golimumab

FDA Drug Profile — SIMPONI ARIA, Simponi

golimumab is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand names including SIMPONI ARIA, Simponi. Available dosage forms: solution, injection, solution.

Drug Details

Generic Name
golimumab
Brand Names
SIMPONI ARIA, Simponi
Application Number
BLA125433
Sponsor
Janssen Biotech, Inc.
NDC Codes
4
Dosage Forms
SOLUTION, INJECTION, SOLUTION
Routes
INTRAVENOUS, SUBCUTANEOUS
Active Ingredients
GOLIMUMAB

Indications and Usage

1 INDICATIONS AND USAGE SIMPONI ARIA is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate ( 1.1 ) Active Psoriatic Arthritis (PsA) in patients 2 years of age and older ( 1.2 ) Adult patients with active Ankylosing Spondylitis (AS) ( 1.3 ) Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older ( 1.4 ) 1.1 Rheumatoid Arthritis (RA) SIMPONI ARIA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. 1.2 Psoriatic Arthritis (PsA) SIMPONI ARIA is indicated for the treatment of active psoriatic arthritis in patients 2 years of age and older. 1.3 Ankylosing Spondylitis (AS) SIMPONI ARIA is indicated for the treatment of adult patients with active ankylosing spondylitis. 1.4 Polyarticular Juvenile Idiopathic Arthritis (pJIA) SIMPONI ARIA is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older.