BALVERSA Film-coated tablet Ref.[10103] Active ingredients: Erdafitinib

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

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.

Chemical structure of erdafitinib is as follows:

BALVERSA (erdafitinib) tablets are supplied as 3 mg, 4 mg or 5 mg film-coated tablets for oral administration and 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).

Dosage Forms and Strengths

Tablets:

  • 3 mg: Yellow, round biconvex, film-coated, debossed with “3” on one side; and “EF” on the other side.
  • 4 mg: Orange, round biconvex, film-coated, debossed with “4” on one side; and “EF” on the other side.
  • 5 mg: Brown, round biconvex, film-coated, debossed with “5” on one side; and “EF” on the other side.
How Supplied

BALVERSA (erdafitinib) tablets are available in the strengths and packages listed below:

  • 3 mg tablets: Yellow, round biconvex, film-coated, debossed with “3” on one side and “EF” on the other side.
    • Bottle of 56-tablets with child resistant closure (NDC 59676-030-56).
    • Bottle of 84-tablets with child resistant closure (NDC 59676-030-84).
  • 4 mg tablets: Orange, round biconvex, film-coated, debossed with “4” on one side and “EF” on the other side.
    • Bottle of 28-tablets with child resistant closure (NDC 59676-040-28).
    • Bottle of 56-tablets with child resistant closure (NDC 59676-040-56).
  • 5 mg tablets: Brown, round biconvex, film-coated, debossed with “5” on one side and “EF” on the other side.
    • Bottle of 28-tablets with child resistant closure (NDC 59676-050-28).

Drugs

Drug Countries
BALVERSA Canada, Hong Kong, Israel, Turkey, United States
 
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