ustekinumab

FDA Drug Profile — YESINTEK, STELARA, ustekinumab, Stelara

Drug Details

Generic Name
ustekinumab
Brand Names
YESINTEK, STELARA, ustekinumab, Stelara
Application Number
BLA761406
Sponsor
Biocon Biologics Inc.
NDC Codes
10
Dosage Forms
INJECTION, SOLUTION, SOLUTION
Routes
SUBCUTANEOUS, INTRAVENOUS
Active Ingredients
USTEKINUMAB

Indications and Usage

1 INDICATIONS AND USAGE IMULDOSA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: • moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. ( 1.1 ) • active psoriatic arthritis (PsA). ( 1.2 ) • moderately to severely active Crohn’s disease (CD). ( 1.3 ) • moderately to severely active ulcerative colitis. ( 1.4 ) Pediatric patients 6 years and older with: • moderate to severe plaque psoriasis (PsO), who are candidates for phototherapy or systemic therapy. ( 1.1 ) • active psoriatic arthritis (PsA). ( 1.2 ) 1.1 Plaque Psoriasis (PsO) IMULDOSA is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. 1.2 Psoriatic Arthritis (PsA) IMULDOSA is indicated for the treatment of adults and pediatric patients 6 years of age and older with active psoriatic arthritis. 1.3 Crohn’s Disease (CD) IMULDOSA is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease. 1.4 Ulcerative Colitis IMULDOSA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.