Erdafitinib
Erdafitinib is listed in the FDA National Drug Code directory with 5 NDC codes, marketed under brand name including BALVERSA. Available dosage forms: powder, tablet, film coated.
Drug Details
- Generic Name
- Erdafitinib
- Brand Names
- BALVERSA
- Application Number
- NDA212018
- Sponsor
- Cilag AG
- NDC Codes
- 5
- Dosage Forms
- POWDER, TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- ERDAFITINIB
Indications and Usage
1 INDICATIONS AND USAGE BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic 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) ] . BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic 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. ( 1 , 2.1 ) 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. ( 1 , 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) ] .