risankizumab-rzaa

FDA Drug Profile — Skyrizi

risankizumab-rzaa is listed in the FDA National Drug Code directory with 18 NDC codes, marketed under brand name including Skyrizi. Available dosage forms: injection, solution, injection.

Drug Details

Generic Name
risankizumab-rzaa
Brand Names
Skyrizi
Application Number
BLA761105
Sponsor
AbbVie Inc.
NDC Codes
18
Dosage Forms
INJECTION, SOLUTION, INJECTION
Routes
SUBCUTANEOUS, INTRAVENOUS
Active Ingredients
RISANKIZUMAB

Indications and Usage

1 INDICATIONS AND USAGE SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. ( 1.1 ) active psoriatic arthritis in adults and pediatric patients 6 years of age and older. ( 1.2 ) moderately to severely active Crohn's disease in adults. ( 1.3 ) moderately to severely active ulcerative colitis in adults. ( 1.4 ) 1.1 Plaque Psoriasis SKYRIZI ® is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. 1.2 Psoriatic Arthritis SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults and pediatric patients 6 years of age and older. 1.3 Crohn’s Disease SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults. 1.4 Ulcerative Colitis SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults.