therapeutics LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA206500 VARUBI | Tersera | September 1, 2015 | 4, latest August 19, 2020 2020: Labeling · 2018: Labeling · 2016: Manufacturing (CMC) |
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) | 1665503, 1673373 |
|---|---|
| SPL set ID of the quoted label | 8670c3cf-82d9-466d-be49-de33d8c8742b |
| FDA labels (SPL) | 2 |
| FDA applications | NDA206500 |
| Active ingredients (FDA) | ROLAPITANT |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Varubi, Luria Therapeutics LLC, effective September 8, 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 →