Prescription medicine
Tovorafenib Brand names: Ojemda
Tovorafenib (Ojemda) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the tovorafenib FDA label on DailyMed (effective September 2, 2025, Day One Biopharmaceuticals, Inc.); the NDA 217700 record on Drugs@FDA; every tovorafenib label on DailyMed.
Highlights of the record
FDA label of September 2, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageOJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
Forms and strengths
- 100 mg
Film-coated tablet; kit.
On the market
- Earliest approval on file
- April 23, 2024 Ojemda, Day One Biopharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- June 23, 2035 Ojemda tablets; 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
- 292 through July 30, 2026
What is tovorafenib used for?
From the label: indications and usageOJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). OJEMDA is a kinase inhibitor indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. […]
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (OJEMDA), NDA217700 (Day One Biopharms), as published by Day One Biopharmaceuticals, Inc., effective September 2, 2025 (SPL set ea3a9631-3a66-6a7c-e053-2995a90ae2ad), via openFDA; the full label on DailyMed
What does the patient leaflet for tovorafenib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking OJEMDA?Limit the amount of time you spend in sunlight. OJEMDA can make your skin sensitive to the sun (photosensitivity). Use sun protection measures, such as sunscreen, sunglasses and wear protective clothes that cover your skin during your treatment with OJEMDA.
From the patient leaflet: How should I store OJEMDA?OJEMDA tablets: Store OJEMDA tablets at room temperature between 68˚F to 77˚F (20˚C to 25˚C). Keep OJEMDA tablets in its original package. Tablets should not be removed from blister cards until right before use. OJEMDA for oral suspension: Store the glass bottle containing OJEMDA for oral suspension at room temperature between 68˚F to 77˚F (20˚C to 25˚C). Do not use OJEMDA for oral suspension if the safety seal under the cap is broken or missing. Throw away your bottle(s), including any unused or expired OJEMDA for oral suspension, and oral dosing syringe after taking or giving a dose. Keep OJEMDA and all medicines out of the reach of children.
Source: FDA drug label (OJEMDA), NDA217700 (Day One Biopharms), as published by Day One Biopharmaceuticals, Inc., effective September 2, 2025 (SPL set ea3a9631-3a66-6a7c-e053-2995a90ae2ad), via openFDA; the full label on DailyMed
Is there a generic for tovorafenib (Ojemda)?
No generic tovorafenib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Ojemda tablets: the compound patent runs to August 4, 2031, and the last listed entry to June 23, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for tovorafenib?
The FDA Adverse Event Reporting System holds 292 reports that list tovorafenib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 12 are coded as a death and 34 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.
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
- Tovorafenib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other