ustekinumab-auub

FDA Drug Profile — WEZLANA

ustekinumab-auub is listed in the FDA National Drug Code directory with 7 NDC codes, marketed under brand name including WEZLANA. Available dosage form: injection, solution.

Drug Details

Generic Name
ustekinumab-auub
Brand Names
WEZLANA
Application Number
BLA761331
Sponsor
Nuvaila Limited
NDC Codes
7
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS, SUBCUTANEOUS
Active Ingredients
USTEKINUMAB

Indications and Usage

1 INDICATIONS AND USAGE WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. ( 1.1 ) Active psoriatic arthritis in adult and pediatric patients 6 years of age and older. ( 1.2 ) Moderately to severely active Crohn's disease in adult patients. ( 1.3 ) Moderately to severely active ulcerative colitis in adult patients . ( 1.4 ) 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 (UC) WEZLANA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.