ustekinumab-aekn

FDA Drug Profile — Ustekinumab-aekn, Selarsdi, SELARSDI

Drug Details

Generic Name
ustekinumab-aekn
Brand Names
Ustekinumab-aekn, Selarsdi, SELARSDI
Application Number
BLA761343
Sponsor
Teva Pharmaceuticals USA, Inc.
NDC Codes
8
Dosage Forms
INJECTION, SOLUTION
Routes
SUBCUTANEOUS, INTRAVENOUS
Active Ingredients
USTEKINUMAB-AEKN, USTEKINUMAB

Indications and Usage

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