ustekinumab-auub

FDA Drug Profile — WEZLANA

Drug Details

Generic Name
ustekinumab-auub
Brand Names
WEZLANA
Application Number
BLA761285
Sponsor
Nuvaila Limited
NDC Codes
7
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS, INTRAVENOUS
Active Ingredients
USTEKINUMAB

Indications and Usage

1 INDICATIONS AND USAGE WEZLANA 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) WEZLANA 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) WEZLANA 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) WEZLANA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease. 1.4 Ulcerative Colitis WEZLANA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.