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These highlights do not include all the information needed to use OJEMDA safely and effectively. See full prescribing information for OJEMDA. OJEMDA (tovorafenib) tablets, for oral use OJEMDA (tovorafenib) for oral suspension Initial U.S. Approval: 2024
Medication labelWhy this: Advisory · dailymed-prescription
OJEMDA 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).
- generic_name
- tovorafenib
- product_names
- tovorafenib, TOVORAFENIB
- ndc
- 82950-112, 82950-012, 82950-001, 82950-012-01, 82950-112-10, 82950-001-06, 82950-001-24, 82950-001-05, 82950-001-20, 82950-001-04, 82950-001-16
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en