U.S. License Holder:
Centocor Ortho Biotech Inc. (Janssen Biotech, Inc.)
Date of License:
September-25-2009 [September-23-2016]
Last Update:
March-31-2020
FDA-Approved Indications
BL 125261: STELARA (ustekinumab) is a human interleukin-12 and -23 antagonist indicated for the treatment of:
Adult patients with:
Moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy;
Active psoriatic arthritis (PsA), alone or in combination with methotrexate;
Moderately to severely active Crohn's disease (CD) who have failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed a tumor necrosis factor (TNF) blocker or failed or were intolerant to treatment with one or more TNF blockers;
Adolescent patients (12 years or older) with: moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy.
BL 761044: STELARA (ustekinumab) is a human interleukin-12 and -23 antagonist indicated for the treatment of:
Adult patients with:
Moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy;
Active psoriatic arthritis (PsA), alone or in combination with methotrexate;
Moderately to severely active Crohn's disease (CD);
Moderately to severely active ulcerative colitis.
Adolescent patients (12 years or older) with: moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy.
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