Balversa Description

BALVERSA (erdafitinib) is supplied as 3 mg, 4 mg or 5 mg film-coated tablets for oral administration.
BALVERSA (erdafitinib) 3 mg tablets are yellow, round biconvex, film-coated, debossed with "3" on one side and "EF" on the other side.
BALVERSA (erdafitinib) 4 mg tablets are orange, round biconvex, film-coated, debossed with "4" on one side and "EF" on the other side.
BALVERSA (erdafitinib) 5 mg tablets are brown, round biconvex, film-coated, debossed with "5" on one side and "EF" on the other side.
Erdafitinib, the active ingredient in BALVERSA, is a kinase inhibitor. The chemical name is N-(3,5-dimethoxyphenyl)-N'-(1-methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine. Erdafitinib is a yellow powder. It is practically insoluble, or insoluble to freely soluble in organic solvents, and slightly soluble to practically insoluble, or insoluble in aqueous media over a wide range of pH values. The molecular formula is C₂₅H₃₀N₆O₂ and molecular weight is 446.56.
Excipients/Inactive Ingredients: BALVERSA (erdafitinib) contains the following inactive ingredients: Tablet Core: Croscarmellose sodium, Magnesium stearate (from vegetable source), Mannitol, Meglumine, and Microcrystalline cellulose.
Film Coating (Opadry amb II): Glycerol monocaprylocaprate type I, Polyvinyl alcohol-partially hydrolyzed, Sodium lauryl sulfate, Talc, Titanium dioxide, Iron oxide yellow, Iron oxide red (for the orange and brown tablets only), Ferrosoferric oxide/iron oxide black (for the brown tablets only).