Prescription medicine
Vimseltinib Brand names: Romvimza
Vimseltinib (Romvimza) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the vimseltinib FDA label on DailyMed (effective June 26, 2026, Deciphera Pharmaceuticals, LLC); the NDA 219304 record on Drugs@FDA; every vimseltinib label on DailyMed.
Highlights of the record
FDA label of June 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
Forms and strengths
- 14 mg
- 20 mg
- 30 mg
Capsule.
On the market
- Earliest approval on file
- February 14, 2025 Romvimza, Deciphera Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- April 30, 2045 Romvimza capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 532 through July 30, 2026
What is vimseltinib used for?
From the label: indications and usageROMVIMZA is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity. ROMVIMZA is a kinase inhibitor indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (ROMVIMZA), Deciphera Pharmaceuticals, LLC, effective June 26, 2026 (SPL set f73c7a62-9601-4df0-810f-100f515d79ea), via openFDA; the full label on DailyMed
What does the patient leaflet for vimseltinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ROMVIMZA?ROMVIMZA can cause serious side effects, including: Liver problems. Increased liver enzymes in your blood are common with ROMVIMZA. Your healthcare provider will do blood tests to check for liver problems: before starting treatment with ROMVIMZA, 2 times each month for the first 2 months of treatment, then 1 time every 3 months for the first year of treatment and as clinically indicated thereafter. If you develop liver problems during treatment with ROMVIMZA, your healthcare provider may temporarily stop treatment, decrease your dose, or permanently stop treatment depending on how severe your liver problems are. Tell your healthcare provider right away if you develop any signs or symptoms of liver problems during treatment with ROMVIMZA including: yellowing of your skin or the white part of your eyes dark urine lack or loss of appetite right upper stomach-area (abdomen) pain or tenderness feeling overly tired nausea vomiting fever rash itching See “ What are the possible side effects of ROMVIMZA? ” for more information about side effects.
From the patient leaflet: How should I store ROMVIMZA?Store ROMVIMZA capsules at room temperature between 68ºF to 77ºF (20ºC to 25ºC). Store ROMVIMZA capsules in the original blister pack until you are ready to take them. Do not store ROMVIMZA capsules in another container. The blister packs are child resistant. Keep ROMVIMZA and all medicines out of the reach of children.
Source: FDA drug label (ROMVIMZA), Deciphera Pharmaceuticals, LLC, effective June 26, 2026 (SPL set f73c7a62-9601-4df0-810f-100f515d79ea), via openFDA; the full label on DailyMed
Is there a generic for vimseltinib (Romvimza)?
No generic vimseltinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 13 patents for Romvimza capsules: the compound patent runs to December 6, 2044, and the last listed entry to April 30, 2045. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2045 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the vimseltinib label say about other medicines?
The vimseltinib label names 1 other medicine in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Aspirin | warnings and precautions | Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin sensitivity. |
Source: FDA drug label (ROMVIMZA), Deciphera Pharmaceuticals, LLC, effective June 26, 2026 (SPL set f73c7a62-9601-4df0-810f-100f515d79ea), via openFDA; the full label on DailyMed
What do FAERS reports show for vimseltinib?
The FDA Adverse Event Reporting System holds 532 reports that list vimseltinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 19 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 kinase inhibitors
- the pharmacologic class, with prices and generics
- Vimseltinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other