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These highlights do not include all the information needed to use BALVERSA safely and effectively. See full prescribing information for BALVERSA. BALVERSA ®(erdafitinib) tablets, for oral use Initial U.S. Approval: 2019
Medication labelWhy this: Advisory · dailymed-prescription
BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA [see Dosage and Administration (2.1)and Clinical Studies (14.1)] . Limitations of Use BALVERSA is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy [see Clinical Studies (14.1)] .
- generic_name
- erdafitinib
- product_names
- Erdafitinib
- ndc
- 59676-030, 59676-040, 59676-050, 59676-040-28, 59676-040-56, 59676-030-56, 59676-030-84, 59676-050-28
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en